Author: incannex@admin

Results from a Phase-1 clinical of Incannex’s anti-inflammatory drug IHL-675A in healthy volunteers adds to the company’s confidence in proceeding with assessment in patients with inflammatory diseases.

Medicinal cannabis and psychedelic therapies company, Incannex Healthcare (ASX: IHL) has announced promising final results from the Phase-1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A.

IHL-675A is a combination cannabinoid drug comprising cannabidiol (CBD) and hydroxychloroquine (HCQ) in a fixed dose combination.

IHL-675A was observed to outperform either CBD and HCQ in various pre-clinical models of inflammation, including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

Synergistic anti-inflammatory activity of CBD and HCQ was observed in these distinct pre-clinical studies and was evidence to support the company’s international patent application over the drug.

The Phase-1 trial measured the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to reference listed drugs, Epidiolex (CBD) and Plaquenil (HCQ).

Three cohorts of 12 participants – 36 in total – received either IHL-675A, CBD or HCQ and the clinical assessments were identical across the three arms of the trial.

Participants were monitored for adverse events and had blood samples collected for
pharmacokinetic (PK) analysis over a four-week period.

PK analysis determines the absorption, distribution, metabolism, and excretion (also known as ADME) of drugs in the body.

The trial was conducted by CMAX Clinical Research in Adelaide and managed by Avance Clinical.

Safety and tolerability results

IHL-675A was well tolerated, with no adverse events of concern and no serious adverse events reported.

The same number of treatment-related Treatment Emergent Adverse Events (TEAEs) were reported for IHL-675A as for Epidiolex.

TEAEs included abdominal pain, dizziness, fatigue, frequent bowel movements, headache, and somnolence.

All TEAEs were minor except one incidence of moderate severity abdominal cramps which resolved soon after onset.

Both active pharmaceutical ingredients, CBD and HCQ, are absorbed from IHL-675A.

Trends in PK profiles indicate that the uptake of CBD may be more rapid for IHL-675A than Epidiolex and uptake of HCQ may be slower for IHL-675A than Plaquenil.

This could be advantageous for IHL-675A. CBD provides immediate relief for inflammation and pain whereas HCQ is a slower acting molecule and provides extended relief.

Crucial step to move forward

The safety and pharmacokinetic data from the Phase-1 clinical trial in healthy volunteers adds to the company’s confidence in proceeding with assessment of IHL-675A in patients with inflammatory diseases.

IHL chief scientific officer Dr Mark Bleackley said results from the Phase-1 trial are a critical milestone in the development of IHL-675A.

“Data on the safety and pharmacokinetics of the drug combination are essential for supporting to administration of the drug to rheumatoid arthritis patients on a daily basis over an extended period in the Phase-2 trial,” he said.

“We are excited to better understand the therapeutic potential of IHL-675A as the development pipeline continues to progress.”

Next Steps – Phase-2 Trial in rheumatoid arthritis patients

IHL said as HCQ is already approved for treatment of rheumatoid arthritis, it is the first indication for which IHL-675A will be assessed in a Phase-2 clinical trial.

The trial will include 120 participants who meet the eligibility criteria, and participants will be randomised to one of four arms – either IHL-675A, CBD alone, HCQ alone or placebo.

The primary endpoint for the study is pain and function relative to baseline
determined via the score on the RAPID3 assessment at 24 weeks. 

Plans for Phase-2 trial in other inflammatory diseases

Trial designs for Phase-2 studies in patients with inflammatory bowel disease and lung inflammation are also being developed.

The treatment of these three indications has a combined global annual market
size of exceeding US$125 billion annually.

IHL has filed a request for pre-IND meeting on the development of IHL-675A for treatment of arthritis with the US Food and Drug Administration (FDA).

Following the pre-IND meeting, IHL intends to open an IND in parallel with the Australian Phase-2 study.

This will enable trials in the US if the Australian study continues to support the therapeutic potential of IHL-675A in patients with arthritis.

Positive in-vivo results

In March of 2021, IHL announced results from an in vivo model of rheumatoid arthritis where IHL-675A was observed to benefit the treatment of rheumatoid arthritis in mice greater than that of CBD or HCQ alone.

HCQ, is widely used for treatment of rheumatoid arthritis in the form of hydroxychloroquine sulphate, marketed as Plaquenil.

An improvement to patient wellbeing achieved by IHL-675A would potentially open a major economic opportunity for IHL arthritis.

IHL CEO and managing director Joel Latham said a large sub-group of people with rheumatoid arthritis are using hydroxychloroquine or cannabidiol to help to alleviate their symptoms.

