The June quarter demonstrated IHL’s ability to execute on a multi-channel development strategy.
For medicinal cannabinoid and psychedelic pharmaceutical company Incannex Healthcare (ASX:IHL), Q4 marked a busy quarter as it made a number of key research advancements across its multi-channel product suite.
And in its quarterly filing this morning, the company highlighted the latest developments as it pursues six different US Food and Drug Administration programs for cannabinoid pharmaceutical products and psychedelic medicine therapies.
Psilocybin treatment
Among IHL’s treatment studies is its “Psi-GAD” combination therapy that incorporates the use of psilocybin to treat generalised anxiety disorder.
Working with experts at Monash University, Incannex finalised the clinical trial protocol for Psi-GAD in Q4, with input from a number of leading researchers.
Incannex “is now in the process of co-ordinating two clinical trials as part of the clinical development program aimed at achieving FDA approval for Psi-GAD therapy”, the company said.
The first Phase 2 study will include 72 patients to test the efficacy of Psi-GAD over a 10-week period. Data from that study will then go towards the development of Phase 2b trials, where planning has now commenced.
“Preparations for this larger, pivotal, multi-site phase 2b clinical trial are continuing and a FDA pre-investigational new drug application (‘pre-IND’) data package and meeting request has progressed during the quarter,” Incannex said.
The recruitment of therapists for both trials has commenced, with therapist training expected to start before the end of the December quarter.
Pharmaceutical Cannabinoid-based treatments
Incannex has also provided detailed information to the market throughout the June quarter on product development for its clinically backed suite of combination CBD treatments:
IHL-42X for obstructive sleep apnoea;
IHL-675A for lung inflammation, rheumatoid arthritis, and inflammatory bowel disease; and
IHL-216A for concussion and traumatic brain injuries.
Patient recruitment and dosing at the University of Western Australia is ongoing as part of IHL’s phase 2b dose-finding crossover clinical trial, to investigate the effect of IHL-42X for patients with sleep apnoea.
Results of the trial, which also incorporates the Prince Alfred Hospital in Melbourne, are anticipated by the end of the December quarter.
Importantly, some preliminary results from the trial were included by IHL as part of its International Patent Application called “Methods for the treatment of obstructive sleep apnoea”, which the company submitted in July.
The filing of the patent “secures the filing date of the application and the claims within it”, and gives IHL an opportunity to secure patent protection in major global markets such as the US, Europe and Japan.
Following pre-IND discussions with the US FDA, Incannex has also expanded the development program for its IHL-675A treatment to become a “multi-use pharmaceutical drug applicable to inflammatory lung conditions (COPD, asthma, ARDS, and bronchitis), rheumatoid arthritis and inflammatory bowel disease”, the company said.
Phase 1 clinical trials to assess the safety of soft-gel IHL-675A capsules are now underway.
The soft gel capsules are manufactured by Procaps S.A., a GMP-compliant manufacturer that can quickly ramp up production to commercial quantities if and when required.
“Subject to clinical success, the results of this clinical trial will form part of three FDA investigational new drug (IND) applications for each of the three indications,” Incannex said.
“Once the IND applications are evaluated and approved, the company intends to conduct phase 2 and 3 clinical trials partly or wholly in the United States.”
Rounding out IHL’s Q4 development updates, the company’s IHL-216A treatment is a combination drug that combines CBD with an anaesthetic agent, such as isoflurane, with an inhaler-based delivery method.
During the quarter, the company engaged leading contract development and manufacturing organisation company Vectura to develop the specific formulation of IHL-216A for use in clinical trials.
The commissioning of Vectura follows on from an extensive in vivo study to assess the protective effect of IHL-216A in sports concussions, carried out with leading researchers at the Monash University Department of Neuroscience.
The treatment has been designed to comply with regulations stipulated by both the World Anti-doping Authority and Australian Anti-Doping Authority’s, and has the potential to serve a major addressable global market for health complications and deaths caused by concussion.
Working with Vectura, Incannex said the development and formulation of IHL-216A will occur in parallel with its ongoing in vivo studies with Monash.
The development work will allow IHL to complete the delivery mechanism required “for advancement of pivotal clinical trials once the in vivo study is finalised”, the company said.
Taken in aggregate, the June quarter demonstrated the ability of IHL’s management team to execute on its multi-channel clinical development pathway.
Heading into 2022, the IHL’s extensive work with both leading researchers and global health regulators leave it well placed to move its product suite towards commercialisation, as it looks to capitalise on a multi-billion-dollar addressable market 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.
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