Adolore BioTherapeutics Announces Issuance of First U.S. Patent Covering CA8* Gene Therapies to Treat Chronic Pain

Patent and CA8* gene therapy technology licensed by Adolore Biotherapeutics from the University of Miami

Adolore BioTherapeutics , a biotechnology company focused on developing breakthrough opioid-free gene therapy treatments for chronic pain, announced that the U.S. Patent and Trademark Office (USPTO) has issued patent No. 11,911,450 covering its innovative CA8* (*Carbonic anhydrase-8-like analgesic peptides, CA8 variants) gene therapies, using a state-of-the-art replication-defective disease-free HSV vector (rdHSV-CA8*). This issued patent and patent family, as well as the underlying CA8*-related technology were licensed in 2023 by Adolore BioTherapeutics from the University of Miami, Miami, FL.

"The issuance of this patent establishes a proprietary position for Adolore's highly innovative approach for treating chronic pain," commented Roelof Rongen, CEO of Adolore. "We continue to believe in the potential of this platform and building the intellectual property protection for our CA8* gene therapies is a key first-step as we progress toward clinical testing and commercialization of these novel and potentially transformational therapies."

"This important patent covers a range of CA8 variants, both as novel composition of matter as well as their novel uses, and includes technology, which holds the potential to minimize unwanted effects of avoiding biodistribution of our novel gene therapies to unaffected healthy tissues," said Dr. Roy Levitt, Inventor and Founder/Chairman of Adolore. "There is a significant and growing need to provide an alternative to the currently available and widely used oral opioid pain treatments that can adversely impact the entire body. These oral opioid-based treatments are systemic, short-acting and complicated by dependence, tolerance, abuse, addiction, death and diversion. We continue to develop our innovative approach to potentially address the significant unmet need for safe and effective locally acting pain therapies to replace opioids; and our preclinical data strongly support progression toward the clinics with continued development."

There are currently very few safe, efficacious non-opioid analgesic treatments for chronic pain on the market, leaving a large and very urgent unmet medical need. Leveraging its innovative CA8* gene therapy, Adolore is currently advancing two preclinical development programs, ADB-101 for the treatment of genetically-determined life-long recurrent severe neuropathic pain due to erythromelalgia an orphan disease where there are no approved therapies; and ADB-102 for the treatment of patients with chronic pain caused by knee OA. Based on compelling data generated to date, the Company is progressing these programs toward an IND filing and first-in-human clinical studies.

The Company's development program for the treatment of chronic pain in knee osteoarthritis is supported by a UG3/UH3 grant awarded to the University of Miami by NIH/NINDS HEAL program to support all formal pre-clinical GLP/GMP/GCP development work through a first-in-human study in patients expected to commence in 2026.

Published on : 07th March, 2024