Nobilis Therapeutics, a biopharmaceutical company focused on the advancement of innovative CNS therapies, today announced that it has filed an Investigational New Drug application (IND) with the U.S. Food & Drug Administration (FDA) to initiate a Phase 2b clinical trial of its lead drug candidate NBTX-001 in patients with panic disorder (PD).
“Adding a PD trial to a recently IND cleared phase 2b/3 PTSD program significantly strengthens Nobilis Therapeutics pipeline,” remarked Vlad Bogin, founder and CEO of Nobilis Therapeutics. “Our published pilot data in 80 patients with PD showed remarkable signals of efficacy and our safe and instantly bioavailable therapeutic is well positioned to bring the needed paradigm shift to how we manage a wide range of psychiatric conditions. Given that both PD and PTSD have emerged as cardinal disorders linked to COVID-19 mental health crisis, rapidly advancing NBTX-001 development has never been more critical,” concluded Dr. Bogin.
NBTX-001 is a uniquely engineered drug-device combination specifically designed to provide a differentiated pharmaceutical therapy for the treatment of PTSD. Its proprietary portable inhalation device delivers a xenon gas mixture that has an exceptional safety profile proven by decades of clinical use in general anesthesia. Xenon is a competitive NMDA receptor antagonist devoid of dissociative and habit-forming properties which gives it distinct advantages over other agents in its class. It can be administered briefly in a safe and effective manner via a patent-pending portable inhalation device. In December of 2019 NBTX-001 was cleared for a phase 2b clinical trial in about 200 patients with PTSD. The trial will commence in around 20 U.S. sites with Harvard’s McLean Hospital being the leading institution.
About the PD clinical trial
The filed IND covers the investigational use of NBTX-001 in a phase 2b placebo-controlled, parallel group clinical trial of around 200 patients with PD. The primary endpoint of this study is the change in Panic Disorder Severity Scale (PDSS) score. The five-week treatment duration (six treatments) will provide enough time to achieve maximal anti-PD effects. The seven-week follow-up will provide enough time to assess the long-term sustainability of the effect. The study is well-powered to determine the difference in the PDSS score between the active and the placebo groups and, if successful, will be followed by a pivotal trial.
About Nobilis Therapeutics
Nobilis Therapeutics is a biotechnology company that is focused on development and commercialization of proprietary inhalation-based treatments using controlled device administration of inert gases that have an exceptional safety profile proven by decades of clinical use. The company has filed multiple patents on the use of inert gases for treatment of a variety of psychiatric and neurodegenerative diseases and leverages the experience of its international team that has successfully used this technology in the treatment of over 3,000 patients for conditions ranging from panic attacks to substance abuse.
For more information, please visit Nobilis Therapeutics online at https://www.nobilistx.com.
Nobilis Therapeutics Inc.
Vlad Bogin, MD, FACP
Tel: (971) 229-1679