Incannex Healthcare Limited (ASX: IHL) has engaged pharmaceutical manufacturing company Procaps S.A to develop and manufacture soft gel capsules of Incannex’s cannabis medicine IHL-42X.
The agreement between the two companies will see Procaps making IHL-42X for Incannex’s Phase 2, Phase 3, and open-label clinical trials. If these trials are successful and IHL-42X is approved for the market, Procaps will also make IHL-42X for patients.
Incannex’s new trials will use IHL-42X to treat sleep apnea – a condition that sees people’s upper airway narrowing as they sleep. According to an article from the Lancet, sleep apnea affects 936 million adults globally. People who have it often use CPAP machines, but these don’t work for everyone (as they can be uncomfortable and claustrophobic). If IHL-42X proves effective, it could be the world’s first sleep apnea drug, as there are currently no registered drugs available for sleep apnea.
According to Incannex’s CEO and Managing Director Mr Joel Latham, the company’s partnership with Procaps will help produce “the best possible product”, as Procaps is one of the world’s top three companies for soft-gel drug manufacturing. Procaps’ manufacturing plant is also GMP approved by Australia’s Therapeutic Goods Administration (TGA), among other regulatory bodies.
Partnering with Procaps will help us formulate the best possible product for IHL-42X. Procaps will supply our clinical trial programs but can also quickly ramp up production for commercial supply upon successful clinical trial outcomes.
The agreement between Incannex and Procaps has already begun and will continue until the end of Incannex’s trials. Incannex is currently up to the Phase 2 trial, which is using the Apnea-Hypopnea Index (AHI), the Epworth Sleepiness Scale (ESS), the Oxygen Desaturation Index (ODI) and the Profile of Mood States (POMS) rating scale to test IHL-42X. The company expects results from this trial in early 2022 and will continue with its work with IHL-42X after that.