Analgesic from Xgene Pharmaceutical Reduces Pain and Opioid Use in Post-Surgical Trial
Xgene Pharmaceutical has revealed further findings from a positive, multi-center, placebo-controlled, dose-ranging Phase 2b study (registration number: NCT06017999) evaluating the safety and efficacy of its XG005 oral tablet in patients undergoing bunionectomy surgery. The trial, which focused on acute pain management, demonstrated promising results, showing that XG005 significantly improves pain relief while reducing opioid consumption, presenting it as an effective non-opioid analgesic option.
XG005 is a novel, non-opioid chemical entity designed to target both nociceptive and neuropathic pain through a dual mode of action. In this trial, patients received either 750 mg or 1250 mg doses of XG005, or a placebo, twice a day for 72 hours. The study, conducted in collaboration with Evolution Research Group and Lotus Clinical Research at multiple U.S. sites, enrolled 450 patients, randomly assigned in a 1:1:1 ratio. Results indicated that XG005 was well tolerated, with an acceptable safety profile, and no serious adverse events related to the drug were observed.
Key Efficacy Results
The primary and key secondary efficacy endpoints, assessed through the Subjective Pain Intensity (SPI) over 48 hours, showed statistically significant improvements in both the 750 mg and 1250 mg XG005 groups compared to placebo. The 1250 mg dose provided more effective pain relief, demonstrating a dose-dependent response in this analgesic treatment.
Additional efficacy findings include:
- Pain Intensity Scores: Both active treatment groups showed a significant reduction in pain intensity compared to the placebo over 72 hours post-surgery (P<0.0001). The maximum pain in the high-dose group was classified as mild (<4.0 NRS), whereas the placebo group experienced pain levels as severe as >7.0 NRS during the same period.
- Time to First Rescue Medication: The high-dose group experienced a delay of up to 8-fold in the time to first use of rescue medication compared to the placebo group. The median times to first rescue medication were 31.47 hours for the high-dose group, 12.24 hours for the low-dose group, and 4.03 hours for the placebo (P<0.0001), showing that XG005 effectively sustained pain relief.
- Opioid Consumption: Total opioid consumption was significantly lower in both active treatment arms than in the placebo group (P<0.0001). The Morphine Equivalent Dose (MEQ) for the high-dose, low-dose, and placebo groups were 6.72, 9.38, and 23.86/24.68 mg, respectively, highlighting the analgesic effect of XG005 in reducing opioid use.
- Acetaminophen Use: Patients in the active treatment arms also required significantly less acetaminophen compared to placebo (P<0.0001). The mean acetaminophen use over 72 hours was 1586.03 mg for the high-dose group, 1975.89 mg for the low-dose group, and 4812.7 mg for the placebo group.
- Patient Global Assessment (PGA): The PGA for pain control was significantly higher in both XG005 treatment arms compared to placebo (P<0.0001), indicating better pain management in the active treatment groups.
- Sleep Quality: Sleep interference was significantly lower in the XG005-treated arms compared to the placebo, with the active treatment groups showing significantly better sleep quality (P<0.0001).
Dr. Leon Jiang, Chief Medical Officer at Xgene Pharmaceutical, commented, “I have not seen any analgesic treatments showing such impressive efficacy in well-controlled, multi-center trials. The high-dose group demonstrated mild pain severity, while the placebo group experienced severe pain. The reduction in opioid consumption and the lower use of rescue medications is striking, and this efficacy differentiates XG005 from other analgesics. We are encouraged by these results and are excited to expedite the development of this treatment for patients.”
Gene Hsu, CEO of Xgene Pharmaceutical, added, “There is a substantial need for more effective, safer, non-opioid treatments for acute pain. The results from this trial highlight the excellent therapeutic potential of XG005, which has the potential to offer a better treatment alternative compared to current analgesics.”
About Acute Pain
Acute pain, defined as pain lasting less than three months, affects millions of people globally. The acute pain market, valued at $50.03 billion in 2023, is projected to grow to approximately $78.36 billion by 2032. Despite this, there is a considerable unmet need for non-opioid analgesic treatments that can provide effective pain relief while minimizing side effects.
About XG005
XG005 is a novel molecule targeting two distinct pain pathways: anti-nociceptive and anti-neuropathic. As a potentially first-in-class oral analgesic, XG005 is under parallel development for both acute and chronic pain conditions. Due to its dual mechanism of action, XG005 offers enhanced inhibition of pain signal transmission, leading to better analgesic outcomes while maintaining a favorable safety profile.
XG005 has also shown positive Phase 2b results for chronic osteoarthritis pain, and a Phase 2 trial for cancer-induced bone pain is ongoing in Taiwan and Mainland China.
About Xgene Pharmaceutical
Xgene Pharmaceutical is committed to transforming medicine by developing innovative therapies that significantly improve patients’ lives. Focusing on pain and CNS conditions, Xgene leverages cutting-edge science and technology to address unmet medical needs. The company collaborates with healthcare providers, governments, and communities to deliver reliable, affordable treatments worldwide.
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