Development program for the treatment of osteoarthritis (OA) chronic knee pain is fully funded through the first-in-human clinical study by a UG3/UH3 grant awarded by NIH/NINDS HEAL program

Ongoing progress with IND-enabling studies of ADLR-1001 gene therapy for the treatment of OA chronic knee pain; Additional translational data expected before year-end

Plans for data presentations at prominent scientific congresses and publications in premier journals expected throughout 2024

Scale-up of manufacturing process and production of the initial GMP batch for use in human clinical studies underway

Company continues to expand patent estate across pipeline

DELRAY BEACH, FL / ACCESSWIRE / May 21, 2024 / Adolore BioTherapeutics ("Adolore" or the "Company"), a biotechnology company focused on developing breakthrough opioid-free gene therapy treatments for chronic pain, today outlined recent pipeline development progress and provided a business outlook.

Leveraging its innovative CA8*(*Carbonic anhydrase-like analgesic peptides, CA8 variants) gene therapy (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 our lead program for the treatment of patients with chronic pain caused by knee OA, ADB-102. Based on compelling preclinical data generated to date, the Company is progressing these programs towards IND filings and first-in-human clinical studies.

Adolore's highly differentiated approach to treating chronic pain is based on two key innovative aspects:

• CA8* is a novel therapeutic protein that has the potential to benefit many millions of patients suffering from chronic pain, this in contrast to many other gene-therapy products that are often limited to serving just thousands of patients with rare genetic-defects. CA8* is an endogenous and potent non-opioid analgesic protein that acts within the sensory neuron and avoids the complications of opioids.
• Additionally, the Company's highly bio-engineered replication-defective HSV-derived vector intracellular delivery system (rdHSV) is highly selective for the targeted pain sensory cells and evades the immune system. With is strictly local delivery approach, Adolore has been able to observe a benign side-effect profile in our preclinical studies, which the Company expects to translate into patients treated with ADLR-1001. This benign safety profile stands in stark contrast with the highly immunogenic AAV vectors that are currently most widely used for delivery of gene-therapies.

"We continue to advance the development of our non-opioid analgesic gene therapies for the treatment of chronic pain and execute the most expedient path toward the clinic. While we are initially focused on our lead program, ADB-102 for chronic knee pain due to OA, we are also laying the groundwork for the use of our CA8*-products in other chronic pain indications including hip OA, Erythromelalgia (an Orphan Drug disease), diabetic neuropathy, post-herpetic neuralgia, and cancer pain among many other chronic pain conditions," commented Roelof Rongen, Chief Executive Officer of Adolore. "We are highly confident about the development advancements we will make in 2024 and 2025 and look forward to providing continued updates."

Therapeutic Development Update

The initial stage of the Company's development program for the treatment of chronic pain in knee osteoarthritis is fully funded by the NIH/NINDS HEAL UH3 Award to the University of Miami that supports all formal pre-clinical GLP/GMP/GCP development work, as well as a first-in-human clinical study in knee OA patients expected to commence in 2026.

The NIH/NINDS awarded the UH3 HEAL CDMO contract to Advance Biological Laboratories (ABL, a subsidiary of Institute Merieux) in Rockville, MD for the development of the scale-up manufacturing process and production of the initial GMP batch for use in human clinical studies. Adolore is currently conducting its technology transfer, as well as facilitating the initiation of process and method development work at ABL, with the goal of developing the GMP-grade process and testing methods in 2024. This will enable production of toxicology and clinical batches in 2025. ABL's work will provide formal GLP-toxicology study drug and support the Company's IND filing for osteoarthritis, expected to take place in the first half of 2026. Adolore is also conducting additional pre-clinical animal studies, expected to read out later in 2024.

The Company is grateful for the recognition by and support from the NINDS HEAL Program of its very versatile gene therapy technology for the treatment of chronic pain in the NIH's quest to support promising alternatives to opioid analgesics. Given the absence of better options, opioids are currently some of the most widely prescribed classes of pain medications and the cause of the widespread ongoing opioid crisis.

Scientific Publications and Intellectual Property

Roy Clifford Levitt, MD, Clinical Professor at the University of Miami, Principal Investigator and Program Director of the NIH, NINDS, HEAL Award supporting ADLR-1001 development for the treatment of chronic knee pain due to OA, and Founder & Executive Chairman of Adolore BioTherapeutics, recently submitted two manuscripts covering the mechanism of action, efficacy and safety of ADLR-1001 in preclinical studies. These findings included electrophysiological data demonstrating ADLR-1001 decreased pain-sensing neuronal excitability by activating Kv7 voltage-gated potassium channels (published earlier this month in Frontiers in Molecular Neuroscience). Kv7 channel activation is an accepted therapeutic target for treating chronic pain, including erythromelalgia. Additional publications of efficacy and safety data are expected in prominent peer-reviewed scientific journals in 2024. Moving forward, Adolore remains committed to generating a robust portfolio of scientific reports documenting the exceptional safety and efficacy of ADLR-1001.

Additionally, the Company has made notable progress with advancing its intellectual property portfolio. As recently announced, the first U.S. patent covering its innovative CA8* gene therapy (U.S. patent No. 11,911,450) was issued. This patent and pending patent application family, covering the underlying CA8* gene therapy technology were licensed in 2023 by Adolore BioTherapeutics from the University of Miami, Miami, FL. The U.S. Patent and Trademark Office ("USPTO") granted 949 days of patent term restauration for the ‘450 patent which the USPTO projects will expire now in 2041.

On the Vector/Cell system patents (licensed from the University of Pittsburgh), Adolore recently received a patent allowance in Korea and expects additional allowances in key markets around the world going forward. A U.S. patent has already been granted for the Vector/Cell system patent family.

Financial Update

On the financing front, the Company has raised additional cash of $1.0 million, bringing the total to $2.5 million in convertible debt raised so far. Based on management's current planning and expectations, the Company expects its cash reserves to fund operations through mid-2026.

For more information, visit adolore.com and stay up to date with Adolore's latest news and events, connect with the Company on LinkedIn, Facebook and Twitter.

About Adolore BioTherapeutics, Inc.

Adolore BioTherapeutics, Inc., is a biotechnology company focused on developing novel therapies for the treatment of chronic pain and other pain and nervous system conditions or disorders. Our best-in-class 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.

The Company's current CA8* gene therapy programs are in preclinical development for treatment of patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and chronic pain due to knee osteoarthritis, affecting a large number of patients that are often treated with opioids due to the lack of good alternatives, thus contributing to the ongoing opioid crisis.

For more information, visit adolore.com.

Forward Looking Statements

To the extent this announcement contains information and statements that are not historical, they are considered 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

JTC Team, LLC
Jenene Thomas
833-475-8247
adolore@jtcir.com

SOURCE: Adolore Biotherapeutics, Inc.