University of Nebraska Medical Center and ANANDA Scientific announce FDA approval of the IND for a Clinical Trial exploring Treatment for Post-Traumatic Stress Disorder (PTSD)

(Photo: Business Wire)

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The University of Nebraska Medical Center (UNMC) and ANANDA Scientific Inc announce a collaboration in a new clinical trial investigating treatment for adults with Post-Traumatic Stress Disorder (PTSD).

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The trial is being led by principal investigator Mathew Rizzo, M.D., the Reynolds Professor and chair of the UNMC Department of Neurological Sciences and Chief Physician for neurological services at Nebraska Medicine.

The study will evaluate the effectiveness of Nantheia™ ATL5, an investigational drug using cannabidiol in ANANDA’s proprietary delivery technology. An investigational new drug (IND) application for the trial has been approved by the U.S. Food and Drug Administration (FDA).

(Clinical Trials.gov Identifier NCT05269459)

“This is our second clinical trial targeting PTSD.We are excited that UNMC’s research team has partnered with us to evaluate our promising drugfor this very debilitating condition,”said Sohail R. Zaidi, ANANDA’s Chief Executive Officer. “It is an important step in our efforts to provide patients with PTSD with potentially improved therapeutic options.”

“Advancing evidence-based research into new therapeutics to provide a large PTSD patient population with new innovative treatment options is a key objective for our research team,” Dr. Rizzo said. “We are delighted to be collaborating with ANANDA Scientific on this trial.”

Dr. Rizzo also is the director of the National Institutes of Health’s Great Plains IDeA Clinical and Translational Research Network. He chairs the executive committee of the American Brain Coalition which advocates to advance research for neurological cures.

Dr. Rizzo’s research team will include Jennifer Merickel, Ph.D., Cognitive Neuroscientist and Assistant Professor in the UNMC Department of Neurological Sciences and Brigette Vaughan, an Advanced Practice Registered Nurse, Clinician and Researcher in the UNMC Department of Psychiatry.

This phase II double-blind, placebo controlled, randomized clinical study is planning to enroll 240 participants to provide rigorous clinical and real-world evaluation of the efficacy and safety of Nantheia™ ATL5.