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 drug for 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.
ABOUT NANTHEIA™ ATL5
Nantheia™ ATL5 is an investigational drug that uses cannabidiol in ANANDA’s propriety Liquid Structure delivery technology. Pre-clinical and initial clinical studies show that ANANDA’s Liquid Structure™ delivery technology (licensed from Lyotropic Delivery Systems (LDS) Ltd in Jerusalem, Israel) enhances the effectiveness and stability of cannabidiol. Nantheia™ ATL5 is an oral product with 100mg cannabidiol per softgel capsule.
ABOUT University of Nebraska Medical Center
As Nebraska’s only public academic health sciences center, UNMC is committed to the education of a 21st century health care work force, to finding cures and treatments for devastating diseases, to providing the best care for patients, and to serving the state and its communities through award-winning outreach. UNMC has six colleges and two institutes, serving more than 4,200 students in two dozen programs. Researchers at UNMC perform cutting-edge research in neurological sciences, oncology, infectious disease, and other key areas.
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 to make cannabinoids and other plant derived compounds highly 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. Consistent with its strong research-based data, the company has a growing pipeline of nutraceutical over-the-counter products. ANANDA has successfully launched these products in the U.S., Australia, and the U.K., with expansion into additional markets such as the EU, China, Africa, and other countries in Asia.
