Author: incannex@admin

Incannex is teaming with Eurofins to help people with opioid and nicotine addiction disorders, by undertaking formulation development and manufacture of CannQuit-N and CannQuit-O.

Incannex Healthcare (ASX:IHL) has engaged multinational contract development and manufacturing  organisation Eurofins Scientific (Eurofins) to manufacture its two distinct medicated chewable products designed to treat nicotine and opioid addiction disorders.

The CannQuit products are combination drug assets with associated granted patents and patent applications that were transferred to IHL following the acquisition of APIRx Pharmaceuticals, completed in August 2022.

Eurofins, through its subsidiaries, is a world leader in pharmaceutical contract  research  services.

It is also one of the global independent market leaders in in the support of clinical studies, as well as in BioPharma contract development and manufacturing.

Eurofins will undertake formulation development and manufacture of CannQuit Nicotine (CannQuit-N) and CannQuit Opioid (CannQuit-O).

CannQuit-N combines nicotine and cannabidiol (CBD) within a controlled-release, functional, medicated chewing gum.

CannQuit-O combines CBD and an off-patent prescription opioid antagonist, and/or partial agonist-antagonist within the formulation.

Data collected vital for regulatory packages

The cGMP grade products manufactured by Eurofins will be used in clinical trials designed to assess the safety and efficacy of the CannQuit products for smoking cessation and the treatment of opioid addiction.

Data collected on quality and stability of the CannQuit anti-addiction products during the development and manufacturing of the two drug candidates at Eurofins will be key components of future regulatory packages.

These data packages include investigational new drug (IND) applications and new drug application (NDA) filings with the US Food and Drug Administration (FDA).

Medicated chewing gums deliver their active ingredients directly into the circulation of the oral mucosa, ensuring that the effects of the ingredients are delivered rapidly, but also in a sustained manner to reduce cravings for longer than other delivery methods.

Rapid onset and sustained effect are both qualities desirable for the treatment of addiction disorders.

Furthermore, the act of chewing, known as mastication, also has a multi-action, anti-anxiety effect that has been demonstrated in other scientific assessments.

IHL chief scientific officer Dr Mark Bleackley said opioid and nicotine addiction are significant health problems and a major burden on health systems throughout the world.

“CannQuit products are designed to improve established therapies for the treatment of addiction,” he said.

“They do this by adding CBD, which is known to reduce cravings and anxiety which is critical for breaking the addiction cycle”.

US opioid epidemic

The opioid epidemic has reached critical levels in the US and the industrialised world. Fatal opioid overdoses and opioid use disorder cost the US more than $1 trillion in 2017, as measured by the Centre for Disease Control (CDC) in the journal Drug and Alcohol Dependence. It 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.

Cigarette smoking and nicotine addiction

Cigarette smoking remains a leading cause of preventable death in the US, where it is responsible for more than 480,000 deaths annually, including nearly 42,000 deaths from second-hand smoke exposure.

The total economic cost of smoking in the US is estimated at more than US$300 billion annually, including nearly US$170 billion in direct medical care for adults and more than $156 billion in lost productivity.

Nicotine chewing gum is already a long-standing and accepted product throughout the globe with annual sales amounting to $US5.2 billlion in 2020, however, the progression to complete smoking cessation is limited.

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

The patented technology of controlled and sustained release of the active ingredients also is believed to improve the therapeutic value of this novel drug candidate.

Nicotine replacement therapy by CBD has a solid pre-clinical basis and encourages IHL to further develop and investigate CannQuit-N in human clinical trials.

CBD has been found to inhibit the α7 nicotinic acetylcholine receptor which plays a role in the reinforcing effects of nicotine.

Interactions of endocannabinoids with the CB1 receptor are essential in mediating behaviours associated with addiction and there are preliminary clinical observations suggesting that CBD may help to reduce the number of cigarettes smoked in a day.

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 Healthcare commits to a 116-person bioavailability/ bioequivalence (BA/BE) study and will submit an investigational new drug application to FDA.

