Nobilis Therapeutics, a biopharmaceutical company today announced that the U.S. Food & Drug Administration (FDA) has allowed it to initiate a Phase 2b clinical trial of its lead drug candidate NBTX-001 in patients with Panic Disorder.
PORTLAND, ORE. (PRWEB) JULY 22, 2020
Nobilis Therapeutics, a clinical stage biotechnology company focused on advancement of innovative CNS therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for NBTX-001 Inhaler, allowing the Company to initiate its Phase 2b trial for the treatment of patients with Panic Disorder (PD).
“We are very excited to receive FDA IND clearance for NBTX-001 drug-device combination,” said Dr. Vlad Bogin, Company’s Founder and CEO. “Being allowed to proceed with the study during the ongoing COVID-19 pandemic could not be timelier. Addition of PD indication to the already cleared phase 2b trial in patients with PTSD is giving Nobilis Therapeutic a unique opportunity to address the two most severe manifestations of the emerging worldwide mental health crisis,” 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.
Company’s first clinical trial in 81 patients with Panic Disorder showed significant signals of efficacy. In 2016 the Company entered into an exclusive licensing agreement with Harvard University on the use of NBTX-001 in PTSD and had a patent issued in 2017. Of its 14 independently filed patents 5 have been issued. In January of 2019 the Company had entered into collaboration with Linde AG to support its medical device and clinical development program.
For more information, please visit Nobilis Therapeutics online at https://www.nobilistx.com.
Nobilis Therapeutics Inc.
Vlad Bogin, MD, FACP
Tel: (971) 229-1679