“We are delighted with the safety data and with the unique pharmacokinetic characteristics of IHL-675A that may be beneficial for patients with rheumatoid arthritis,” he said.

“By undertaking pivotal clinical studies over IHL-675A, we intend to disrupt the markets for both CBD and hydroxychloroquine as they currently pertain to the treatment of rheumatoid arthritis.”

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Incannex has made a key appointment as it works to advance its CannQuit-N (Nicotine), CannQuitO (Opioid) and Renecann products in the USA and EU.

Medicanal cannabis and psychedelic therapies company, Incannex Healthcare (ASX: IHL) has announced that it has appointed Quest Pharmaceutical Services (QPS) to provide regulatory advice and manage clinical trials for the development of its CannQuit and ReneCann products for addiction and immune-disordered skin diseases.

QPS was founded in 1995 to provide high-quality bioanalytical LC-MS/MS contract services and has grown from a small molecule bioanalysis shop of three people to more than 1,250+ employees in the US, Europe, India, and Asia.

Over the years, QPS has adopted additional services, including neuropharmacology, DMPK, toxicology, translational medicine, early phase clinical research and phase-2 through to phase-4 clinical research.

QPS is currently drafting pre-investigational new drug (pre-IND) submissions for both the European Union’s European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the CannQuit and ReneCann products.

Once advice from the regulators is received, QPS will retain a leading role in the management of clinical trials, which will be undertaken to provide relevant evidence of safety and efficacy.

CannQuit-N^TM aims to improve outcome of nicotine-only gum

CannQuit-Nicotine (N) is a  controlled-release, pharmaceutical-grade (cGMP) medicated chewing gum formulation comprising cannabidiol (CBD) and nicotine.

Nicotine chewing gum is already an  accepted treatment and maintenance product throughout the globe with annual sales amounting to US $5.2 billion in 2020, however, progression to complete smoking cessation is limited.

By adding CBD in a proprietary combination, CannQuit-N is hypothesised by IHL to improve upon the therapeutic outcomes of nicotine only gum.

Eurofins was appointed in November 2022 to manufacture IHL’s medicated chewable products designed to treat nicotine and opioid addiction disorders.

CannQuit-Opiod (O) to tackle critical opioid addiction

CannQuit-Opioid (O) is a controlled-release, pharmaceutical-grade medicated chewing tablet formulation combining CBD and an opioid antagonist/agonist in a proprietary water-soluble chewable tablet for the treatment of opioid addiction.

The water-soluble chewable tabletis uniquely loaded with a high CBD dose and in addition the unique polymer composition that ensures faster onset and higher bioavailability. At present, stability evaluation is being done for the pharmaceutical ingredients within CannQuit-O.

The opioid epidemic has reached critical levels in the US and the industrialised world.

Fatal opioid overdoses and opioid use disorder cost the US $1.02 trillion in 2017, as measured by the Centre for Disease Control (CDC) in the journal Drug and Alcohol Dependence, which is the most complete accounting of America’s opioid crisis to date.

Treatments for opioid use disorder total US$64 billion annually and there have been no major new treatment solutions in recent decades.

ReneCann to provide relief from common skin conditions

ReneCann is IHL’s proprietary topical cannabinoid formulation for treatment of dermatological conditions caused by disorders of the immune system, including vitiligo, psoriasis, and atopic dermatitis, otherwise known as eczema.

The unique formulation combines Cannabigerol (CBG), a non-psychoactive cannabinoid with potent anti-inflammatory properties, and CBD.

A previous version of ReneCann was formulated by US-based APIRx Pharmaceuticals, which IHL acquired in 2022.

The study was conducted at the Maurits Clinic, The Netherlands, and led by a world-renowned dermatologist Dr Marcus Meinardi.

In the study, ReneCann reduced disease scores in patients with each of the target skin diseases.

Patients with vitiligo, psoriasis and atopic dermatitis were observed to experience improvements in symptoms of 10%, 33% and 22% respectively.

IHL said, the results for study participants with vitiligo were encouraging because the incidence of the disease is high at 0.5-1.0% of the global population with limited treatments.

QPS engagement to fast-track commercialisation

 IHL CEO and managing director Joel Latham said QPS was a perfect fit for the company to develop and commercialise the products globally.

“Not only will QPS assist us with conducting clinical research, but it has also been engaged to advise upon the quickest route to commercialising the products in different regulatory jurisdictions,” he said.

“The CannQuit and ReneCann products are patent protected and were acquired as part of the acquisition of APIRx Pharmaceuticals completed in 2022.”

