Adolore BioTherapeutics Unveils Strategy for Next-Gen Non-Opioid Gene Therapies for Chronic Pain

Adolore BioTherapeutics, a biotechnology company specializing in opioid-free gene therapy treatments for chronic pain, has provided an update on their recent development progress and business outlook. Located in Delray Beach, FL, Adolore is advancing its innovative CA8* gene therapy (ADLR-1001) through two primary preclinical programs: ADB-101 for erythromelalgia-related chronic pain and ADB-102 for chronic knee pain caused by osteoarthritis (OA).

Adolore's approach to treating chronic pain hinges on two key innovations. First, CA8* is a novel therapeutic protein with the potential to benefit millions of chronic pain sufferers, distinguishing it from other gene therapies that typically serve smaller patient populations with rare genetic disorders. CA8* functions as a potent non-opioid analgesic protein within sensory neurons, bypassing the complications associated with opioid treatments. Second, Adolore's highly bio-engineered, replication-defective HSV-derived vector intracellular delivery system (rdHSV) selectively targets pain sensory cells while evading the immune system. This localized delivery approach has shown a benign side-effect profile in preclinical studies, contrasting sharply with the highly immunogenic AAV vectors commonly used for gene therapies.

The development program for treating chronic knee pain in OA is fully funded through a UG3/UH3 grant awarded by the NIH/NINDS HEAL program, supporting the first-in-human clinical study. Adolore is also advancing IND-enabling studies for ADLR-1001 gene therapy, with additional translational data expected by year-end. Plans for data presentations at significant scientific congresses and publications in leading journals are scheduled throughout 2024.

Adolore is also scaling up its manufacturing process and producing the initial GMP batch for human clinical studies. The company continues to expand its patent estate across its pipeline. The NIH/NINDS has awarded the UH3 HEAL CDMO contract to Advance Biological Laboratories (ABL) in Rockville, MD, for developing the scale-up manufacturing process and producing the initial GMP batch for human clinical studies. Adolore is currently conducting its technology transfer and initiating process and method development work at ABL, aiming to develop GMP-grade processes and testing methods in 2024. This will enable the production of toxicology and clinical batches in 2025. ABL's work will support the Company’s IND filing for osteoarthritis, expected in the first half of 2026. Additionally, Adolore is conducting further preclinical animal studies, with results anticipated later in 2024.

Adolore, supported by the NINDS HEAL Program, is dedicated to providing promising alternatives to opioid analgesics, especially given the widespread opioid crisis. Scientific findings and intellectual property progress are also noteworthy. Dr. Roy Clifford Levitt, a key figure at the University of Miami and Adolore, has submitted manuscripts detailing the mechanism of action, efficacy, and safety of ADLR-1001 in preclinical studies. These findings demonstrated that ADLR-1001 decreased pain-sensing neuronal excitability by activating Kv7 voltage-gated potassium channels, a recognized therapeutic target for chronic pain treatment, including erythromelalgia. Additional publications are expected in prominent peer-reviewed scientific journals in 2024.

Adolore has also advanced its intellectual property portfolio, with the issuance of its first U.S. patent (U.S. patent No. 11,911,450) covering its innovative CA8* gene therapy technology, licensed from the University of Miami. This patent, along with the pending patent application family, is projected to expire in 2041. Additionally, Adolore has received a patent allowance in Korea for its Vector/Cell system patents, licensed from the University of Pittsburgh, and anticipates further allowances in key markets globally.

Financially, Adolore has raised an additional $1.0 million, bringing the total to $2.5 million in convertible debt. The company expects these funds to support operations through mid-2026.

Adolore BioTherapeutics remains committed to developing novel therapies for chronic pain, aiming to provide alternatives to opioid analgesics and address various pain and nervous system conditions. The company’s CA8* gene therapy programs are in preclinical development, targeting conditions such as erythromelalgia and knee osteoarthritis, contributing to the ongoing efforts to mitigate the opioid crisis.