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Dr. Roy Levitt, Executive Chairman of Adolore BioTherapeutics, Presented at the Next Generation Gene Therapy Vectors Summit

DELRAY BEACH, FL / ACCESS Newswire / August 12, 2025 / Adolore BioTherapeutics, Inc., (“Company” or “Adolore”) announced that Roy Clifford Levitt, MD, Clinical Professor at the University of Miami, Principal Investigator and Program Director of the NIH, NINDS, HEAL UH3 Award supporting ADB-102 development for the treatment of chronic knee pain due to osteoarthritis, (“OA”), and founder and Executive Chairman of Adolore presented the Company’s breakthrough non-opioid gene therapy programs for chronic pain at the Next Generation Gene Therapy Vectors Summit on July 31, 2025 in Boston.

Dr. Levitt presented the latest safety and efficacy data on Adolore’s replication defective, disease-free, HSV viral vectors during his talk entitled: “Rethinking Vector Choice: Utilizing Optimized HSV to Enhance Safety & Efficacy”. He presented evidence of long-lasting (>7 months), profound analgesia (equivalent to high doses of opioids) for their HSV gene therapy with regional administration (single intra-articular knee joint injection) in model systems. Additional data demonstrated excellent cellular tropism (neuronal specificity), biodistribution, and shedding characteristics. Dr. Levitt also highlighted how regional administration minimizes off-target effects, improving safety, efficacy, and minimizes immunogenicity.

Adolore is advancing two preclinical development programs: a lead program for knee pain due to OA and a program for erythromelalgia, (“EM”), an orphan neuropathic pain indication for which there are no FDA-approved treatments. EM is a rare, heritable, chronic and debilitating pain disease.

In model systems, replication-defective, disease-free, herpes simplex virus (rdHSV) gene therapy expressing an analgesic carbonic anhydrase-8 (CA8*) peptide variant corrects somatosensory hyperexcitability by activating Kv7 voltage-gated potassium channels, thereby producing profound, long-lasting analgesia. Adolore has achieved proof-of-concept in animal models, validating the mechanism of action in knee pain from OA and EM.

About Adolore BioTherapeutics, Inc.

Adolore BioTherapeutics, Inc., is a biotechnology company focused on developing novel therapies for treating chronic pain using a revolutionary intra-cellular replication-defective HSV (rdHSV) drug delivery platform that is disease-free, non-toxic, and permits localized peripheral nervous system delivery of proprietary biotherapeutics. This rdHSV gene therapy technology incorporates an established re-dosing strategy and an excellent safety profile. HSV vectors are known for their stability and prolonged gene expression, providing an excellent basis for the long-term treatment of chronic pain conditions and neurological disorders. Our best-in-class CA8* programs are long-acting, locally acting gene therapies that are opioid-free Disease-Modifying Anti-Pain therapies (DMAPs) designed to treat many forms of chronic pain as well as therapies for epilepsy and hearing loss.

Leveraging its innovative gene therapy vectors expressing CA8* analgesic peptides (ADLR-1001), Adolore is currently advancing two preclinical development programs: ADB-101 for the treatment of patients’ chronic pain caused by erythromelalgia, an orphan disease, and ADB-102, their lead program for the treatment of patients with chronic pain caused by knee OA. Based on substantial compelling preclinical data generated to date, the Company is progressing these programs toward IND filings and first-in-human clinical studies. Adolore has two additional programs available for partnering: ADB-104 for Drug-Resistant Refractory Focal Epilepsy, ADB-105 for Acute Severe Hearing Loss and ADB-106 for Chronic Eye Pain.

For more information, visit adolore.com.

Forward-Looking Statements

To the extent this announcement contains information and statements that are not historical, they are forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “will,” “should,” “may,” “plan,” “intend,” “assume” and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, some of which are beyond the control of the Company. These risks and uncertainties include, but are not limited to, those associated with drug development. These risks, uncertainties, and other factors may cause the actual results, performance, or achievements of the Company to be materially different from the anticipated future results, performance, or achievements expressed or implied by the forward-looking statements.

Investor Relations Contact

Paul Barone (215) 622-4542
pbarone@adolore.com

SOURCE: Adolore Biotherapeutics, Inc.

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