University of Nebraska Medical Center and ANANDA Scientific announce that their IND has been approved by the FDA for a clinical trial examining the treatment of post-traumatic stress disorder (PTSD)

OMAHA, Nebraska, and GREENWOOD VILLAGE, Colorado–(BUSINESS WIRE)–The University of Nebraska Medical Center (UNMC) and ANANDA Scientific Inc. have announced a collaboration as part of a new clinical trial examining the treatment of adult patients with post-traumatic stress disorder (PTSD).

The trial is currently being led by the principal investigator, Dr. Mathew Rizzo, Reynolds Professor and Chair of the Department of Neurological Sciences at UNMC and Chief of Neurology at Nebraska Medicine.

The study will evaluate the efficacy of Nantheia™ ATL5, an investigational drug that uses cannabidiol in a proprietary delivery technology from’ANANDA. An Investigational New Drug (IND) application was approved by the U.S. Food and Drug Administration (FDA) for this trial.

(ClinicalTrials.gov ID: NCT05269459)

«This is our second clinical trial targeting PTSD. We are delighted that the UNMC research team is partnering with us to evaluate our promising drug »for this particularly debilitating condition,", said Sohail R. Zaidi, President and Chief Executive Officer of’ANANDA. «This is an important step in our efforts to offer patients with PTSD potentially improved treatment options.»

«Promoting evidence-based research to develop new therapeutic products for a broad population of patients with PTSD, through innovative new treatment options, is a key objective for our research team,» said Dr. Rizzo. «We are delighted to be collaborating with ANANDA Scientific on this trial.»

Dr. Rizzo is also 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 promotes research in the field of neurological treatments.

Dr. Rizzo’s research team will include Jennifer Merickel, Ph.D., a specialist in cognitive neuroscience and assistant professor in the Department of Neurological Sciences at UNMC, and Brigette Vaughan, an advanced practice nurse, clinician, and researcher in the Department of Psychiatry at UNMC.

This randomized, double-blind, placebo-controlled Phase II clinical trial is expected to include 240 participants in order to provide a rigorous real-world and clinical assessment of the efficacy and safety of the Nantheia™ ATL5.

ABOUT THE NANTHEIA™ ATL5

The Nantheia™ ATL5 is an investigational drug that uses cannabidiol in ANANDA’s proprietary delivery technology, Liquid Structure. Preclinical and initial clinical studies show that ANANDA’s Liquid Structure™ delivery technology (licensed from Lyotropic Delivery Systems (LDS) Ltd. in Jerusalem, Israel) improves the efficacy and stability of cannabidiol. The Nantheia™ ATL5 is an oral product containing 100 mg of cannabidiol per softgel.

About the University of Nebraska Medical Center

As Nebraska’s only public academic center for health sciences, UNMC is committed to educating 21st-century health care professionals to find cures and treatments for devastating diseases, provide the best patient care, and serve the state of Nebraska and its communities through award-winning public outreach. UNMC has six schools and two institutes that serve more than 4,200 students across some 20 programs. UNMC researchers conduct cutting-edge research in the fields of neuroscience, oncology, infectious diseases, and other key areas.

ABOUT ANANDA SCIENTIFIC

ANANDA is a leading research-focused biopharmaceutical company and a pioneer in high-caliber clinical studies designed to evaluate therapeutic indications such as PTSD, radicular pain, anxiety, and opioid use disorder (Mount Sinai and UCLA). Using patented delivery technology designed to make cannabinoids and other plant-derived compounds highly bioavailable, water-soluble, and stable throughout their shelf life, the company focuses on producing effective, high-quality pharmaceutical products. The company is currently expanding its research infrastructure through multiple grant-funded research agreements with universities to diversify its clinical portfolio. Building on its robust research-based data, the company has a growing portfolio of over-the-counter nutraceutical products. ANANDA has successfully launched these products in the United States, Australia, and the United Kingdom, and is expanding its presence into other markets such as the EU, China, Africa, and other Asian countries.

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Contact

ANANDA Scientific, Media Relations | Christopher Moore | 813 326 4265 | [email protected]