Latigo Biotherapeutics, Inc. (Latigo), a clinical-stage biopharmaceutical company developing innovative non-opioid pain medicines, today announced the publication of positive results from the abdominoplasty clinical trial evaluating LTG-001 for the treatment of moderate-to-severe acute postoperative pain as an original research article in the New England Journal of Medicine (NEJM).

LTG-001 is an investigational selective Nav1.8 inhibitor, part of a new class of non-opioid analgesics designed to selectively block the transmission of pain. The publication reports results from a large-scale, double-blind, randomized, placebo- and comparator-controlled dose-ranging clinical trial evaluating LTG-001 versus placebo in adults with moderate-to-severe pain following abdominoplasty, a well-established postoperative pain model. The trial enrolled 343 participants who reported moderate or severe pain after surgery. The patients were randomized 1:1:1:1 to receive high-dose LTG-001 (450 mg loading dose followed by 300 mg every 12 hours), low-dose LTG-001 (300 mg loading dose followed by 150 mg every 12 hours), the opioid comparator, HB/APAP (commonly known as Vicodin; 5 mg hydrocodone bitartrate and 325 mg acetaminophen every 6 hours), or placebo. The study met its primary endpoint of the Summed Pain Intensity Difference over 48 hours (SPID48) versus placebo with high statistical significance and demonstrated rapid, clinically meaningful pain relief, favorable tolerability and opioid-sparing potential.

“This publication in the New England Journal of Medicine is a significant milestone for LTG-001,” said Neil Singla, M.D., chief medical officer of Latigo. “The publication of these findings adds to the growing scientific understanding of non-opioid approaches to pain management and comes at a time when there is broad recognition of the need for additional treatment options in the context of the ongoing opioid crisis.”

“From a clinical perspective, the published LTG-001 results in moderate-to-severe pain following abdominoplasty represent an important development in the treatment of acute pain, with the highest analgesic effect reported in a published industry-sponsored abdominoplasty trial,” said Harold Minkowitz, M.D, of ERG Research, an anesthesiologist and leading investigator who has been involved in more than 300 clinical trials in pain. “While opioids have historically been among the most effective options for treating acute pain, their associated risks underscore the importance of continued research into non-opioid approaches. These published results of LTG-001 add to the growing body of evidence supporting the investigation of novel, non-opioid mechanisms for pain management at a time when there remains significant focus on addressing the public health impact of opioid use.”

Key findings reported in NEJM from the abdominoplasty trial include:

  • Primary endpoint achieved, with high-dose LTG-001 achieving statistically significant improvement in Summed Pain Intensity Difference over 48 hours (SPID48) versus placebo

  • Patients receiving high-dose LTG-001 achieved a SPID48 of 62.1, representing the highest analgesic effect reported for any analgesic tested in the abdominoplasty pain model to our knowledge

  • High-dose LTG-001 showed an approximately 50% greater analgesic effect than Vicodin, the opioid comparator in the trial

  • Median onset of meaningful pain relief was approximately 52 minutes for high-dose LTG-001 and 83 minutes for the opioid comparator in the trial

  • 52.3% of patients receiving high-dose LTG-001 remained opioid-free throughout the 48-hour treatment period. In the placebo group, only 22.1% remained opioid-free

  • Dose response observed with low-dose LTG-001 (300 mg loading followed by 150 mg every 12 hours) also demonstrated statistically significant improvement versus placebo (SPID48 of 37.8) roughly comparable to the effect of the opioid comparator in the trial

  • Treatment-emergent adverse events were mostly mild to moderate, and overall adverse event levels were below those observed in the placebo arm

“The publication of the LTG-001 results in The New England Journal of Medicine recognizes the significance of these findings and marks an important milestone for Latigo,” said Nima Farzan, chief executive officer of Latigo. “We are honored to have these data published in such a prestigious journal, reflecting the quality of the science and the dedication of the patients, investigators, and Latigo team who made this achievement possible.”

About Latigo Biotherapeutics

Latigo Biotherapeutics is a private clinical-stage biopharmaceutical company committed to developing innovative non-opioid pain medicines designed to stop the transmission of pain without the risk of addiction, with the goal to provide effective, rapid-acting pain relief. Latigo is supported by leading investors, including Westlake Village BioPartners, Foresite Capital, 5AM Ventures, and Blue Owl Capital. Latigo’s lead program is LTG-001, an oral, selective Nav1.8 inhibitor in development to treat acute pain. For more information, please visit www.latigobio.com or follow us on LinkedIn.

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