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

The efficacy and safety of XG005, a novel non-opioid chemical entity concurrently inhibiting both nociceptive and neuropathic signals, in managing post-operative pain: a randomized, placebo-controlled phase 2b trial (PAINWeek 2025) - P2/3 | "XG005 is a single molecule conjugating naproxen and pregabalin, which is not active in gastrointestinal tract and thus minimizes naproxen side effects compared with administering naproxen directly...Qualified subjects were randomized (1:1:1) to receive either 1250 mg or 750 mg of XG005 tablets, or placebo...Tramadol consumption in the placebo group was 4.1- or 3.0-fold more than in the 1250 mg or 750 mg groups over 72 hours, and those were 3- or 2.5-fold in acetaminophen consumption...In comparison with other analgesics to treat acute pain using the same bunionectomy model with the same efficacy endpoint (SPI48) or Summed Pain Intensity Difference at 48 hours (SPID48), the pooled mean effect sizes are: 0.59 with various NSAIDs, 0.52 with various opioids combination with either acetaminophen or NSAIDs, 0.88 with tapentadol (an opioid) and 0.36 with a Nav1.8 antagonist... This trial randomized 450 participants (median age, 48 years; 80% female) with comparable..."

Clinical • P2b data • Addiction (Opioid and Alcohol) • CNS Disorders • Neuralgia • Pain • Psychiatry • Sleep Disorder • NAV1

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