Promising Results for IHL-42X in the Treatment of Obstructive Sleep Apnea
Introduction
The ongoing RePOSA trial is evaluating the safety and efficacy of IHL-42X as a medicinal cannabinoid pharmacotherapy for the treatment of obstructive sleep apnea (OSA). Mark Bleackley, PhD, chief scientific officer at Incannex, has discussed the progress of the clinical trials and the potential implications for affected patients in an interview with The American Journal of Managed Care®.
Proof-of-Concept Study
In a clinical trial conducted in Australia, IHL-42X demonstrated significant promise as a treatment for OSA. Patients receiving IHL-42X experienced a statistically significant reduction in their apnea hypopnea index (AHI), which measures the number of times per hour their breathing is either stopped or reduced, compared to a placebo. The patients also reported better perceived sleep quality while on the IHL-42X treatment period compared to the placebo.
Implications for Affected Patients
The results of the study suggest that IHL-42X could be an effective treatment for OSA, a condition for which there are currently no registered pharmacotherapies available. Dronabinol, a synthetic form of THC, and acetazolamide, the partner active pharmaceutical ingredient in IHL-42X, are also being compared to IHL-42X in the RePOSA study to determine the contribution of each drug to the efficacy and safety of IHL-42X.
Expansion to Phase 2/3
The RePOSA study is currently in phase 2/3, with phase 2 focusing on identifying the optimal dose of IHL-42X. The study will compare two doses of IHL-42X to a placebo over a 28-day treatment period in 120 patients. The optimal dose will then be selected based on the efficacy and safety recorded during the phase 2 study and will be taken forward to phase 3.
Long-Tail Keyword: OSA Treatment
The phase 3 study, involving 440 patients, will extend the treatment period to one year and compare IHL-42X to the component drugs (dronabinol and acetazolamide) and placebo. The results from this study will be a key component in understanding the drug’s efficacy and safety and will be used for regulatory submissions, including to the FDA.
Conclusion
The ongoing RePOSA trial is showing great promise for IHL-42X as a treatment for obstructive sleep apnea. The study’s findings thus far indicate a statistically significant reduction in the AHI, along with improved perceived sleep quality in patients receiving IHL-42X. The results from the ongoing study could lead to the approval of IHL-42X as a safe and effective treatment for OSA.
Interim Results Show Promise for Gene Therapy in Treating Autosomal Recessive Deafness 9
Introduction
Autosomal recessive deafness 9 (DFNB9) is a hereditary condition caused by a mutation in the gene coding for otoferlin. The interim results of a single-arm trial show promising results for binaural administration of gene therapy.
DFNB9 Single-Arm Trial
The interim results of a trial in children with DFNB9 show that binaural administration of gene therapy can lead to better hearing without serious adverse effects. Binaural administration of the gene therapy led to a significant improvement in hearing levels from baseline, with some patients experiencing a near-normalization of hearing.
Implications for DFNB9 Patients
The interim results of the trial suggest that binaural administration of gene therapy could be a viable treatment option for individuals with DFNB9. Notably, the treatment led to significant improvements in hearing levels without any serious adverse effects.
Importance of Patient Care
Ravin Ratan, MD, MEd, of MD Anderson, emphasizes the importance of caring for all patients and owning the process of helping patients feel confident that they received the attention they deserve.
Long-Tail Keyword: Patient Care
Dr. Ratan emphasizes the importance of focusing on the individual patient and providing compassionate care that addresses their unique needs. This approach can lead to better patient outcomes and improve patient satisfaction with their care experience.
Conclusion
The interim results of the DFNB9 single-arm trial show promise for binaural administration of gene therapy as a treatment option for individuals with DFNB9. The treatment led to significant improvements in hearing levels without any serious adverse effects. Additionally, Dr. Ratan emphasizes the importance of compassionate patient care in helping patients feel confident that they received the attention they deserve.
Originally Post From https://www.ajmc.com/view/dr-mark-bleackley-new-medication-set-to-benefit-patients-with-obstructive-sleep-apnea
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