Clinical-stage biopharma company Incannex Healthcare Ltd. (NASDAQ:IXHL) shared its quarterly activities report and appendix 4C for the period ended 30 September 2022, noticeably applying for several U.S. FDA approvals regarding its cannabinoid pharmaceutical products and psychedelic medicine therapies.
As for numbers, Incannex’s total cash for the mentioned period was nearly $21.4M (AU$33.4M) while research and development expenses accounted for $1.445M (AU$2.256M). Interestingly, the company is eligible to receive a significant federal annual cash rebate, consisting of approx. 43.5% of the total investment made on R&D in Australia.
In another set of events, in September of 2022 Incannex was included in the Standard and Poor’s (S&P)/ ASX 300 liquid and float-adjusted Index by Dow Jones, designed to provide investors with broader exposure to the Australian equity market and address their needs to benchmark against a broad opportunity set characterized by sufficient size and liquidity.
Importantly, being listed in the index is a precursory investment condition for many domestic and international investment institutions.
Regarding business highlights, the company’s Phase 1 clinical trial of the anti-inflammatory combination cannabinoid drug IHL-675A showed positive preliminary results as to safety, tolerability and pharmacokinetic profile, and is setting up the organization for Phase 2 clinical studies testing the compound on patients with rheumatoid arthritis.
The potentially multi-use compound is made from cannabidiol (CBD) and hydroxychloroquine (HCQ) in a fixed-dose combination. IHL-675A has outperformed CBD and HCQ in various pre-clinical models of inflammation, including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation.
Another development is the scale-up cGMP manufacturing of IHL-216A, Incannex’s proprietary inhaled drug product for concussions and traumatic brain injuries with partner Curia Global Inc.
Incannex also enrolled in a constructive pre-Investigational New Drug Application meeting with the FDA on a previously submitted package corresponding to IHL-216A, including a description of its formulation and an overview of the proposed clinical development plan.
The company has also advanced its IND-enabling clinical trial for IHL-42X. Recently, its Phase 2 clinical trial for patients with obstructive sleep apnea (OSA) provided positive results, particularly showing that a low dose of IHL-42X is safer and more efficacious than mid and high doses.
Furthermore, during the quarter Incannex fully acquired APIRx Pharmaceuticals USA LLC, adding 22 clinical and pre-clinical research and development projects representing aggregate addressable markets of approx. annual $400B to its drug portfolio -which already included 19 granted patents and 23 pending patents.
The initial high-priority former APIRx drug candidates are MedChew Dronabinol for chemotherapy-induced nausea and vomiting, MedChew Rx for pain and spasticity in patients with multiple sclerosis, chewables CanQuit and CanQuitO with nicotine and cannabinoids or cannabinoids and opioid antagonists for smoking cessation and opioid addiction, CheWell for teen drug addiction studies, the CanChew patented high-bioavailability and long-acting CBD chewing gum for the OTC market, and topical cannabinoid development candidates for various skin diseases (Renecann.)
Also during the quarter, Incannex added the FDA regulatory affairs expert Robert B. Clark to its board of directors. Clark believes that cannabinoid and psychedelic pharmacotherapies “represent a growing area of research and hold the potential to treat various conditions for which effective options are limited.”
As for psychedelics, Incannex and partner Monash University continue with the advancement of the Phase 2a clinical trial of psilocybin and psychotherapy for Generalized Anxiety Disorder (GAD) and both are in advanced negotiations regarding a new psychedelic treatment paradigm for severe forms of anxiety disorders including virtual reality and exposure-response therapy (ERP) combined with psychedelics.
Meet The New Australian Eating Disorders Research & Translation Centre Working With Psilocybin Mushrooms
Magic -or psilocybin- mushrooms are currently being studied for their potential efficacy on the treatment of several eating disorders. And that is what the new -and first of its kind- Australian center has set itself to do.
Noticeably, the new facility has received an initial considerable endorsement on behalf of the federal government: an $8.338.200 (AU$13 million) investment over four years, in view of the almost 1.2 million people living with an eating disorder in the country.
The center’s director, Dr. Sarah Maguire, said that anorexia has been confirmed to be one of the most lethal mental illnesses, and believes that research has to focus on trying to change. Particularly, she believes insufficient research and funding have been affected by the still ongoing stigma and beliefs that eating disorders are self-induced or part of a 'lifestyle'.
"They are not about the 'thin ideal', they're not about food ... that's how they present but the complexity and the reason they develop and the lived experience of the person who has it are entirely different from that," Dr. Maguire explained.
One of the center’s most interesting moves is the incorporation of a diversity of voices, recruiting First Nations representatives and people with a personal experience with eating disorders.
Researcher Claire Finkelstein explained that the prevalence of eating disorders more than doubled by the end of the pandemic, which is precisely why funding, treatment options and making treatment more accessible for everybody is so important.
Photo by David Clode on Unsplash