He said data collected by Eurofins during development manufacturing on the quality and stability of the products will be key components of future regulatory packages aimed at achieving commercialisation.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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IHL is undergoing a pivotal point in its journey as a company moving from pure research to service delivery as Australia becomes the first country to recognise psychedelics as medicine.

Incannex Healthcare (ASX: IHL) has announced that it has developed plans for the commercialisation and launch of multiple psychedelic-assisted psychotherapy clinics, the first of which will open in Melbourne in 2023.

Incannex is at an advanced stage of negotiation on riverfront premises for its first clinic in Melbourne and hopes to roll out many more as the market potential is what it has referred to as a “multi-billion dollar opportunity”.

IHL said it has been developing commercialisation plans for psychedelic clinics for some time, well before the Therapeutic Goods Administration (TGA) decision to down-schedule psilocybin for treatment-resistant depression (TRD) and MDMA for Post-Traumatic Stress Disorder (PTSD) was announced.

Psychedelic Clinics have been developed under the leadership of Peter Widdows, a long-standing IHL director.

“When the TGA announced the down-scheduling of MDMA and psilocybin for two indications, we were in a perfect position to expand our plans to cover this wider set of related therapies for certain indications,” Widdows said.

“This is both an amazing opportunity to do some good for humankind by delivering high-quality, effective treatments for  debilitating conditions that often don’t respond to available treatments, and a great business opportunity, with a market that is predicted to mature into a multi-billion-dollar industry segment.”

Partnerships with clinical professionals

IHL has entered a partnership with Australia’s leading clinical psychedelic professionals, who all have extensive experience within clinical psychedelic research, treatment, and training.

Co-founder, director, chief strategy, and chief scientific officer Paul Liknaitzky has played a central role in establishing the clinical psychedelic field in Australia and leads the largest group of psychedelic researchers and clinicians in the country.

He is the chief principal investigator on a program of psychedelic trials and collaborates on numerous others nationally.

He has led the development of psychedelic trial protocols, treatment design, trial coordination, therapist selection and training, and has established active collaborations with an extensive network of international experts and organisations in the field.

His work is focused on developing innovative therapies, evaluating benefits, exploring potential drawbacks, predicting treatment response, mitigating risks, understanding therapeutic mechanisms, and translating research into practice.

“The safe, useful, and ethical translation of clinical psychedelic research into practice has been at the forefront of my mind for some years, as we conduct trials and learn first-hand about the potential and the complexity of providing  psychedelic therapies,” Liknaitzky said.

“Very few people in Australia have the unique expertise and experience in delivering psychedelic therapies, and it is incumbent on those who do, to set the highest standards in patient safety, quality of care, ethical conduct, and accessibility.”

Leading transition to psychedelic-assisted psychotherapy

Co-founder, director chief medical officer and head of psychiatry Professor Suresh Sundram has led more than 50 clinical trials and studies in psychiatric disorders and has extensive experience with the use of psychedelics within psychotherapy.

“The down-scheduling of certain psychedelic treatments for certain conditions is an important  transition point to establish the  utility and role of psychedelic-assisted psychotherapy in mental illness,” Sundram said.

“Providing a custom-tailored environment to deliver the best possible therapeutic experience is critical.

“To enable this, and to evaluate and deliver outcomes, is a rare opportunity.”

Co-founder, director and head of psychotherapy Sean O’Carroll is an integrative psychotherapist and academic specialising  in  experiential, relational, and transpersonal psychotherapy.

Since 2019, he has developed and delivered psychedelic-assisted psychotherapy training for several clinical psychedelic research  teams.

O’Carroll began lecturing in transpersonal psychology in 2011 and has more than 10 years’ experience working with what he calls “psychedelic casualties”.

Through the Wild Mind Institute, he offers training for mental health practitioners in psychedelic-assisted psychotherapy, “bad trip” integration, and eco-psychotherapy.

“Many of us in the research community were surprised by the recent TGA announcement, understanding this research is still in its early stages here in Australia, and that a good deal of necessary infrastructure is not yet in place,” O’Carroll  said.

“With this decision, those of us who have the experience and  expertise in this field feel a responsibility to contribute to the best  possible care and provide a benchmark for safe and ethical practice. “

“There are very few experienced psychedelic-assisted psychotherapists in Australia, and the team we are assembling includes many of the most experienced practitioners in the country.”

Pivotal point in IHL’s journey

IHL is at an advanced stage of negotiations over locations in Melbourne with the first model clinic expected to open before the end of 2023.

