naproxen/pregabalin oral (XG005 oral) / Xgene Pharma - LARVOL DELTA

XG005 synchronizes inhibition of both nociceptive and neuropathic pain in osteoarthritis of the knee (EULAR 2025) - " The Phase 2b trial (2021LP01217) was a randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study evaluating the safety and efficacy of XG005 tablets in Chinese patients with knee OA... XG005 treatments resulted in significant relief of OA symptoms. Patients with neuropathic pain, female, patients with more severe pain, shorter OA history or elder age had greater responses to XG005 treatment. This non-opioid molecule blocking both nociceptive and neuropathic pain represents a promising and more efficacious treatment for chronic OA with mixed phenotypes."

Immunology • Neuralgia • Osteoarthritis • Pain • Rheumatology

XG005 for Pain Control in Subjects Undergoing Bunionectomy (clinicaltrials.gov) - P2/3 | N=450 | Completed | Sponsor: Xgene Pharmaceutical Group | Recruiting ➔ Completed | Trial primary completion date: May 2024 ➔ Sep 2024

Trial completion • Trial primary completion date • Pain

A Novel Non-Opioid Multimodal Analgesic from Xgene Pharmaceutical Reduces Pain and a Need for Opioid Consumption in a Post-Surgical Pain Trial (Businesswire) - P2b/3 | N=450 | NCT06017999 | Sponsor: Xgene Pharmaceutical Group | "Xgene Pharmaceutical announced additional insights into the positive results of a multiple-center, placebo-controlled, dose-ranging Phase 2b study...in patients undergoing bunionectomy, evaluating the safety and efficacy of the XG005 oral tablet on acute pain....Treatment with XG005 resulted in statistically significant and clinically meaningful reduction in post-surgical pain following bunionectomy compared to placebo. XG005 eliminated the need to use any rescue pain medication in 42% of patients in a high dose group and in 33% of patients in a low dose group. For those patients who required rescue analgesics, XG005 increased the time to first use of rescue by 8-fold and it reduced the total amount of opiate consumption medication by 4-fold in a high dose group. Patient Global Assessment of pain control was statistically better in XG005 treatment arms than in the placebo group over 72 hours."

P2b data • Pain

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging and Parallel-group Study to Evaluate the Safety and Efficacy of XG005 in Subjects with Painful Osteoarthritis of the Knee (ACR Convergence 2024) - "XG005 tablets demonstrated robust and consistent efficacy in relieving symptoms of OA with good tolerability. The non-opioid, dual mechanistic action of blocking both nociceptive and neuropathic pain distinguishes XG005 from other analgesics. These results strongly suggest that XG005 represents a promising, more efficacious, and safer addition to chronic OA management."

Clinical • Late-breaking abstract • P2b data • CNS Disorders • Depression • Immunology • Insomnia • Mood Disorders • Neuralgia • Osteoarthritis • Pain • Psychiatry • Rheumatology • Sleep Disorder