ANANDA Scientific Inc., a research focused bio-pharmaceutical company today announced approval by the US Food and Drug Administration (FDA) of the IND application for a clinical trial evaluating Nantheia™ A1002N5S, an investigational drug using cannabidiol (CBD) in ANANDA’s proprietary Liquid Structure™ delivery technology as a potential treatment for Social Anxiety Disorder. The National Center for Complimentary and Integrative Health (HCCIH-a division of the NIH) is providing funding for this trial which will be conducted at the NYU Grossman School of Medicine. (Clinical Trials.gov Identifier: NCT05571592)
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The Principal Investigators for the trial are 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 will study Nantheia™ 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 delighted to be moving forward with this important study to develop new evidence-based treatments for Social Anxiety Disorder, a distressing and under-addressed condition,” said Dr Simon.
Dr. Blessing noted, “It is exciting to be moving forward with clinical trials that build upon promising preclinical results for CBD as a treatment for anxiety disorders.”
“We are very pleased to again be working with Dr Simon and Dr Blessing on this important trial that could impact the lives of a large number of people,” said Sohail R. Zaidi, ANANDA’s CEO. “We look forward to further advancing applications for our investigational drug Nantheia A1002N5S in an indication with a significant unmet medical need.”
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 pharmaceutical products.