Once the operation of the model clinic is running smoothly, IHL plans to begin rapid expansion within Australia and overseas, where legislation allows.

“This opportunity is something the IHL team have been working towards for some time now and presents a pivotal point in the journey of the company, turning from pure research into service delivery,” IHL managing director and CEO Joel Latham said.

“The opportunity is to deliver the highest-quality care and make a real difference in people’s lives, alongside substantial and imminent revenue potential.”

He said implementation of Psychedelic Clinics won’t impact development of its core clinical assets and will be run as an IHL-owned subsidiary in parallel.

IHL is currently undergoing a Phase 2 clinical trial for its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), in a clinical trial program also known as “PsiGAD”.

“Implementation of this strategy will in part provide the platform to allow an accelerated path to commercialisation for our drug assets post clinical success,” he said.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Even though specific data from the PsiGAD trial cannot yet be released until the trial is completed, positive interim results of the Phase-2 clinical trial has given Incannex the encouragement to commence drafting an FDA IND application

Incannex Healthcare (ASX:IHL) says that an interim review of its clinical trial data has indicated no safety concerns, and even projected a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm in those patients who have completed the treatment.

The pharmaceutical cannabinoid and psychedelics company is currently undergoing a  Phase-2 clinical trial for its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), in a clinical trial program also known as “PsiGAD”.

From the interim data so far, IHL found there is a high probability (greater than 85% with 95% confidence level) that the  study, when completed, will show a statistically significant benefit for the psilocybin treatment arm over the placebo treatment arm.

This projection is made by assuming the effect size observed in the current 29 participants will be representative of the effect size through the remaining 43 participants of the 72 person trial.

First announced in December 2020,  this Phase-2 study is a world-first clinical trial conducted through a partnership between Incannex and Monash University, and is led by Dr Paul Liknaitzky, a Research Fellow at the University.

“The results from the interim analysis of our Phase-2 clinical trial provide us with encouragement that our PsiGAD psilocybin-assisted psychotherapy treatment protocol has the potential to transform the lives of people suffering from anxiety,” said Incannex CEO, Joel Latham.

“Even though the results must remain blinded until the conclusion of the trial, the confidential review has given us the confidence to commence manufacture of our own psilocybin drug product with the appointment of Catalent, progress planning of our pivotal trials and commence drafting our FDA IND application for the PsiGAD treatment program.

“The Clinical Psychedelic Lab at Monash University has overseen training of 14 psychotherapists to work on the phase 2 trial, demonstrating that this transformational treatment is scalable to many therapists and patients throughout the world.”

A huge market opportunity to treat GAD

GAD affects millions of people across the globe each year, and is characterised by excessive anxiety and worry that occurs more days than not for at least 6 months.

The disease is not restricted to any particular environmental circumstances, and symptoms include feelings of persistent and excessive worry, nervousness, restlessness, difficulty concentrating, and a range of somatic manifestations.

People with GAD find it difficult to control their worry, which may cause significant distress and impairment in social, occupational, or other areas of functioning.

And as with other mood disorders, current treatments of GAD remain inadequate, with less than half of patients achieving remission following evidence-based treatment, alongside high relapse rates, and substantial treatment side-effects or cost.

Incannex’ psilocybin-assisted psychotherapy aims to address this market gap by using psilocybin to improve the effectiveness of psychotherapy for GAD sufferers.

The treatment in the Phase-2 trial involves two administrations of psilocybin in conjunction with psychotherapy, in a controlled clinical setting as part of a 10-week course of specialised treatment.

Commencement of FDA application

The trial employs a team of experienced and qualified clinicians and researchers who undergo specialist training before they deliver and assess the treatment.

To date, over 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment.

Treatment of all 72 trial participants is anticipated to be completed in the fourth quarter of 2023.

The end point used in the study was a reduction in Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline, which is the primary endpoint in the trial.

The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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As Australia becomes the first country to recognise psychedelics as medicine, Incannex Healthcare is going to start manufacturing its own psilocybin drug product, boosting both trial and commercial opportunities.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has engaged Catalent to develop and manufacture cGMP-grade psilocybin drug product.

IHL said the product will be used in its proprietary psilocybin-assisted psychotherapy drug development program along with potential wider commercial use.

Development and manufacture of a psilocybin drug product follows an internal analysis of the interim data from its PsiGAD Phase 2 clinical trial, giving IHL confidence to proceed with formulation development and pharmaceutical-grade manufacture of its own psilocybin.

