DIMERx Appoints Former FDA Division Director Dr. Lee S. Simon As Chief Advisor For Clinical Development And Regulatory Strategy

DIMERx, Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer-based therapeutics for significant public health challenges, announced the appointment of Lee S. Simon, MD, as Chief Advisor for Clinical Development and Regulatory Strategy. Dr. Simon previously served as Director of the FDA’s Division of Analgesic, Anti-Inflammatory and Ophthalmologic Drug Products, bringing deep regulatory and clinical expertise to the company.

In this advisory role, Dr. Simon will guide DIMERx’s clinical development plans and regulatory engagements, with an initial focus on DMX-101, the company’s lead analgesic candidate. DMX-101 is a Phase 2/3-ready, peripherally acting buprenorphine dimer designed to provide strong pain relief without addiction risk, respiratory depression, or central nervous system side effects. Development of DMX-101 is further supported by a grant of up to $15 million from the National Institute on Drug Abuse (NIDA) through the NIH HEAL Initiative.

Nikhilesh “Nik” Singh, PhD, Co-Founder and Chief Executive Officer of DIMERx, said the company is pleased to welcome Dr. Simon during an important stage of growth. He also acknowledged Jeffrey W. Sherman, MD, FACP—an investor, advisor, and Chief Medical Officer Emeritus of Horizon Therapeutics—for facilitating the introduction. Singh noted that Dr. Simon’s extensive experience in clinical practice, drug development, and regulatory decision-making will be essential as the company advances DMX-101 and strengthens its broader dimer-based therapeutic platform. His expertise is expected to support the design of efficient, approvable clinical trials and foster productive communication with the FDA and other regulatory bodies as DIMERx works to bring non-addictive pain treatments to patients.

Dr. Simon expressed his enthusiasm for joining DIMERx, noting that the company is addressing a critical unmet need in medicine: delivering effective treatment for moderate-to-severe pain without contributing to opioid addiction. He highlighted that DMX-101 is backed by strong scientific evidence and human data, and he looks forward to helping chart a clear development and regulatory pathway that will enable this novel peripherally acting analgesic to reach patients as quickly and safely as possible.