DIMERx Appoints Lee S. Simon, MD as Chief Advisor for Clinical Development & Regulatory Strategy
Veteran FDA and Industry Leader to Guide Late-Stage Programs, Including First-In-Class Non-Addictive Analgesic DMX-101
SAN FRANCISCO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- DIMERx, Inc. (“DIMERx”), a clinical-stage biopharmaceutical company developing first-in-class dimer-based therapeutics for major public-health needs, today announced the appointment of Lee S. Simon, MD, former Director of the FDA’s Division of Analgesic, Anti-Inflammatory and Ophthalmologic Drug Products, as Chief Advisor for Clinical Development and Regulatory Strategy.
In this role, Dr. Simon will provide strategic advisory leadership across DIMERx’s clinical programs and regulatory interactions, with an initial focus on DMX-101, the company’s Phase 2/3-ready, peripherally acting buprenorphine dimer designed to deliver potent pain relief without addiction, respiratory depression, or central nervous system adverse effects. The DMX-101 program is supported by a grant of up to $15 million awarded by NIDA under the NIH HEAL Initiative.
“We are honored to welcome Dr. Lee Simon as Chief Advisor at a pivotal time for DIMERx,” said Nikhilesh (“Nik”) Singh, PhD, Co-Founder and Chief Executive Officer of DIMERx. “We are also grateful to Jeffrey W. Sherman, MD, FACP - a DIMERx investor and advisor, and CMO Emeritus of Horizon Therapeutics - for making this introduction. Dr. Simon’s deep experience at the intersection of clinical medicine, drug development, and regulatory decision-making will be instrumental as we advance DMX-101 and our broader dimer platform. His guidance will help us design efficient, approvable trials and engage constructively with the FDA and other regulators as we work to deliver non-addictive pain solutions to patients in need.”
“DIMERx is addressing one of the most urgent unmet needs in medicine: how to treat moderate-to-severe pain without perpetuating the cycle of opioid addiction,” said Dr. Lee S. Simon. “The DMX-101 program is supported by science and human data, and I am excited to work with the DIMERx team to shape a development and regulatory path that can bring this novel, peripherally acting analgesic to patients as efficiently as possible.”
About DIMERx, Inc.
DIMERx, Inc. is a clinical-stage biopharmaceutical company developing first-in-class, covalently linked dimer-based therapeutics to address major public-health challenges in pain management and the opioid crisis. Supported by significant non-dilutive funding and strategic collaborations, DIMERx is building a pipeline of innovative dimer-based candidates targeting pain and other serious conditions with high unmet medical need.
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
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
