The experimental, non-opioid, oral agent XG005 inhibits inflammatory and neuropathic signals in patients with knee osteoarthritis (OA). In a phase 2b trial, XG005 demonstrated robust and consistent efficacy in alleviating OA symptoms and was well tolerated, making this a promising treatment option for chronic OA.
XG005 is a non-opioid, dual-acting conjugated prodrug in development in oral and topical formulations. It inhibits inflammatory and neuropathic signals via the COX enzymes and the calcium subunit. Dr. Leon Jiang, Xgene Pharmaceutical Lexington, in Massachusetts, presented the results of a randomized, double-blind, placebo-controlled, phase 2b trial evaluating oral XG005 for Chinese patients with knee OA1. The 318 participants, recruited from 22 sites, had moderate-to-severe OA pain and Kellgren-Lawrence (KL) grade II–III. The patients were randomized 2:1:2 to XG005 750 mg twice daily, 500 mg twice daily, or placebo. The primary efficacy endpoint changed from baseline in weekly Average Daily Walking pain after 4 weeks.
Average daily walking pain and Western Ontario and McMaster Universities Arthritis (WOMAC) index pain at baseline were 5.87 and 4.59, respectively, on a numerical scale of 0–10; Knee Injury and Osteoarthritis Outcome Score (KOOS) was 52.46. Almost half (43.2%) of the participants had painDETECT scores less than or equal to 13, indicating neuropathic pain components.
At week 4, Weekly Average Daily Walking pain in the XG005 750 mg group was significantly more reduced than in the placebo group: -2.3 versus -1.7 (P=0.0055). This difference was already significant after 1 week (P=0.0025). On the WOMAC Pain subscore, both doses of XG005 were significantly more effective compared with placebo: -2.2 (for both doses) versus 1.7 (750 mg: P=0.0054; 500 mg: P=0.0384). Both doses of XG005 were also superior to placebo in all other secondary efficacy endpoints. XG005 was safe and well-tolerated, with no drug-related serious AEs. Rescue medication was barely used in the treatment or placebo arms.
Medical writing support was provided by Michiel Tent
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