Nobilis files IND for trial to study drug-device PTSD therapy

Nobilis Therapeutics said yesterday that it filed an investigational new drug application with the FDA to kick off a Phase IIb trial of its NBTX-001 drug-device PTSD therapy.

The Portland, Ore.-based company is developing a portable inhalation device designed to deliver a xenon gas mixture.

Nobilis plans to conduct a 200-patient clinical trial with both combat-related and non-military forms of PTSD. The study will include five weeks of treatment and a seven-week follow-up period.

If the study is successful, Nobilis said it will conduct a pivotal trial.

“This IND filing is an important step forward for the company as it looks to position NBTX-001 as a dramatic departure from conventional treatments for psychiatric diseases. PTSD is a devastating disease associated with tremendous emotional and financial costs to the health care system that is devoid of effective treatment options,” founder & CEO Dr. Vlad Bogin said in prepared remarks.

“As we enter the clinical stage of development, our focus is to continue to advance NBTX-001 rapidly through its planned clinical program together with the clinical team at McLean Hospital, psychiatric affiliate of Harvard Medical School,” Bogin added.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.