ANANDA Scientific Announces First Patient Enrolled in FDA-approved Clinical Trial Evaluating a Potential New Treatment for Social Anxiety Disorder (SAD)

ANANDA Scientific Inc., a research focused bio-pharmaceutical company today announced that the first subject has been enrolled in the clinical trial with an FDA-approved IND evaluating Nantheiatm A1002N5S, an investigational drug using cannabidiol (CBD) in ANANDA's proprietary Liquid Structuretm delivery technology as a potential treatment for Social Anxiety Disorder (SAD). The National Center for Complimentary and Integrative Health (NCCIH-a division of the NIH) is providing funding for this trial which is being conducted at the NYU Grossman School of Medicine. (Clinical Trials.gov Identifier: NCT05571592)

The trial is being led by Principal Investigators Naomi Simon, MD, MSc., Professor of Psychiatry and Director of Anxiety, Stress and Prolonged Grief Program at the NYU Grossman School of Medicine and Esther Blessing, MD, PhD, Assistant Professor of Psychiatry at NYU Grossman School of Medicine. This double-blind placebo-controlled trial is studying Nantheia^TM A1002N5S versus placebo over a 21-day treatment period with the primary outcome measures being the change in Trier Social Stress Test (TSST) induced Anxiety and impact on a neuroimaging biomarker.

"We are very pleased to have this important study underway," said Dr. Simon. "Our collaboration with ANANDA is helping us complete our NIH funded research study of CBD, which is aimed at developing scientific evidence about its mechanism and clinical effects to support the potential development of CBD as a new evidence-based treatment for Social Anxiety Disorder, a distressing and under-addressed condition."

Dr. Blessing noted "preclinical results for CBD as a treatment for anxiety disorders show promising results and we look forward to building on these pre-clinical results in this study."

"Enrolling the first subject in this important trial is another key milestone for ANANDA's clinical development program," said Sohail R. Zaidi, ANANDA's CEO. "We are very pleased to be collaborating with the NYU research team in evaluating our investigational drug Nantheia A1002N5S in an indication with a significant unmet medical need."

ABOUT NANTHEIAtm A1002N5S

Nantheiatm A1002N5S is an investigational drug that uses cannabidiol in ANANDA's proprietary Liquid Structure delivery technology. Pre-clinical and initial clinical studies show that ANANDA's Liquid Structuretm delivery technology (licensed from Lyotropic Delivery Systems (LDS) Ltd in Jerusalem, Israel) enhances the effectiveness and stability of cannabidiol. Nantheiatm A1002N5S is an oral product with 50mg cannabidiol per softgel capsule.

ABOUT ANANDA SCIENTIFIC

ANANDA is a leading research-focused biopharmaceutical company pioneering high-caliber clinical studies evaluating therapeutic indications such as PTSD, Radiculopathic Pain, Anxiety and Opioid Use Disorder (Mt. Sinai and UCLA). The company employs patented delivery technology, (licensed from Lyotropic Delivery Systems (LDS) Ltd, in Jerusalem, Israel) to make cannabinoids and plant derived compounds bioavailable, water soluble, and shelf-life stable and focuses on producing effective, premium quality pharmaceutical products. The company is expanding its research base through multiple sponsored research agreements with universities to diversify its clinical portfolio.