Incannex’s PsiGAD Phase 2 clinical trial is assessing its psilocybin-assisted psychotherapy for treatment of generalised anxiety disorder (GAD), often known as a severe form of anxiety.

PsiGAD is the most advanced clinical trial in Australia with 72 patients undertaking the psychedelic-assisted psychotherapy trial at Monash University. IHL has already sought FDA guidance on the trial through a pre-IND meeting completed in 2021.

Interim results from the PsiGAD trial have been received by IHL but remain internally confidential to maintain blinding and integrity of the trial, however, a report from the independent data safety monitoring board (DSMB) on the interim results is expected to be released soon.

Trials and commercial opportunities boost

Australia has become the first country in the world to recognise psychedelics as medicine, after the Therapeutic Goods Administration (TGA) approved psychedelic substances used in magic mushrooms and MDMA.

From July 1 this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.

The move is a welcome move by IHL. CEO and managing director Joel Latham said having its own source of pharmaceutical grade psilocybin enables the company to freely undertake clinical trials.

“It also creates and assists with several commercial opportunities which are at an advanced stage of investigation by the company, and will be announced in the coming weeks, following board appraisal and approval,” he said.

Catalent has been engaged to develop the formulation, generate required quality and stability data for regulatory filings, and establish cGMP manufacture of a drug product to be used in future clinical trials.

The proposed manufacturing process will be designed so that it will be scalable to commercial supply levels when appropriate.

“Engaging Catalent for development and cGMP manufacture of Incannex’s psilocybin drug project is an important milestone for the PsiGAD program,” IHL chief scientific officer Dr Mark Bleackley said.

Incannex also has a licensing arrangement with Monash University over a VR environment that it intends to use as a VR therapy tool in combination with psychedelic drugs to develop a new treatment for other severe forms of anxiety disorders.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Independent analysis has started of Incannex’s Phase 2 clinical trial to assess its psilocybin-assisted psychotherapy for treatment  of  generalised  anxiety disorder  (GAD).

The Incannex (ASX:IHL) phase 2 PsiGAD1  clinical  trial has achieved its interim milestone of 29 patients completing primary endpoint assessments with interim analysis now underway.

Psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions.

PsiGAD1 was developed in collaboration with head of the clinical Psychedelic Lab at Monash University and member of IHL’s scientific advisory board Dr Paul Liknaitzky.

The study is being conducted at Monash University’s BrainPark under the leadership of Liknaitzky.

Co-investigators are Monash head of the department of psychiatry Professor Suresh Sundram and director of BrainPark Professor Murat Yücel.

Dr Liknaitzky has recruited experienced and qualified clinicians and researchers to undergo specialist training and deliver and assess the treatment.

IHL said treatment of GAD with currently accepted medications and therapies remains inadequate, with less than half of patients achieving remission.

Safety and efficacy being assessed

The trial is designed to assess the safety and efficacy of IHL’s unique psilocybin program in an active placebo-controlled study.

The 10-week treatment program includes two dosing sessions with either psilocybin or active placebo.

Safety, efficacy, quality of life and other aspects of mental and physical health are assessed.

To date, 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment.

The interim analysis of the study data to date is being conducted by an independent Data Safety Monitoring Board (DSMB) comprising experts who are not part of the trial.

Recommendations from the DSMB will be provided in March 2023.

So far, so good

The trial continues to progress well and on time,  with  retention  of  all  participants  who  have  been  enrolled.

The  trial  team  have identified no safety concerns to date. The interim analysis will allow IHL to make key decisions on regulatory strategy and, in parallel, planning of pivotal studies, while continuing to collect data from the PsiGAD1 trial.

Patient recruitment is ongoing towards fulfilling the complete study cohort of 72 patients.

At forefront of psychedelic research and development

Liknaitzky said the  PsiGAD1  trial  is  supported  by  a  fantastic  team  of  researchers  and clinicians  and has  been  an intensive and gratifying project to lead.

“I look  forward  to  the  recommendations  of  the  Data  Safety  Monitoring  Board,  and  to continuing to progress this trial to completion.”

IHL chief  scientific  officer Dr  Mark  Bleackley said Monash University is a  major  globally recognised  and highly innovative  university.

He said Liknaitzky  and  his  team are  at  the  forefront  of psychedelic research and development.

“IHL continues to benefit from the academic rigour that Monash University and Dr Liknaitzky bring to the development of this therapy, which should assist our ambitions to be amongst the first companies in the world to provide a proprietary psychedelic therapy to  the  public,” he said.

“We  look  forward  to  providing  a  further  update  to  our  stakeholders  following the recommendations from the DSMB.”

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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