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:8/12/2020)... ... August 12, 2020 , ... Inc. magazine today revealed that ... FDA compliance consulting has been named on its annual Inc. 5000 list, the ... unique look at the most successful companies within the American economy’s most dynamic ...
(Date:8/3/2020)... ... August 03, 2020 , ... Introducing Ardent Animal Health – MediVet Biologics rebrands ... , Known as MediVet Biologics since its formation in 2016, the company is ... Animal Health will build on its base of innovative therapies for osteoarthritis and cancer. ...
(Date:7/31/2020)... ... July 29, 2020 , ... Diversified Technologies, Inc. ... can be configured to drive Klystrons, TWTs, IOTs, and magnetrons. , DTI ... two switches in a push-pull configuration; yielding fast fall time for a capacitive ...
(Date:7/31/2020)... ... , ... eSource has long been touted as the solution to high data ... the reasons it did not take off as quickly as people initially expected, and ... moving towards capturing data electronically for clinical trials and then repurposing it for downstream ...
Breaking Biology Technology:
(Date:7/10/2020)... ... July 08, 2020 , ... ... Gene Therapy Regulation, An FDAnews Webinar, Wednesday, July 22, 2020 • 1:30 p.m.-3:00 ... but what is the most effective way to complete one? Will the study ...
(Date:7/2/2020)... ... July 02, 2020 , ... Dutch ... the use of its revolutionary NEXTGENPCR endpoint thermocycler to test for SARS-CoV-2 ... The article, titled "Ultra-fast one-step RT-PCR protocol for the detection of SARS-CoV-2," ...
(Date:6/28/2020)... ... ... In an upcoming episode scheduled for the fall of 2020, Advancements with Ted ... local listings for more info. , Today, the majority of testing is performed at ... the country. Results are then available several days later. Now, in an effort to ...
Breaking Biology News(10 mins):