Incannex Healthcare (ASX:IHL) will assess the pharmacokinetics and tolerability of the two key active pharmaceutical ingredients (APIs) in IHL-42X compared to their respective US Food and Drug Administration (FDA) reference listed drugs.

Incannex hopes to achieve the first ever registered pharmaceutical product on the market for sleep apnoea.  It hopes to displace the current treatment standard, which is the mechanical CPAP device that has a considerable market size of US$10B per annum – but is associated with poor patient compliance due to discomfort.

The BA/BE study being undertaken in South Australia will, amongst other things, look at the effect of food on the pharmacokinetics of IHL-42X and include 116 participants who will each complete multiple treatment periods.

Study results to form critical component of NDA

The design of the BA/BE study is consistent with FDA recommendations and specific advice received by IHL in its pre-IND meeting with the FDA. Subject to ongoing clinical success, the results from the study will form a critical component of a future new drug application by providing a necessary bridge to IHL-42X’s reference listed drugs, thereby facilitating the use of certain historical data.

IHL prepares for Phase 2/3 trials for OSA

The cannabinoid and psychedelics pharmaceutical company also stated that it is targeting submission of an Investigation New Drug (IND) application with the US Food and Drug Administration (FDA) in Q1 2023.

An IND application is a comprehensive information document detailing safety, efficacy, and quality of IHL-42X and is needed before holding clinical trials at treatment sites in the US.

Once opened, the IND it is continuously updated with research and development results for the purpose of ongoing assessment by the FDA.

IHL aims to submit the IND application in Q1 2023, followed by commencement of pivotal, multi-site, Phase 2/3 clinical trials..

Feasibility Studies for multiple trial sites – completed

In preparation for the Phase 2/3 clinical trials, IHL has undertaken a 12-week feasibility study whereby the trial design was provided to potential investigators along with a survey to gauge interest in conducting the study and identify any region-specific regulatory hurdles.

The feasibility study involved contacting 195 trial sites across 14 countries in North America, Europe, South America, and Australasia. 63 sites expressed interest in conducting the study. IHL anticipates that 20-30 sites will eventually be selected to conduct the clinical trials.

Meanwhile, IHL has completed a Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of its anti-inflammatory IHL-675A. IHL is arranging Phase 2 studies for patients with rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

Incannex is also considerably advanced in a phase 2 clinical trial looking at the use of psilocybin in patients with generalised anxiety disorder. The psychedelic trial is the only of its type in the world and is being done in partnership with Monash University.

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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After completing patient dosing in its Phase 1 clinical trial of anti-inflammatory IHL-675A, Incannex Healthcare has advanced to Phase 2 trials.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has completed the Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of its anti-inflammatory IHL-675A.

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

IHL-675A has been well tolerated, with no adverse event of concern reported to date.

IHL is arranging Phase 2 studies for patients with rheumatoid arthritis.

The company is also planning Phase 2 studies for patients with inflammatory bowel disease and lung inflammation.

IHL is preparing for a pre-IND meeting with the FDA on the development of IHL-675A specifically for the treatment of patients with arthritis.

It intends to open an IND in parallel with the Australian Phase 2 study.

IHL chief scientific officer Dr Mark Bleackley said it was an exciting opportunity for the company to complete dosing in its Phase 1 study for IHL-675A because it has so many potential therapeutic uses.

“At this stage, there have been no unexpected adverse events and the drug appears to be well tolerated,” he said.

“This gives our team the confidence to take the next steps to commence Phase 2 clinical trials, initially in patients with arthritis, then in patients with lung inflammation and inflammatory bowel disease.”

Incannex achieves key FDA milestone

In further good news for the company, IHL earlier this week announced it is on track to advance its inhaled drug product for the treatment of traumatic brain injury and concussion (TBI) with positive vital feedback from the US Food and Drug Administration (FDA).

The company has completed a constructive pre-Investigational New Drug application (pre-IND) meeting with the FDA.

