GREENWOOD VILLAGE, Colo. and LOS ANGELES, July 26, 2022 /PRNewswire/ — ANANDA Scientific Inc., a research focused bio-pharmaceutical company today announced the first patient enrolled in the clinical trial evaluating Nantheia™ ATL5, an investigational drug using cannabidiol (CBD) in ANANDA’s proprietary delivery technology as an Adjunctive Treatment for Opioid Use Disorder. (Clinical Trials.gov Identifier: NCT03787628)
This trial is being led by principal investigators Edythe London, Ph.D., Distinguished Professor of Psychiatry and Biobehavioral Sciences as well as Molecular and Medicinal Pharmacology at the Semel Institute, Geffen School of Medicine UCLA, and Richard De La Garza II, Ph.D., Professor of Psychiatry and Biobehavioral Sciences at the Semel Institute, Geffen School of Medicine UCLA. Funding for this trial is from the National Institute on Drug Abuse (NIDA).
“The first patient enrolled in this study is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder,” said Dr. London. “Bridging psychiatry, pharmacology and neuroscience, we are looking to develop evidence-based treatments for addiction.”
“We are excited to be moving this trial forward after completing all the preparatory work.” said Dr. De La Garza. “We hope this clinical trial will answer important questions about the potential of cannabidiol in the treatment of opioid addiction.”
“We are delighted to have the first patient enrolled in this important trial of our investigational drug Nantheia™ ATL5. This clinical study is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet need,” said Sohail R. Zaidi, ANANDA’s Chief Executive Officer (CEO). “We are impressed by the clinical competence and operational diligence of the clinical trial team at UCLA which makes them our partner of choice for future trials as we develop the clinical program”
This will be a randomized, double-blind, placebo controlled, sequential, dose-ranging study of Cannabidiol (CBD) (600, 1200 mg/day) as an adjunctive therapy to buprenorphine and naloxone in patients who have Opioid Use Disorder and are receiving residential behavioral therapy, including cognitive behavioral therapy. The primary endpoint will be safety and tolerability of CBD in these patients, Secondary measures will include cue-induced craving, reductions in spontaneous craving, opioid withdrawal, negative affective states, and relapse, as well as retention in treatment with buprenorphine and naloxone.
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.
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 US, Australia, and the UK, with expansion into additional markets such as the EU, China, Africa, and other countries in Asia.