Month: April 2021

The company is moving from strength to strength as it builds out its drug development pathway for the lucrative US market.

Pharmaceutical cannabis and psychedelic company Incannex Healthcare (ASX:IHL) is coming off a busy quarter as it executes on its multi-channel drug development pathway.

The company currently has programs underway with the US Food & Drug Administration for six different medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies.

And as its 4C filing for the March quarter highlighted, the IHL management team continues to build strong momentum across the portfolio.

Investors responded to the update, sending IHL shares higher again in morning trade to 30.5c – a doubling of the share price since January.

Clinical pathway

Those gains reflect IHL’s ability to advance each of its treatment options with US health regulators, as it builds towards clinically-backed cannabinoid solutions and positions to be ‘the next GW Pharma’.

Among its key developments in the quarter, IHL highlighted advances in its Phase 2 clinical trial to assess the safety and efficacy of its psilocybin-assisted psychotherapy in the treatment of Generalised Anxiety Disorder.

The trial – a world-first — will be carried out as a randomised double-blind active-placebo-controlled procedure, and follows a partnership agreement with a leading research team at Monash University led by Dr Paul Liknaitzky.

Demonstrating the potential of the sector, two psilocybin research programs for depression have received Breakthrough Designation from the FDA.

IHL has now engaged US-based Camargo Pharmaceuticals LLC to work with Incannex and Monash to compile a pre-Investigational New Drug (‘PIND’) application to put to US health regulators.

Elsewhere, IHL has already completed a successful PIND meeting with the FDA for its IHL-675 treatment – a multi-use pharmaceutical drug which combines cannabidiol (CBD) and hydroxychloroquine.

During the quarter, IHL received multiple sets of positive results from multiple in vivo studies using animal models that demonstrated the application of IHL-675 in the treatment of three distinct conditions:

• Lung inflammation – including acute respiratory distress syndrome (ARDS) and sepsis associated ARDS (SAARDS), COPD, asthma, and bronchitis,
• inflammatory bowel disease, and
• rheumatoid arthritis

IHL is now in the process of developing Phase I in-human clinical trials for the purpose of developing three distinct investigational new drug applications (INDs), with a potential addressable market across the space of more than $US100bn.

In addition, the company also advanced the Phase 2 Clinical Trial for its IHL-42X drug used in the treatment of Obstructive Sleep Apnoea (OSA).

“The primary endpoint under observation is the reduction in Apnoea Hypopnea Index (‘AHI’), compared to baseline, or pre-treatment, levels and the trial is being performed at the Alfred Hospital under the supervision of experienced principal investigator Professor Terry O’Brien,” IHL said.

OSA affects more than 30m people each year in the US alone, and is also classified as an addressable market of more than $US100bn for successful treatment options.

“There is currently no pharmacological product available for its treatment,” IHL said.

“Therefore, the board of directors considers that positive results from the trial will be a major value driver for the company.”

Rounding out its multi-channel product development, the company highlighted an extensive in vivo study being carried out by the Monash University Trauma Group at the Department of Neuroscience, where its IHL-216A treatment is being assessed in a model of traumatic brain injury developed by US NFL.

US listing

With an extensive pipeline of product development channels targeting unmet medical needs in the major US market, IHL also reiterated its potential capacity to seek a listing on US capital markets, which it began investigating in February.

The move was in response to “increasing investor interest in both cannabinoid-based pharmaceuticals and psychedelic therapeutic endeavours in North America”, the company said.

In that context, IHL has commissioned US-based EAS Advisors LLC to facilitate introductions to US banks and institutions “with the intention to list on a US main market, whilst simultaneously retaining its ASX listing”, the company said.

As the company’s operating momentum moves from strength to strength, IHL finished the quarter with $10.4m cash in the bank, and remains well-capitalised to advance its multi-channel development pathway for the lucrative US market.

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.

The post Incannex highlights Q1 momentum with 4C update, shares rally again appeared first on Stockhead.

The US cannabis market reacted in jubilation last week, after the Secure and Fair Enforcement (SAFE) Banking Act — which would make it legal for insurers and banks to work with the cannabis industry — was successfully passed by the House of Representatives.

Meanwhile, the recent influx of states electing to legalise cannabis prompted analysts at the investment firm Cowen Inc to revise their annual market forecast for the US recreational market to $41 billion by 2025.

In an interview with The Street, Cowen senior analyst Viven Azer stated that the company had also identified Green Thumb Industries (CSE:GTII) as its “top pick” for the North American sector.

