Cannabinoid and psychedelic biotech company Incannex Healthcare (ASX: IHL) has engaged pharmaceuticals manufacturer Procaps SA to develop a soft gel capsule form of its IHL-42X cannabinoid drug for the treatment of obstructive sleep apnoea.
The pharmaceutical-grade capsules will be used for Incannex’s phase 2, phase 3 and open label clinical trials of IHL-42X.
Development will be supported by Procaps’ intellectual property portfolio which provides access to a range of proprietary formulation and manufacturing techniques for the finished product, including its patented Unigel technology for encapsulating solid dosage forms within capsules.
Incannex managing director Joel Latham said he was pleased to be partnering with a “sophisticated pharmaceutical company” capable of supplying clinical trials and quickly ramping up production for commercial supply.
Phase 2 trial
Incannex is currently completing a proof-of-concept phase 2 clinical trial to assess IHL-42X, which comprises a combination of dronabinol (a man-made form of tetrahydrocannabinol) and acetazolamide.
The primary endpoint of the trial is a reduction in the apnea hypopnea index (AHI), while secondary endpoints include a reduction in the oxygen desaturation index (ODI), lowering daytime somnolence measured by the Epworth Sleepiness Scale (ESS) and an improvement in mood as measured by Profile of Mood States (POMS) rating scale.
Patient dosing is expected to be finalised before year end and results will be used to support an investigational new drug application with the US Food and Drug Administration (FDA).
Results will also be used to inform the design of subsequent clinical trials.
In July 2021, a confidential interim analysis was performed on data from the clinical trial and the data was used to support a patent application regarding methods for the treatment of obstructive sleep apnoea.
Incannex has also commenced a six-month open label extension to the phase 2 trial, which seeks to re-assess the therapeutic benefit and tolerability of IHL-42X in people who have previously benefited from the drug in trials.
There is currently no registered drug remedy for sleep apnoea. The CPAP device is often prescribed however can be cumbersome, intrusive and disruptive for partners. Patient compliance to the CPAP is also low so a successful pill form treatment may well be revolutionary for this condition.
Top three ranking
Procaps is the largest integrated contract development and manufacturing company in Latin America and is ranked within the top three companies globally for soft gel manufacturing capacity.
It has developed over 500 formulations for pharmaceutical and nutritional products and reached over 50 markets globally.
The company’s manufacturing plant has been approved for good manufacturing practices (GMP) by organisations including the FDA, Australia’s Therapeutic Goods Administration, Health Canada and the UK’s Medicines and Healthcare Products Regulatory Agency.