Incannex Healthcare Inc. (NASDAQ:IXHL) shares jumped 10% after the company announced encouraging Phase 2 trial results for its experimental sleep apnea treatment, IHL-42X.
According to topline data from the RePOSA trial, the investigational oral therapy produced statistically significant improvements on several major endpoints for obstructive sleep apnea (OSA). In particular, IHL-42X reduced the Apnoea-Hypopnoea Index (AHI) by up to 83% from baseline when compared to placebo. Both low-dose and high-dose groups experienced notable reductions in AHI.
The study enrolled 121 adult patients with moderate to severe OSA. Over a 28-day period, participants received either a low dose, high dose, or placebo formulation of IHL-42X. In addition to reducing AHI, the drug improved oxygen desaturation levels, sleep quality based on patient-reported outcomes, and daytime fatigue.
The company emphasized that IHL-42X had an “outstanding safety profile,” reporting no serious adverse events throughout the trial. Mild to moderate treatment-emergent side effects were infrequent.
“We are extremely pleased with the RePOSA trial results. The combination of statistically significant improvements across multiple endpoints and an outstanding safety profile positions IHL-42X as one of the most compelling drug candidates in the global race to bring a pharmaceutical treatment for OSA to market,” said Joel Latham, President and CEO of Incannex.
Following the successful trial, Incannex plans to hold an End-of-Phase 2 meeting with the FDA to align on its Phase 3 clinical strategy and regulatory path.
The company pointed out that over 900 million people worldwide suffer from OSA, and no oral pharmaceutical therapies have yet been approved for this condition.
Incannex Healthcare stock price
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