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NEW YORK/MELBOURNE - Incannex Healthcare Inc. (NASDAQ:IXHL), a $100 million market cap biotechnology company, announced Wednesday that its oral drug candidate for obstructive sleep apnea (OSA), IHL-42X, demonstrated statistically significant improvements in a Phase 2 clinical trial. InvestingPro data shows the company is expected to grow revenues by 16% this fiscal year.
The RePOSA trial showed the drug reduced the Apnea-Hypopnea Index (AHI), the primary measure of OSA severity, by up to 83% from baseline in the high-dose group and up to 79% in the low-dose group compared to placebo.
According to the company’s press release, 41.2% of patients in the high-dose group achieved greater than 30% reduction in AHI, while 14.7% experienced reductions exceeding 50%.
The trial also reported statistically significant improvements in oxygen desaturation index and patient-reported outcomes including sleep-related impairment and fatigue measures.
The double-blind, placebo-controlled study 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.
No serious adverse events were reported during the treatment period, with most treatment-emergent adverse effects described as mild or moderate.
"We are extremely pleased with the RePOSA trial results," said Joel Latham, CEO and President of Incannex, in the statement. "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."
The company is preparing for an End-of-Phase 2 meeting with the FDA to discuss the path forward for the drug candidate, which combines dronabinol and acetazolamide.
OSA affects over 900 million people globally with no approved oral pharmaceutical treatments currently available, according to the company. While currently showing a weak financial health score according to InvestingPro analysis, the company’s liquid assets exceed its short-term obligations, potentially positioning it well for future development phases. Subscribers can access 10+ additional ProTips and detailed financial metrics to better evaluate the company’s potential.
In other recent news, Incannex Healthcare announced a significant expansion of its at-the-market offering program, increasing its capacity by an additional $100 million. This move allows the company to issue more shares under its existing agreement with A.G.P./Alliance Global Partners and Curvature Securities LLC. The company previously sold shares with a gross sales price of approximately $63.47 million. Additionally, Incannex Healthcare has made strategic appointments to its Clinical Advisory Board for its IHL-42X treatment for obstructive sleep apnea. Dr. Charlene E. Gamaldo, a professor at Johns Hopkins School of Medicine, and Dr. Douglas B. Kirsch, Medical Director of Atrium Health Sleep Medicine, have joined the board to lend their expertise. These appointments are part of the company’s efforts to advance the development of its investigational treatment. These developments reflect the company’s ongoing strategic initiatives in expanding its financial and clinical capabilities.
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