The granted patent protects the proprietary oral combination therapy through at least 2040, as the company prepares to launch its Phase 2 dose optimization study.
Key takeaways:
- The USPTO granted a patent for IHL-42X, an oral combination therapy for OSA, with an expected baseline expiration of July 2040.
- Incannex is nearing patient recruitment for its DReAMzz Phase 2 crossover dose optimization study, having secured initial IRB approvals.
- The company plans to explore patent term extensions following potential FDA approval to further enhance long-term market exclusivity.
The US Patent and Trademark Office (USPTO) has granted a patent to clinical-stage biopharmaceutical company Incannex Healthcare Inc for its proprietary obstructive sleep apnea (OSA) treatment candidate, IHL-42X.
The patent, titled “Compositions and Methods of Treatment for Obstructive Sleep Apnoea (OSA),” includes claims directed to the IHL-42X composition and its associated therapeutic methods. It has an expected baseline expiry date of July 9, 2040. Incannex is exploring eligibility for a patent term extension following potential US Food and Drug Administration (FDA) approval to further enhance the asset’s long-term exclusivity.
IHL-42X is being developed as an oral combination therapy for OSA.
“The grant of this US patent represents another major milestone in the evolution of the IHL-42X program and further validates what we believe is one of the most compelling development opportunities in sleep medicine. OSA…remains a significantly underserved market where current treatment options continue to suffer from poor long-term patient adherence,” says Joel Latham, president and CEO of Incannex, in a release. “We believe this creates an extraordinary commercial opportunity for a safe, effective and convenient oral pharmaceutical therapy.”
The patent grant follows the company’s successful RePOSA phase 2 study and the FDA granting Fast Track designation for IHL-42X. Incannex is now nearing the commencement of patient recruitment for its DReAMzz phase 2 study.
The DReAMzz trial is designed as a crossover dose optimization study intended to refine the dosing profile of IHL-42X and strengthen the design of a planned phase 3 development program. It will evaluate the relationship between dose optimization, objective sleep metrics, and patient-reported outcomes.
The study has received central institutional review board (IRB) approval along with the first tranche of site-specific IRB approvals. Study-specific Schedule I researcher registrations with the Drug Enforcement Administration (DEA) are underway. The first site will commence screening in the near future, and study drug supply has been shipped for secondary packaging and clinical trial labeling in preparation for patient dosing.
Latham says. “Combined with the clinical progress we have achieved, we believe IHL-42X is becoming an increasingly valuable pharmaceutical asset with the potential to address one of the largest unmet needs in sleep medicine.”
