ANANDA Scientific announces a clinical trial evaluating Nantheia™ ATL5, in the treatment of concurrent opioid use disorder and chronic pain.

GREENWOOD VILLAGE, Colorado, and NEW HAVEN, Connecticut–(BUSINESS WIRE)–ANANDA Scientific Inc., a research-based biopharmaceutical company, announced today the start of a clinical trial evaluating the Nantheia™ ATL5, an experimental drug that uses cannabidiol (CBD) and leverages the proprietary delivery technology of’ANANDA, co-administered with Δ-9-tetrahydrocannabinol (THC), for its potential efficacy in treating opioid use disorder (OUD) and chronic pain. (ClinicalTrials.gov Identifier: NCT06544291)

The trial will be conducted at Yale School of Medicine. The study will be led by principal investigator Joao P. De Aquino, M.D., director of the Pain and Addiction Interaction (PAIN) Neuroscience Laboratory and associate chief of hospital psychiatry at Yale School of Medicine. Funding for this trial comes from a grant from the National Institute on Drug Abuse (NIDA).

The main objective of this study is to explore the therapeutic potential of the Nantheia™ ATL5, administered in combination with THC to relieve pain and stimulus-induced cravings in people with opioid-related disorders and chronic pain. The secondary objective is to determine whether the addition of a dose THC independently alters the effect of the Nantheia™ ATL5 (CBD) alone.

This will be a randomized, double-blind, placebo-controlled study involving participants who are receiving stable doses of methadone and who are randomly assigned to receive single doses of Nantheia™ ATL5 (CBD 200 mg, 400 mg, or placebo), with THC (5 mg, 10 mg, or placebo).

«We are delighted to be collaborating with ANANDA »to launch this trial,« said Dr. De Aquino. »Understanding how CBD, when administered alongside low doses of THC, can benefit patients with OUD and chronic pain could lead to significant advances in the treatment of these debilitating conditions.”

«We are delighted to be working with Dr. De Aquino and the Yale School of Medicine on this important trial for our experimental drug" Nantheia™ ATL5 », said Sohail R. Zaidi, President and Chief Executive Officer of ANANDA. «This clinical trial represents another step forward in our clinical development efforts focused on opioid addiction, where a non-addictive therapy addresses a critical unmet medical need.»

ABOUT NANTHEIA™ ATL5

Nantheia™ ATL5 is an experimental drug that combines cannabidiol with delivery technology Liquid Structure™ exclusive from’ANANDA. Initial preclinical and clinical studies show that the delivery technology Liquid StructureANANDA’s ™ (licensed from Lyotropic Delivery Systems (LDS) Ltd. in Jerusalem, Israel) improves the efficacy, consistent absorption, and stability of cannabidiol. Nantheia™ ATL5 is an oral product containing 100 mg of cannabidiol per softgel.

About ANANDA Scientific

ANANDA Scientific is a leading, research-driven biopharmaceutical company dedicated to developing groundbreaking medicines to transform neuropsychiatric health. The company is currently conducting high-level clinical trials evaluating therapeutic indications such as PTSD (post-traumatic stress disorder), pain, anxiety, opioid use disorder, and smoking cessation. The company’s patented delivery technology makes cannabinoids and plant-derived compounds highly bioavailable, water-soluble, and stable over the long term. ANANDA Scientific is committed to producing effective, high-quality pharmaceutical products that improve patients' lives.

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Contact

For more information, please contact:

ANANDA Scientific Inc.

Chris Moore

[email protected]