The meeting is for its proprietary drug IHL-216A, which combines cannabidiol (CBD) with any volatile anaesthetic agent, including isoflurane (ISO) for TBI.

IHL submitted a pre-IND meeting package to the FDA in August 2022. The meeting package included a description of the formulation, an overview of the proposed clinical development plan and specific questions on the regulatory requirements for opening an IND.

Opening an IND is required to conduct trials in the US and ensures that trials are designed to meet the data requirements necessary for FDA marketing approval.

In written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need that requires innovative treatment solutions.

The FDA also confirmed that the FDA505(b)2 application was the appropriate regulatory pathway for IHL-216A, whereby some of the information required for marketing approval may derive from studies already completed on the drug components of IHL-216A and in the public domain.

FDA provided critical guidance on the data requirements for opening an IND for IHL-216A, particularly related to the intricacies of developing an inhaled drug product and conducting clinical trials that involve an anaesthetic.

Follow-up now underway

IHL is now drafting a follow-up request for additional information on the FDA’s recommendations.

The pre-IND meeting indicated that the agency is highly interested in the development of IHL-216A for treatment of TBI.

The company said its responses covered all aspects of the proposed development and engaged a range of disciplinary experts that provided useful insight on all aspects of the development plan.

The FDA  has  provided  essential  advice  on  inhaled  drug  development  that  will  guide  the  most  efficient development of IHL-216A.

Positive early results

IHL-216A has demonstrated neuroprotective activity in two separate animal models of traumatic brain injury, one representing moderate to severe injury and the other representing mild injury, or concussion.

In both models, treatment with IHL-216A improved the effects of injury to a greater extent than either CBD or ISO monotherapy.

In May IHL released the results of an extensive animal study that compared IHL-216A to its component drugs, CBD, and ISO, in a model developed in collaboration with the US National Football League (NFL).

In that experiment, IHL-216A was observed to restore spatial memory after 24 hours in injured rodents. Injured rodents that only received the vehicle as treatment did not display restored spatial memory.

IHL is a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.

Transformative year for IHL

These latest achievements come in what has been a year of accomplishments for IHL. In September the company was included in the S&P/ASX300 index and in February made its Nasdaq debut with a dual listing to attract medicinal cannabis investors as it pursues North American growth.

The company acquired leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx), to further strengthens its global position in the cannabinoid and psychedelic sectors.

It also appointed recently appointed former Pfizer and now Novo Nordisk A/S vice president, US regulatory affairs Robert B. Clark to its board as a non-executive director.

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.

The post Incannex jumps another hurdle to advance to Phase 2 clinical trials of its anti-inflammatory drug appeared first on Stockhead.

Incannex Healthcare has been promoted to the big league.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has achieved a milestone with its inclusion in the S&P/ASX300 index.

Inclusion will be effective prior to the open of the ASX on September 19 and follows the index’s second semi-annual rebalance for 2022.

The S&P/ASX 300 measures performance of 300 of the largest, highly liquid securities listed on the ASX by float-adjusted market cap, including large, mid, and small cap components of the S&P/ASX index family

The S&P/ASX 300 is designed to provide investors with broad exposure to the Australian equity market.

The index is liquid and float-adjusted, and it measures up to 300 of Australia’s largest securities by float-adjusted market capitalisation.

It’s important because some investment funds work to emulate the return of various indexes based on the investment mandate of the fund.

Year of growth for IHL

It’s been a transformative year for IHL, which undertook a landmark acquisition of leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx), to further strengthens its global position in the cannabinoid and psychedelic sectors.

The company recently appointed former Pfizer and now Novo Nordisk A/S vice president, US regulatory affairs Robert B. Clark to its board as a non-executive director.

In February IHL went to Wall Street with a dual Nasdaq listing to attract keen medical cannabis investors as it pursued North American growth.

These corporate developments have taken place while Incannex has been advancing studies and trials into numerous conditions including obstructive sleep apnoea rheumatoid arthritis, traumatic brain injury and generalised anxiety disorder.