“They are one of [only] ten cannabis license holders in New York, which is poised to be a multi-billion dollar market. We think that Green Thumb has a really nice geographic mix and an attractive profitability margin,” Azer said.

“They are not the largest operator in the space in terms of the number of doors (places where the brand retails), but they do have a healthy geographic mix operating across a dozen states, and they have a solid EBITDA margin.”

The news also marked the beginning of a rally for the Horizons Marijuana Life Sciences Index ETF (HMMJ), which saw its stock reach 10.76 by close of trading Friday. At the same time, the S&P 500 managed to record an increase of 20.63% on this six-month performance chart, while Australia’s All Ordinaries saw a gain of 14.66%.

Conversely, the Australian Cannabis Index continued to underperform again last week, as investors directed their attention towards the booming US Cannabis Market, although it is still showing a 2.86% improvement on its November 2020 outlook.

The Australian pharmaceutical developer Incannex Healthcare (ASX:IHL) also saw its share price climb last week, after the company announced that it will be assessing the potential of its IHL-675A formulation to be classified as a “multi-use drug”.

The change was made in response to recommendations from the US Food and Drug Administration (FDA), which recently met with Incannex to discuss the regulatory pathway that IHL-675A will need to navigate to gain access to the American market.

“The combined annual global market size of the indications being targeted by Incannex with IHL-675A is over US$125 billion so we consider the economic potential, as well as the benefit to patients over incumbent treatments, to be enormous,” Incannex CEO and managing director Joel Latham said.

The Green Fund’s Australian Cannabis Index allows investors to benchmark top players in the Aussie cannabis space against the S&P500, the AORD, and HMMJ, giving them an overview of the health of the industry Down Under.

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Incannex provides investors the best of breed for medicinal cannabis and psychedelic therapy development – and they’re looking at an excursion to the USA

For Incannex Healthcare (ASX:IHL) CEO Joel Latham, 2021 is shaping up as a big year as IHL builds upon clinical backing for six different proprietary treatments and works on a US listing.

Latham caught up with Stockhead this week to discuss the near-term outlook, as well as IHL’s longer-term goals around clinical approval for medical cannabis – a strategy pursued with success by GW Pharma. He also gives us some insight on their psychedelic medicine partnership and clinical trial with Monash University.

Biotech readers would be familiar with the UK-based company GW Pharma, which became the first business globally to get FDA approval for a clinically proven cannabinoid treatment.

Following the in-market success of its Epidiolex product, GW Pharma was acquired this year by the Nasdaq-listed Jazz Pharmaceuticals in a $US7.2 billion deal.

Multiple pathways and diversified asset base

While GW Pharma was successful with a sole product, Latham said IHL’s value proposition is based on a multi-channel approach.

The company has six different treatments in various stages of clinical development – five for IHL’s range of proprietary cannabinoid combination drugs, plus a separate study (in conjunction with Monash University) using the psychedelic compound psilocybin.

Just as GW Pharma did, IHL is targeting unmet medical conditions which means it qualifies for fast-tracked regulatory approval with the US FDA.

And Incannex benefits from that accelerated pathway for six treatments, not just one.

“One characteristic that sets us apart is that we have six programs running in parallel, knowing they all qualify for the accelerated 505(b)(2) commercialisation pathway with the FDA. This affords us the opportunity to achieve new drug registrations in a significantly shorter period of time,” Latham said.

“The company has completed rigorous due-diligence, pre-clinical studies and examined extensive pre-existing data to de-risk our projects for our shareholders. And, as we’ve previously announced, we are also looking at another psychedelic medicine program, which would take our project count to seven in total”.

Addressable market

While the development of multiple drug treatments de-risks IHL’s pathways to clinical approval, it’s also potentially more lucrative.

Latham said that across the six proprietary development programs, the total addressable market is in excess of $US130 billion per annum, where there are currently no existing pharmaceutical therapies available.

“As we continue to experience research success and implement our commercialisation strategy for each drug asset, the company will be providing pharmaceutical treatment options to global markets in excess of $US130 billion on an annual basis,” Latham said.

And with so many projects underway, IHL is looking forward to presenting a steady flow of market updates for the foreseeable future, he added.

“Some programs are at different stages of the clinical development pathway,” he said.

As an example, IHL’s Phase 2 trial to assess the safety and efficacy of its IHL-42X sleep apnoea treatment is underway right now.

“With a partnership in place with The Alfred Hospital, our IHL-42X OSA Phase 2 study is underway with patient dosing taking place. Additionally, we are in the process of assessing the pre-clinical results we’re received our various other development programs and the company will continue to build robust clinical development programs delivering near- and long-term value for shareholders,” Latham said.

