Fortrea To Manage Incannex's FDA IND Opening Phase 2/3 Trial Of Its Dronabinol-Based Drug For Obstructive Sleep Apnea

Incannex Healthcare Limited IXHL IHL has engaged Fortrea FTRE as the contract research organisation for management of the IND opening phase 2/3 clinical trial investigating IHL-42X for treatment of obstructive sleep apnea (OSA).

The phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X at the best performing two doses from the proof-of-concept clinical trial, in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure, over a 52-week treatment period. Participants will receive one of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the study. All participants will complete daily surveys on their sleep quality, attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy. Every three months, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ Apopnea Hypopnea Index score (‘AHI’). All drug treatments will be compared to placebo.

CEO and managing director of Incannex, Joel Latham stated, “The initial phase 2 proof of concept clinical trial over IHL-42X demonstrated an average reduction in our primary end point, AHI of 50.7%, with 25% of subjects having a reduced AHI of >80%. Importantly, we also observed a reduction in average patient oxygen desaturation index of 59.7%, markedly improved sleep quality and a reduction in cardiovascular stress. These results were truly remarkable and now allows for this phase 2/3 trial to be a genuine long-term safety and efficacy trial. If we again observe such remarkable drug efficacy, safely administered over the 52 weeks, Incannex is confident that our product will be marketable.”

Photo: Benzinga edit with photos by geralt and lindsayfox on Pixabay

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