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Investing.com -- Incannex Healthcare Inc. (NASDAQ:IXHL) stock rose 10% following the announcement of positive topline results from its Phase 2 clinical trial for IHL-42X, a novel oral drug candidate for obstructive sleep apnea (OSA).
The company reported that its RePOSA trial demonstrated statistically significant improvements across multiple key endpoints. Most notably, IHL-42X reduced the Apnoea-Hypopnoea Index (AHI) by up to 83% from baseline compared to placebo, with both low and high-dose groups showing significant improvements.
The trial enrolled 121 adult participants with moderate to severe OSA who received either a high dose, low dose, or placebo version of IHL-42X for 28 days. The drug also showed improvements in oxygen desaturation, patient-reported outcomes measuring sleep quality, and reduced daytime fatigue.
IHL-42X demonstrated what the company described as an "outstanding safety profile" with no serious adverse events reported during the treatment period. Treatment-emergent adverse effects were infrequent and primarily mild to moderate in severity.
"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, CEO and President of Incannex.
The company is now preparing for an End-of-Phase 2 meeting with the FDA to discuss the path forward for Phase 3 trials and regulatory strategy. Incannex noted that OSA affects over 900 million people globally with no approved oral pharmaceutical treatments currently available.
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