Latigo Biotherapeutics Announces New England Journal of Medicine Publication of Positive LTG-001 Abdominoplasty Clinical Trial Results in Moderate-to-Severe Acute Pain
Results demonstrated statistically significant pain reduction, rapid onset of analgesia, and opioid-sparing potential of investigational selective Nav1.8 inhibitor LTG-001
Marks only the second original research publication in the New England Journal of Medicine reporting clinical results for a novel drug for acute pain in the last 15 years
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.
