Navigation Links
Nobilis Therapeutics Announces IND Filing for a Phase 2b Clinical Trial of NBTX-001 Drug/Device Combination for Treatment of Panic Disorder
Date:6/23/2020

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.

About NBTX-001

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 http://www.nobilistx.com.

Contacts:

Nobilis Therapeutics Inc.
Vlad Bogin, MD, FACP
CEO
Tel: (971) 229-1679
Email: vbogin@nobilistx.com
Website: http://www.nobilistx.com
Twitter: @nobilistx

Read the full story at https://www.prweb.com/releases/nobilis_therapeutics_announces_ind_filing_for_a_phase_2b_clinical_trial_of_nbtx_001_drug_device_combination_for_treatment_of_panic_disorder/prweb17207407.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related biology technology :

1. Nobilis Therapeutics Announces Completion of Landmark NBTX-001 Clinical Trial in 81 Patients with Panic Disorder
2. Peptide Therapeutics Market is Expected to Reach USD 25.4 Billion Globally in 2018: Transparency Market Research
3. Novira Therapeutics Completes $25 Million Series A Financing
4. Biovista und DART Therapeutics nehmen Zusammenarbeit auf, um auf Duchenne-Muskeldystrophie abzielende Medikamente neu zu positionieren
5. Aratana Therapeutics Adds To Drug Development Team
6. Galectin Therapeutics Reports Full Year and Fourth Quarter 2012 Financial Results
7. Galectin Therapeutics: Turning Atlanta into Americas Next Silicon Valley
8. Resverlogix desincorpora RVX Therapeutics Inc. para sus accionistas
9. Inflamax Research Chosen to Conduct a Multicenter Environmental Exposure Chamber Phase 3 Study of Ultrashort Grass Allergy Vaccine by Allergy Therapeutics (UK) Ltd.
10. Nanotherapeutics Awarded Defense Department Contract for Advanced Development and Manufacturing of Medical Countermeasures
11. United Therapeutics Corporation To Announce First Quarter 2013 Financial Results Before Market Open On Thursday, April 25, 2013
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2020)... (PRWEB) , ... June 23, 2020 , ... ... facilitate access to unique lab-made bioresearch materials, today announced the availability of the ... Whitt laboratory at University of Tennessee, enables studies of SARS-CoV-2 viral entry and ...
(Date:6/19/2020)... ... ... The Vitaspace project was founded by the famous Russian entrepreneur ... and find a way (medicine or technology) that will help to preserve youth, restore ... from all over the world, doctors, and all people who care. , The other ...
(Date:6/3/2020)... (PRWEB) , ... June 03, 2020 , ... ... to highlight various applications of biofeedback. In the next installment, Dr. Inna Khazan ... practice whereby individuals learn to bring their attention to the feelings, thoughts, and ...
(Date:5/28/2020)... (PRWEB) , ... May 28, 2020 , ... The ... and security leaders as the 2020 winners of the Women in Biometrics Awards ... sponsors IDEMIA , Biometric Update and the SIA Women in ...
Breaking Biology Technology:
(Date:5/25/2020)... United Kingdom (PRWEB) , ... May 22, 2020 , ... ... (assay) for the detection of SARS-CoV-2, the virus that causes COVID-19. , ... to on-demand analysis of smaller sample numbers, to very large numbers of samples. ...
(Date:5/21/2020)... ... May 19, 2020 , ... ... operations management solutions, today introduced BioMed to their award-winning computerized maintenance management ... connecting the people and systems around biomedical engineering to better allocate staff ...
(Date:5/21/2020)... ... May 20, 2020 , ... Law Enforcement has always been a highly stressful ... The positions of these men and women put them constantly in harm’s way both ... precisely. Officers have always had to face very high daily stress. Now, COVID-19 introduces ...
Breaking Biology News(10 mins):