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Nobilis Therapeutics Announces FDA Clearance of IND to Commence Phase 2b Trial of NBTX-001 Inhaler for Treatment of Posttraumatic Stress Disorder

Nobilis Therapeutics, a clinical stage biotechnology company focused on development of treatments for psychiatric and neurodegenerative disorders, 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 Posttraumatic Stress Disorder (PTSD).

“FDA clearance of the IND for NBTX-001 drug-device combination signifies a critical milestone for Nobilis Therapeutics, as it validates its novel approach to treatment of PTSD” said Dr. Vlad Bogin, Company’s Founder and Chief Executive Officer. “Patients with this devastating illness suffer from severely depressed quality of life, deterioration of marital and family relationships, substance abuse and suicidality. Our clinical program is aimed to address not just the symptoms, but the pathophysiology of PTSD.”

Dr. Kerry Ressler, MD, PhD, Professor of Psychiatry at Harvard Medical School, CSO, James and Patricia Poitras Chair in Psychiatry at McLean Hospital, and a Principle investigator of the trial stated: “I am very excited to be helping to lead the NBTX-001 Inhaler trial. I believe that the drug’s competitive inhibition of NMDA receptors, that appears to block trauma memory reconsolidation, may represent an important advance in the treatment of PTSD, a disease with tremendous unmet need for effective medicines.”

NBTX-001 will be a prospective, multicenter, randomized, double-blinded, placebo-controlled phase 2b study that will enroll 190 patients in approximately 25 sites in the United States. The primary endpoint of the study is the mean change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score.

About Posttraumatic Stress Disorder
Posttraumatic Stress Disorder is a devastating psychiatric condition associated with tremendous emotional and financial costs to the health care system. It is estimated that approximately 6.1% of Americans will suffer from PTSD at one point in their lives, with significantly higher proportions in war veterans suffering from PTSD (approximately 12% to 30%).

Currently the main treatment interventions for PTSD include psychotropic medications and/or psychotherapy. The selective serotonin reuptake inhibitor (SSRI) antidepressants, sertraline and paroxetine, are the only US Food and Drug Administration (FDA) approved medications for the condition that show limited clinical improvement in PTSD sufferers. National Center for PTSD (NCPTSD) treatment guideline recommends Exposure Therapy as one of the most robust treatments. However, although it has shown to be efficacious for treatment of PTSD, a recent randomized clinical study in 370 military personnel with PTSD showed relatively modest reductions in PTSD symptom severity.

PTSD remains a disease with tremendous unmet need currently with only limited effective treatments.

About Nobilis Therapeutics, Inc.
Nobilis Therapeutics is a biotechnology company that is focused on development and commercialization of proprietary inhalation-based treatments using portable controlled device administration of inert gases. The Company has filed multiple patents on the use of inert gases for treatment of a variety of psychiatric, neurodegenerative and other diseases and leverages the experience of its international team that has studied this technology in the treatment of over 2500 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 the next year. Of its 14 independently filed patents 3 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.

Vlad Bogin, MD, FACP
US Bancorp Tower, 111 S.W. Fifth Avenue, Suite 3150, Portland, OR, 97204, USA
Tel: (971) 229-1679
Twitter: @nobilistx

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