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MELBOURNE/NEW YORK - Incannex Healthcare Inc. (NASDAQ:IXHL), a $43.33 million market cap biotech company, announced Friday that patients in its Phase 2 trial for obstructive sleep apnea (OSA) treatment IHL-42X reported meaningful improvements in sleep quality and daily functioning. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it remains unprofitable with negative earnings of $1.21 per share over the last twelve months.
According to exit interviews conducted with trial participants, 57.6% reported perceived improvements in their OSA condition, with 89.5% of those describing the changes as meaningful to their lives. Patients noted better sleep quality, feeling more refreshed in the morning, reduced daytime sleepiness, fewer cognitive disturbances, and greater ease in completing daily tasks.
The patient-reported outcomes complement clinical data from the RePOSA Phase 2 trial, which showed statistically significant reductions in the Apnea-Hypopnea Index (AHI) compared to placebo. The company reported maximum AHI reductions of up to 83% in the high-dose group and up to 79% in the low-dose group.
Additional clinical benefits included improvements in oxygen desaturation index and various sleep quality measures. The treatment did not reduce REM sleep, which the company noted distinguishes it from many other sleep medications.
No serious adverse events were reported during the treatment period, with most side effects being mild or moderate.
Joel Latham, President and CEO of Incannex, stated that the results "exceeded expectations" and could potentially "shift the treatment paradigm for OSA." The market appears to be responding positively to these developments, with the stock showing a significant 19.97% return over the past week. InvestingPro analysis indicates the stock is currently trading below its Fair Value, with 14 additional ProTips available for subscribers seeking deeper insights into the company’s potential.
The exit interviews were conducted in alignment with FDA guidance on Patient-Focused Drug Development and included subjects from all three trial arms: placebo, low-dose IHL-42X, and high-dose IHL-42X. For investors interested in comprehensive financial analysis and real-time updates on IXHL’s development progress, InvestingPro offers detailed metrics, including cash flow analysis and growth forecasts.
Incannex’s announcement was based on a company press release statement.
In other recent news, Incannex Healthcare Inc. reported positive results from its Phase 2 clinical trial for IHL-42X, an oral drug candidate for obstructive sleep apnea. The RePOSA trial demonstrated statistically significant improvements, with the high-dose group showing an 83% reduction in the Apnea-Hypopnea Index compared to placebo. Additionally, Incannex announced a significant offering of common shares worth up to $100 million, increasing the amount of shares available under its agreement with A.G.P./Alliance Global Partners and Curvature Securities LLC. This move follows previous sales with an aggregate gross sales price of approximately $63.47 million. Furthermore, Incannex has appointed Dr. Charlene E. Gamaldo, a sleep medicine expert from Johns Hopkins School of Medicine, to its IHL-42X Obstructive Sleep Apnea Clinical Advisory Board. Dr. Gamaldo holds multiple positions at Johns Hopkins, including Vice Chair for Faculty Development in the Neurology Department. These developments mark significant steps for Incannex in advancing its sleep apnea treatment and expanding its financial resources.
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