US opportunity

Having gained accelerated development pathway eligibility for each of its drug formulations in the US market, IHL is now looking to leverage that traction by exploring opportunities for a US listing – specifically the NYSE or Nasdaq.

And Latham said the basis for those talks progressing is the fact that IHL’s development model is viewed favourably by US investors.

“The feedback we have received from the US market and investment banks is that they see Incannex as a unique value proposition, particularly when looking at comparable companies in the US market, which are valued at over $US1 billion,” Latham said.

He cited the example of two North American clinical psychedelic research companies – Compass Pathways and MindMed – both of which already have a market cap of more than $US1bn.

Mindmed received its pre-IND feedback from the FDA for its proposed Phase 2 trial for LSD and anxiety in December 2020. IHL isn’t far behind as it’s in the process of compiling its own FDA pre-IND meeting package for a Phase 2 trial using psilocybin in patients with generalised anxiety disorder.

“For us, looking to list on a US main market is really about taking advantage of a global pool of investors who are interested in what we’re doing and to expand upon our ASX listing by attracting sophisticated investors globally,” Latham said.

Ultimately, the company’s standing in the psychedelic and cannabinoid research space is the “truly appreciated value driver” behind IHL, he added.

“We have secured IP protection, created and implemented a robust FDA regulatory strategy and US investors are starting to understand the upside potential of Incannex, simply due to targeting unmet medical conditions providing the company with significant commercial opportunity.”

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.

The post How Incannex is positioning to be the ‘next GW Pharma’, with CEO Joel Latham appeared first on Stockhead.

Pharmaceutical cannabis and psychedelic medicine company Incannex Healthcare (ASX:IHL) continues to execute on its multi-channel development pathway for clinically-proven cannabinoid treatments.

And the company announced some more good news this morning, after holding its Pre-Investigational New Drug Application meeting (PIND) with the US Food and Drug Administration (FDA).

Following those discussions, IHL announced today that it will “expand its development program to assess the potential for IHL-675A to become a multi-use pharmaceutical drug applicable to the treatment of patients with lung inflammation, inflammatory bowel disease (IBD) and rheumatoid arthritis”.

The FDA also confirmed that marketing applications for IHL-675 should be done using the 505(b)(2) application process – a less costly and more streamlined development pathway than the traditional 505(b)(1) path.

CEO Joel Latham said the IHL board is “delighted with the positive feedback and encouragement from the FDA”, allowing the company to “now move forward with conviction on our clinical programs”.

The update marks another step forward for the company, following a steady stream of positive developments (and the addition of a psychedelic project with Monash University) which has seen IHL shares rise by more than 500pc since September.

IHL-675 development pathway

Ahead of Incannex’s PIND meeting with the FDA, the company had already obtained positive pre-clinical results for five separate in-vivo assessments of IHL-675, in the treatment of various types of inflammation.

As part of that process, the following indications have been prioritised for clinical assessment:

• Acute respiratory distress syndrome (ARDS) and sepsis associated ARDS (SAARDS);
• pulmonary neutrophilia (the primary underlying cause of COPD, asthma, and bronchitis);
• inflammatory bowel disease, and;
• rheumatoid arthritis.

Following its meeting with the FDA, Incannex will now move development for two treatments – ARDS/SAARDS and pulmonary neutrophilia – into a combined research program and Investigational New Drug (IND).

Inflammatory bowel disease and rheumatoid arthritis will have their own research programs and INDs

Incannex says that the three development programs has increased the scope and economic potential of the program.

Application process

Along with its approval for an expanded development pathway, the FDA also advised that IHL’s marketing applications for IHL-675A should be done using 505(b)(2) New Drug Application pathway.

The 505(b)(2) provides guidance for how safety and efficacy information on active ingredients can be approved by historical studies – rather than having to be conducted by Incannex.

The ruling gives Incannex a “less costly and faster route to approval” compared to 505(b)(1) pathway, IHL said, whilst also “creating a new and differentiated commercial product, subject to clinical success”.

“Additionally, the FDA panel provided valuable guidance on the design of clinical trials, including opinions on the selection of clinical trial endpoints,” IHL said.

Latham highlighted that with the results from its PIND meeting, IHL continues to build momentum for its proprietary treatments for what is a major market opportunity.

“The combined annual global market size of the indications being targeted by Incannex with IHL-675A is over US$125 billion,” Latham said.

“So we consider the economic potential — as well as the benefit to patients over incumbent treatments — to be enormous.”

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.

The post Incannex gets more good news, as FDA approves expanded development pathway for its IHL-675 treatment appeared first on Stockhead.