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.