FDA Approves IHL-42X for Obstructive Sleep Apnoea Treatment – Promising Results from Phase 2 Study
In a groundbreaking development, the US Food and Drug Administration (FDA) has given its stamp of approval to Incannex Healthcare’s Investigational New Drug (IND) application for IHL-42X, a potential treatment for obstructive sleep apnoea (OSA). This condition, which currently lacks an approved pharmaceutical treatment, affects countless individuals worldwide, making this approval a significant milestone in addressing a pressing medical need.
Incannex Healthcare (ASX:IHL), a clinical-stage pharmaceutical company focused on developing medicinal cannabinoid products and psychedelic assisted psychotherapies, has been at the forefront of research to address unmet needs, including OSA.
Impressive results from recent phase 2 testing of IHL-42X speak to its potential in combating OSA. The drug, made from a synthetic form of tetrahydrocannabinol (THC) and acetazolamide, a carbonic anhydrase inhibitor, demonstrated a profound impact on the condition. On average, it reduced the apnoea-hypopnoea index (AHI) by an impressive 50.7% compared to baseline assessments. Additionally, 25% of participants experienced a remarkable reduction of over 80% in AHI levels.
One of the most significant advantages of IHL-42X is its safety profile. During the clinical trial, no serious treatment emergent adverse events were reported. Furthermore, THC concentrations in the blood were found to be below the limits for impaired driving the morning after nocturnal dose administration, mitigating concerns surrounding potential side effects.
With FDA approval in hand, Incannex Healthcare is now set to conduct an Investigational New Drug (IND) opening pivotal IHL-42X Phase 2/3 clinical trial in the United States as planned. This milestone is critical for progressing investigational drugs through the stages of development, allowing companies to gain regulatory approval, conduct clinical trials, and engage in scientific dialogue with the FDA.
Obstructive sleep apnoea (OSA) is a prevalent sleep-related breathing disorder characterized by the narrowing of the upper airway during sleep. This narrowing leads to compromised breathing, reduced oxygen intake, and disrupted sleep quality. Left untreated, OSA can result in severe long-term health complications, including hypertension, cardiovascular disease, heart attacks, cognitive decline, anxiety, depression, irritability, and daytime fatigue. Additionally, it increases the risk of accidents.
Current treatment approaches for OSA primarily revolve around the use of Continuous Positive Airway Pressure (CPAP) machines. However, patient adherence to CPAP treatment is often compromised due to discomfort-related factors, presenting a challenge in effectively managing the condition.
The global market for sleep apnoea devices is projected to reach a value of $12.88 billion by 2030, with a compound annual growth rate (CAGR) of 6.9%. With its novel pharmaceutical solution, IHL-42X, Incannex Healthcare is well-positioned to tap into this lucrative market.
The upcoming IND opening Phase 2/3 clinical trial will evaluate the efficacy of IHL-42X in OSA patients who are non-compliant, intolerant, or new to positive airway pressure treatment, such as CPAP devices. Participants will receive either IHL-42X, dronabinol, acetazolamide, or a placebo for the duration of the trial. Multiple assessments, including daily surveys on sleep quality, monthly clinic visits to assess functional outcomes, and overnight polysomnography to determine the impact of treatment on the Apnea Hypopnea Index (AHI), will be conducted.
Incannex Healthcare has partnered with Fortrea (NASDAQ: FTRE), a contract research organization (CRO), to oversee the opening of Phase 2/3 clinical trials. Leveraging Fortrea’s extensive expertise in clinical trial solutions, the partnership aims to enhance study recruitment, ensure data quality, and gather operational insights as the trial progresses.
The approval of IHL-42X by the FDA marks a significant breakthrough in the treatment of obstructive sleep apnoea. With promising results from phase 2 studies and FDA support for advanced clinical trials, Incannex Healthcare is poised to make a lasting impact in addressing this unmet medical need. As the company progresses in its mission to develop innovative and effective treatments for OSA, patients and healthcare providers can look forward to a brighter future with improved quality of life and enhanced overall health.
