Latigo Biotherapeutics publishes positive LTG-001 NEJM results
Latigo Biotherapeutics has published positive Phase II/III-like data for LTG-001 in the New England Journal of Medicine. The trial demonstrated that high-dose LTG-001 provided superior pain relief (SPID48 of 62.1) and faster onset (52 minutes) compared to Vicodin, while keeping 52.3% of patients opioid-free. This rare publication underscores the drug's potential as a leading non-opioid alternative for acute postoperative pain.
*this image is generated using AI for illustrative purposes only.
Latigo Biotherapeutics, Inc. announced today the publication of positive clinical trial results for its investigational non-opioid analgesic LTG-001 in the New England Journal of Medicine (NEJM). The data, derived from a large-scale abdominoplasty trial, demonstrate statistically significant pain reduction, rapid onset of action, and strong opioid-sparing potential. This publication represents a significant milestone for the clinical-stage biopharmaceutical company, marking only the second original research article in the NEJM reporting clinical results for a novel acute pain drug in the last 15 years.
The double-blind, randomized, placebo- and comparator-controlled dose-ranging trial enrolled 343 adults with moderate-to-severe postoperative pain following abdominoplasty. Participants were randomized in a 1:1:1:1 ratio 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 (Vicodin; 5 mg hydrocodone bitartrate and 325 mg acetaminophen every 6 hours), or placebo. The study met its primary endpoint of Summed Pain Intensity Difference over 48 hours (SPID48) versus placebo with high statistical significance.
Key Clinical Findings
The published results highlight the efficacy of LTG-001 as a selective Nav1.8 inhibitor. 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 date. This result was approximately 50% greater than the effect observed with Vicodin. Low-dose LTG-001 also demonstrated statistically significant improvement versus placebo with a SPID48 of 37.8, roughly comparable to the opioid comparator.
| Metric | High-Dose LTG-001 | Opioid Comparator (Vicodin) | Placebo |
|---|---|---|---|
| SPID48 Score | 62.1 | Not specified | Not specified |
| Median Onset of Relief | 52 minutes | 83 minutes | Not specified |
| Opioid-Free Patients (48h) | 52.3% | Not specified | 22.1% |
Patients receiving high-dose LTG-001 experienced a median onset of meaningful pain relief of approximately 52 minutes, compared to 83 minutes for the opioid comparator. Furthermore, 52.3% of patients in the high-dose LTG-001 group remained opioid-free throughout the 48-hour treatment period, compared to only 22.1% in the placebo group. Treatment-emergent adverse events were mostly mild to moderate, with overall adverse event levels below those observed in the placebo arm.
What the Numbers Show
The data indicates a clear dose-response relationship and superior efficacy compared to standard opioid therapy. The ability of high-dose LTG-001 to keep over half of patients opioid-free suggests a meaningful shift in postoperative pain management strategies. Neil Singla, M.D., chief medical officer of Latigo, stated that the findings add to the growing scientific understanding of non-opioid approaches amid the ongoing opioid crisis. Harold Minkowitz, M.D., of ERG Research, noted that the results represent an important development in acute pain treatment, highlighting the need for novel mechanisms given the risks associated with opioids.
Nima Farzan, chief executive officer of Latigo, emphasized that the publication reflects the quality of the science and the dedication of the team. Latigo Biotherapeutics is supported by investors including Westlake Village BioPartners, Foresite Capital, 5AM Ventures, and Blue Owl Capital.
What is the current timeline for Latigo Biotherapeutics to submit an NDA to the FDA based on these Phase 3 results?
How might the publication in NEJM influence payer reimbursement strategies for LTG-001 compared to existing opioid therapies?
Are there planned clinical trials to evaluate LTG-001's efficacy in other types of acute pain beyond post-abdominoplasty settings?
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