ANANDA Scientific מודיעה על אישור ה-FDA של ה-IND לניסוי קליני הבוחן טיפול בהפרעת חרדה חברתית (SAD)
ANANDA Scientific Inc,
חברת ביו-פרמצבטיקה ממוקדת מחקר הודיעה היום על אישור מנהל המזון והתרופות האמריקני (FDA) לבקשת IND לניסוי קליני המעריך את Nantheia™ A1002N5S, תרופה ניסיונית המשתמשת בקנאבידיול (CBD) בטכנולוגיית Liquid
Structure™ הנוזלי הקניינית של ANANDA כטיפול פוטנציאלי להפרעת חרדה חברתית. המרכז הלאומי
לבריאות משלימה ואינטגרטיבית (חטיבת HCCIH-a
של ה-NIH) מספק מימון לניסוי זה שייערך בבית הספר לרפואה ע"ש גרוסמן
באוניברסיטת ניו יורק.
ANANDA Scientific Announces FDA Approval of the IND for a Clinical Trial exploring
treatment of Social Anxiety Disorder (SAD)
NEW YORK & GREENWOOD VILLAGE, Colo., 30 November
2022, (BUSINESS
WIRE):
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)
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.
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