Topline Results for Phase 2b PROGRESS Study of Pilavapadin (LX9211) in Diabetic Peripheral Neuropathic Pain: Moving Forward to Phase 3 Development
The pharmaceutical industry recently announced the release of the topline results from the Phase 2b PROGRESS study of Pilavapadin (LX9211), an investigational drug developed by Lexicon Pharmaceuticals, for the treatment of Diabetic Peripheral Neuropathic Pain (DPNP).
About Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain (DPNP) is a common and debilitating complication of diabetes, affecting approximately 50% of patients with diabetes. This condition is characterized by pain, numbness, and tingling sensations in the feet and legs, which can lead to significant impairment in daily activities and reduced quality of life.
The PROGRESS Study
The PROGRESS (Pilavapadin in Diabetic Peripheral Neuropathic Pain: A Randomized, Double-blind, Placebo-controlled Study) study was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and efficacy of Pilavapadin in the treatment of DPNP. The study enrolled 468 patients with diabetes and DPNP, who were randomized to receive either Pilavapadin 10 mg or placebo twice daily for 12 weeks.
Topline Results
The topline results of the PROGRESS study showed that Pilavapadin significantly reduced pain in patients with DPNP, as measured by the average change from baseline in pain score on the 11-point Numeric Rating Scale (NRS). Specifically, the mean change from baseline in pain score in the Pilavapadin group was -1.1 points, compared to -0.4 points in the placebo group (p<0.001).
Additionally, Pilavapadin was generally well-tolerated, with a safety profile consistent with previous studies. The most common adverse events were gastrointestinal in nature, including diarrhea and nausea, which occurred in approximately 20% of patients in the Pilavapadin group and 15% of patients in the placebo group.
Impact on Individuals with Diabetes
The results of the PROGRESS study are particularly noteworthy for individuals with diabetes and DPNP, as there is currently a lack of effective treatments for this condition. Pilavapadin’s ability to significantly reduce pain in patients with DPNP represents a promising advancement in the management of this debilitating complication.
Impact on the World
The successful completion of the Phase 2b PROGRESS study and the advancement of Pilavapadin into Phase 3 development also has broader implications for the world. Diabetes is a global health concern, with an estimated 463 million people living with the condition worldwide. Approximately half of these individuals are expected to develop DPNP during the course of their disease, leading to significant morbidity and healthcare costs.
The development of effective treatments for DPNP, such as Pilavapadin, has the potential to significantly improve the quality of life for millions of people with diabetes and reduce the burden on healthcare systems.
Conclusion
The topline results of the Phase 2b PROGRESS study represent an important step forward in the development of Pilavapadin as a potential treatment for Diabetic Peripheral Neuropathic Pain. The significant reduction in pain observed in patients with DPNP, along with its generally favorable safety profile, support the advancement of Pilavapadin into Phase 3 development. The potential impact of this development on individuals with diabetes and the broader healthcare community is significant, and the successful completion of Phase 3 trials and regulatory approval would represent a major advancement in the management of this debilitating complication.
- Phase 2b PROGRESS study of Pilavapadin (LX9211) for DPNP shows significant reduction in pain
- Pilavapadin generally well-tolerated with gastrointestinal adverse events
- Advancement into Phase 3 development represents a promising advancement in DPNP treatment
- Impact on individuals with diabetes and healthcare systems significant
