Oral presentation highlights additional data from PROGRESS Phase 2b study of pilavapadin supporting selection of 10mg as optimal dose for Phase 3 development in DPNP
New data on spasticity further validates the broader potential importance of the AAK1 pathway in neurologic diseases
THE WOODLANDS, Texas, April 17, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that results from its PROGRESS Phase 2b study of pilavapadin in diabetic peripheral neuropathic pain (DPNP) supporting the selection of pilavapadin 10 mg as the optimal dose for Phase 3 development will be presented on Wednesday April 22, during the American Academy of Neurology (AAN) Annual Meeting. At the meeting, the company will also present results of an evaluation of pilavapadin on spasticity-related endpoints in preclinical models of multiple sclerosis and spinal cord injury. The congress is being held April 18-22 in Chicago, Illinois.
In a session titled “Additional Efficacy Data Support Selection of Pilavapadin 10 mg for Phase 3 Development in DPNP: Results From PROGRESS,” Suma Gopinathan, Ph.D., Senior Vice President of Discovery at Lexicon, will present data from the study on pain outcomes as measured by the Brief Pain Inventory–Diabetic Peripheral Neuropathy (BPI-DPN) patient reported instrument. Pilavapadin 10 mg achieved a nominally significant reduction in Average Pain at Week 8 versus placebo, with concordant improvements in Worst and Least Daily Pain, as measured by BPI-DPN. The 10 mg dose was generally well-tolerated over 8 weeks, with completion rates comparable to placebo and few discontinuations due to treatment emergent adverse events (TEAEs). Overall, these results provide additional support for the advancement of pilavapadin 10 mg into Phase 3 evaluation in DPNP.
“We appreciate the opportunity to present additional efficacy data from the PROGRESS study to the neurology community,” said Dr. Gopinathan. “These results demonstrate that pilavapadin 10 mg achieved a meaningful reduction in average pain at Week 8, with consistent improvements across other pain measures, supporting its advancement into Phase 3 development in diabetic peripheral neuropathic pain.”
Presentation details:
- Additional Efficacy Data Support Selection of Pilavapadin 10mg for Phase Three Development in DPNP: Results From PROGRESS – Wednesday, April 22, at 12:03 p.m. CT, presentation S38.005. Session S38: Pain. Presented by Suma Gopinathan, Ph.D.
During AAN, Lexicon also will present data from studies evaluating pilavapadin on spasticity endpoints in preclinical models of multiple sclerosis and spinal cord injury.
Poster details:
- Preclinical Evidence Supporting Pilavapadin as a Novel Oral Therapy for Spasticity -- Monday, April 20, 8:00-9:00 a.m. CT, presentation P4010. Session Multiple Sclerosis: Clinical Science 1. Presented by Suma Gopinathan, Ph.D.
About Pilavapadin
Pilavapadin is a potent, once-daily, orally administered, selective investigational small-molecule inhibitor of AP2-associated kinase 1 (AAK1), a novel target for neuropathic pain. Discovered using Lexicon’s unique gene science approach through the Genome5000™ program, AAK1 was identified as a promising target for the treatment of neuropathic pain. Preclinical studies showed that pilavapadin penetrates the central nervous system and reduces pain behavior across multiple neuropathic pain models, without affecting opioid pathways.
About the PROGRESS Study
The PROGRESS study commenced in December 2023 and enrolled 496 adult patients with a diagnosis of diabetes (type 1 or type 2) and moderate to severe DPNP. The study was placebo-controlled with a primary endpoint of change from baseline to Week 8 in average daily pain score (ADPS) as compared to placebo and evaluated three treatment groups receiving once daily pilavapadin doses of 10 mg, 20 mg or 20 mg for seven days followed by 10 mg thereafter. Study design permitted patients to remain on one stable-dose DPNP therapy (e.g. gabapentin, pregabalin or duloxetine) without withdrawing from therapies that, although inadequate, may have provided some benefit – aligning with how new DPNP drugs are likely to be used in practice.
About Diabetic Peripheral Neuropathic Pain (DPNP)
DPNP is a debilitating chronic complication of diabetes which can result in burning pain, numbness, and other symptoms in the hands, feet, legs and arms. There are approximately 9 million patients in the U.S. who are suffering with DPNP.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
