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DIMERx Awarded Up to $15M by NIDA Under NIH HEAL Initiative® to Advance DMX-101 as a Non-Addictive Oral Therapy for Chronic Pain

The Award Highlights the Promise of Exclusively Targeting Peripheral Opioid Receptors to Treat Chronic Pain Without the Risk of Addiction and Dependence

SAN FRANCISCO, June 25, 2025 (GLOBE NEWSWIRE) -- DIMERx, Inc., a late-stage biopharmaceutical company entering growth phase, today announced it has been awarded a UG3/UH3 cooperative agreement (UG3DA061645) for up to $15 million from the National Institute on Drug Abuse (NIDA) to advance its lead drug candidate, DMX-101, as a non-addictive oral therapy for chronic lower back pain.

The grant was awarded through the NIH Helping to End Addiction Long-term® Initiative, a trans-agency effort aimed at speeding solutions to the opioid overdose crisis, accelerating the development of non-addictive pain therapies and reducing reliance on traditional, centrally acting opioids.

In 2023, over 52 million U.S. adults suffered from chronic pain. While centrally-acting opioids remain a common treatment, up to 29% of patients misuse them, and as many as 12% develop addiction-related disorders—many progressing to heroin or fentanyl use. Restrictions on prescribing centrally-acting opioids have reduced access to effective pain relief and driven many patients toward illicit alternatives—leaving them stigmatized, isolated, and underserved. We believe the solution lies in non-addictive analgesics that treat pain at its source without affecting the brain. DIMERx is advancing DMX-101, a novel, peripherally acting buprenorphine dimer with analgesic and anti-hyperalgesic properties designed to relieve chronic pain without the risk of addiction and dependence.

“We are honored to receive this important award from NIDA under the NIH HEAL Initiative, given the devastating impact of abuse and addiction caused by centrally-acting opioids on our society, public health, and national well-being,” said Nikhilesh Singh, MPharm, PhD, CEO of DIMERx. “We appreciate that NIDA recognizes the therapeutic potential of targeting peripheral opioid receptors and the promise of DMX-101 to provide effective, non-addictive pain relief. This support reinforces our mission to advance innovative therapies to treat pain without the risks of addiction and dependence consistent with national healthcare priorities.”

“Throughout my career in pain medicine, I’ve long understood the potential of peripheral opioid receptors, but it’s been unclear why the pharmaceutical industry has not fully leveraged this mechanism through innovative medicinal chemistry strategies,” said Dr. Lynn Webster, a clinical advisor to DIMERx, author of The Painful Truth and a past president of the American Academy of Pain Medicine. “DMX-101 has the potential to be a true breakthrough—addressing both chronic pain and the addiction crisis. I am excited to work with the DIMERx team to advance this therapy and bring relief to patients.”

“As lead investigator on the Phase 2a study in IBS-D, I’ve observed that DMX-101 may offer a potential new approach for managing chronic abdominal pain—a symptom with limited effective, non-addictive treatment options,” said Dr. Anthony Lembo, Vice Chair of Research at Cleveland Clinical Digestive Disease Institute. “Early data also suggest potential for broader applications across other pain indications.”

About DIMERx, Inc.

DIMERx is a clinical-stage biopharmaceutical company pioneering a proprietary dimer technology platform to develop novel chemical entities for high-impact, underserved medical conditions. Co-founded by Gregory Beyer, Harvinder Dhani, and Nikhilesh Singh, PhD, the company also collaborates closely on clinical strategy with Maurizio Fava, MD, Chair, Mass General Brigham Academic Medical Centers Psychiatry Department.

The company’s lead asset, DMX-101, is a covalently modified, chemically stable, halogen-free buprenorphine dimer (CAS No: 1820753-68-1) that acts peripherally at the source to provide non-addictive pain relief. DMX-101 is in phase 2 clinical development for chronic lower back pain. Across Phase 1 and Phase 2a studies involving over 400 human subjects and patients, it has demonstrated a favorable safety profile—including pancreatic safety—and clear analgesic benefits.

DIMERx’s second program, DMX-201, is a covalently linked dimer of arginine and agmatine—a next-generation nitric oxide (NO) donor being developed for conditions involving endothelial dysfunction, such as vaso-occlusive crisis (VOC) pain in sickle cell disease, where treatment options remain dominated by centrally acting opioids. Learn more at www.dimerx.com.

About the NIH HEAL Initiative

The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an NIH-wide effort to speed scientific solutions to stem the national opioid overdose public health emergency and crisis of chronic pain. Almost every NIH Institute and Center is accelerating research to address this public health emergency from all angles. Learn more at https://heal.nih.gov.

Contacts

Gregory Beyer, Co-Founder, CFO/COO

investors@dimerx.com

or

Laurence Watts, New Street Investor Relations

laurence@newstreetir.com


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