In June of this year, Incannex reported that its phase 2 clinical trial to assess IHL-42X in patients with sleep apnoea was a success and it is now working on opening an IND with the FDA to continue studies relevant to FDA approval.

Incannex’s phase 2 clinical trial to investigate psychedelic compound psilocybin in patients with generalised anxiety disorder is ongoing with an initial readout of results due before the end of the calander year.

Excited by S&P/ASX300 index listing

IHL CEO and managing director Joel Latham said it was a milestone for the company to be included onto the S&P/ASX300.

“We’re delighted to be recognised for inclusion in the S&P/ASX 300 index to be listed among the largest and most-recognisable companies in Australia,” Latham said.

“Being listed in the index is a precursory investment condition for many domestic and international investment institutions so we are excited for the possibilities this recognition may bring.”

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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Incannex has appointed a former Pfizer and now Novo Nordisk A/S executive to its board to help steer regulatory approvals for its key cannabinoid and psychedelic medicinal therapies.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has appointed international pharmaceutical regulatory heavyweight Robert B. Clark to its board as a non-executive director.

Clark is a senior-level strategic regulatory affairs expert with more than 38 years of US and global regulatory experience in a move the company believes is a vote of confidence in their business.

He worked with global pharmaceutical giant Pfizer (NYSE:PFE) for more than 20 years and was vice president of worldwide regulatory strategy and US regulatory affairs at the company.

Clark led a team of up to 150 regional regulatory professionals supporting drug development.

At Pfizer he led or supported US Food and Drug Administration (FDA) approval of many new medicines and represented the company at critical interactions with FDA, and other global health authorities, including key project milestone meetings.

Clark joined Danish multinational pharmaceutical powerhouse Novo Nordisk A/S (NYSE:NVO, CPH:NOVO-B) in 2012, where he is currently vice president, US regulatory affairs.

Novo Nordisk has a market cap of ~US$185 billion, and is one of the world’s biggest companies.

Clark is an internationally recognised expert on FDA and the European Medicines Agency (EMA) liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities.

At Novo Nordisk, Clark provides strategic leadership to more than 50 regulatory staff and scientists in the development of new medicines. He advises the global executive team on matters related to drug development programs, FDA liaison strategies, managing FDA-related compliance issues, and monitoring emerging US regulatory trends and opportunities.

He and his team manage all interactions with FDA on behalf of Novo Nordisk and have secured FDA approvals for 12 significant new drugs since he started at the company a decade ago.

Proven track record to be applied to ‘medcan’ and psychedelics

Clark has senior level experience in managing regulatory aspects of large-scale pharmaceutical acquisitions, significant compliance matters and business development due diligence.

He has documented success with FDA accelerated approval programs including fast-track, orphan drug, breakthrough therapy designations, and priority reviews, which are areas of interest for IHL management due to the nature of its drug candidate mix.

Clark’s appointment follows IHL’s landmark acquisition of leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx), which further strengthens its global position in the cannabinoid and psychedelic sectors.

Independent validation from a pharmaceutical superstar

IHL CEO and managing director Joel Latham describe Clarke as among the best credentialed regulatory affairs experts globally and said his appointment to the board of directors is a strong vote of confidence in its drug candidates and development strategy.

“He brings to Incannex deep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations,” Latham said.

“His experience will be invaluable to us now that our interactions with FDA have become more frequent whilst we pursue our mission to bring cannabinoid and psychedelic pharmacological solutions to patients with unmet medical needs.”

Clark said he was looking forward to being a part of the burgeoning cannabinoid and psychedelic medicines sector through his IHL appointment.

“I look forward to working with the board and the management team, and I am excited about the broad Incannex portfolio of products to treat patients who have few or no other available treatments,” he said.

“Cannabinoid and psychedelic pharmacotherapies represent a growing area of research and hold the potential to treat various conditions for which effective options are limited.”

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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