Incannex Healthcare advances cannabinoid and psychedelic medical therapies

Incannex Healthcare (ASX: IHL) has made several advances across its portfolio of cannabinoid and psychedelic medical therapies, including generating positive preliminary safety and tolerability results of its anti-inflammatory drug IHL-675A during a phase 1 trial.

IHL-675A is a fixed dose combination of cannabidiol (CBD) and hydroxychloroquine (HCQ) and has been designed to treat rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

In in vivo models of these diseases, IHL-675A outperformed either CBD or HCQ alone.

The phase 1 clinical trial kicked-off in August with preliminary results revealed earlier this month.

Three cohorts of 12 participants were recruited for the trial and received either IHL-675A, CBD or HCQ.

The trial measured the safety, tolerability and pharmacokinetic profiles of the three treatments and IHL-675A was found to be “well-tolerated” with no serious adverse events.

With positive phase 1 data under its belt, Incannex has begun planning a phase 2 study with this to initially evaluate IHL-675A in rheumatoid arthritis sufferers. The company will also undertake phase 2 trials of the drug in inflammatory bowel disease and lung inflammation patients.

Advancing IHL-216A

Incannex also progressed its drug IHL-216A during the September quarter.

IHL-216A is a CBD-based drug that was developed to be inhaled to treat concussion and traumatic brain injury (TBI).

In advancing IHL-216A, Incannex engaged Curia Global to produce the drug to current Good Manufacturing Practice (cGMP) standards.

Data is also being gathered on IHL-216A quality and stability to underpin future regulatory filings.

A pre-investigational new drug (IND) meeting package for the drug was submitted with the US Food and Drug Administration in August and this resulted in a “constructive” pre-IND meeting earlier this month.

The FDA provided “valuable, multidisciplinary feedback” on the proposed development of IHL-216A, while also recognising there is a “significant unmet medical need” for treating TBI.

IHL-42X

Also under development is Incannex’s IHL-42X drug, which has been designed to treat obstructive sleep apnoea (OSA).

Positive results from a phase 2 trial using IHL-42X in OSA sufferers were revealed in June.

“Importantly, IHL-42X was well tolerated with low dose IHL-42X observed to have a lower number of total treatment emergent adverse events than placebo,” the company stated.

Incannex says the trial was a “major success” and “step forward” – providing confidence for further assessment in studies necessary for drug registration.

During the September period, Incannex progressed plans to open an IND with the FDA, with an update on this drug’s progress expected in the current quarter.

APIRx Pharmaceuticals acquisition

In relation to its acquisition of APIRx Pharmaceuticals, Incannex’s scientific advisory team has been arranging the manufacture of high-priority drugs within the portfolio.

APIRx has 22 clinical and pre-clinical research and development projects, along with intellectual property comprising 19 granted patents and 23 under application.

Incannex is initially prioritising APIRx’s drug candidates: MedChew Dronabinol (for chemotherapy induced nausea); MedChew Rx (for pain and spasticity in multiple sclerosis sufferers); CanQuit and CanQuitO (combined nicotine and CBD for smoking cessation and opioid addiction, respectively); CheWell (high-bioavailability chewable tablet for treating adolescent drug addiction); CanChew (high-bioavailability and long-acting CBD gum for the over-the-counter market); and Renecann (topical CBD for various skin diseases).

Psychedelic therapies

Incannex also progressed its psychedelic therapies during the September quarter.

A phase 2 trial continued during the period, which was evaluating a combination of psilocybin and specialised psychotherapy sessions for treating generalised anxiety disorder.

Dr Paul Liknaitzky is leading the trial at Melbourne’s Monash University.

Roughly 30 patients are expected to complete the study during the current quarter, with preliminary data expected early next year.

“Also, during the September quarter, Incannex advanced negotiations with Monash University over a new psychedelic treatment paradigm for severe forms of one or more anxiety disorders,” Incannex noted.

Dr Liknaitzky will lead this trial, which will combine virtual reality exposure response therapy with psychedelics.

This trial will assess efficacy, safety, tolerability and optimal dose.

FDA regulatory affairs expert

To strengthen its efforts with securing FDA approvals, Incannex appointed Robert Clark to its board during the September quarter.

According to Incannex, Mr Clark is an internationally recognised expert in liaising with the FDA and European Medicines Agency.

He is also well-versed in US pharmaceutical advertising and regulatory aspects relating to healthcare professionals and sales force activities.

Mr Clark’s previous experience includes 20 years with Pfizer and 10 years with Novo Nordisk.