Latigo Biotherapeutics Publishes Positive Phase 2 LTG-001 Acute Pain Trial Results in The New England Journal of Medicine
Latigo Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing innovative non-opioid medicines for pain management, has announced the publication of positive clinical data for its investigational therapy LTG-001 in The New England Journal of Medicine (NEJM). The peer-reviewed publication highlights encouraging findings from a large Phase 2 clinical trial evaluating LTG-001 for the treatment of moderate-to-severe acute postoperative pain following abdominoplasty surgery. The results add to the growing body of scientific evidence supporting selective sodium channel inhibition as a promising strategy for delivering effective pain relief without relying on opioid medications.
The publication represents an important milestone for the company as healthcare providers continue to seek safer alternatives to opioids for managing acute pain. With opioid-related dependence and overdose remaining major public health concerns worldwide, the development of effective non-opioid therapies has become a significant priority across the medical community.
LTG-001: A Novel Non-Opioid Approach to Pain Management
LTG-001 is an investigational selective Nav1.8 inhibitor, belonging to a new generation of pain medicines designed to interrupt pain signaling before it reaches the brain. Unlike opioid medications, which act on opioid receptors throughout the central nervous system, LTG-001 selectively blocks the Nav1.8 sodium channel found primarily in peripheral pain-sensing neurons.
Nav1.8 plays a critical role in transmitting pain signals generated by tissue injury. By specifically targeting this pathway, LTG-001 is intended to reduce pain while avoiding many of the adverse effects commonly associated with opioids, including respiratory depression, sedation, dependence, and addiction.
Researchers believe this mechanism offers the possibility of providing strong analgesic effects while minimizing many of the safety concerns that have historically limited pain management options.
Large Randomized Clinical Trial Evaluated LTG-001
The findings published in NEJM are based on a rigorous Phase 2 clinical trial conducted using the abdominoplasty postoperative pain model, which is widely recognized as one of the most reliable and standardized methods for evaluating acute pain medications.
The study enrolled 343 adult participants who experienced moderate-to-severe pain following abdominoplasty surgery.
Participants were randomly assigned in equal proportions to one of four treatment groups:
- High-dose LTG-001
- Low-dose LTG-001
- Hydrocodone/acetaminophen (Vicodin) comparator
- Placebo
The study employed a double-blind, randomized, placebo-controlled and active-comparator-controlled design, ensuring that neither investigators nor participants knew which treatment was administered during the trial.
Treatment Regimens
Patients assigned to the high-dose LTG-001 group received:
- An initial 450 mg loading dose
- Followed by 300 mg every 12 hours
The low-dose treatment arm received:
- A 300 mg loading dose
- Followed by 150 mg every 12 hours
The active comparator consisted of hydrocodone bitartrate 5 mg combined with acetaminophen 325 mg (commonly marketed as Vicodin), administered every six hours.
The placebo group received matching placebo treatment throughout the evaluation period.
Researchers monitored pain relief over the first 48 hours following surgery while also evaluating medication safety, tolerability, rescue opioid use, and onset of analgesia.
Primary Endpoint Successfully Achieved
The study successfully met its primary endpoint by demonstrating a statistically significant improvement in Summed Pain Intensity Difference over 48 hours (SPID48) for patients receiving high-dose LTG-001 compared with placebo.
SPID48 is a well-established clinical measurement used in pain research that combines pain intensity scores collected over time into a single overall assessment of analgesic effectiveness.
According to the published results, patients treated with high-dose LTG-001 experienced substantial reductions in postoperative pain throughout the observation period.
Researchers reported that the difference versus placebo reached a high level of statistical significance, confirming the investigational therapy’s effectiveness.
Strong Analgesic Performance Observed
One of the most notable findings from the trial was the magnitude of pain relief achieved by high-dose LTG-001.
Patients receiving the higher dose achieved a SPID48 score of 62.1.
According to the investigators, this represents the highest analgesic effect reported to date in an industry-sponsored abdominoplasty pain study.
The data suggest that LTG-001 may provide exceptionally strong pain control within this commonly used postoperative pain model.
Outperformed the Opioid Comparator
Beyond outperforming placebo, LTG-001 also demonstrated superior efficacy compared with the opioid comparator used in the study.
Investigators reported that the analgesic benefit observed with high-dose LTG-001 was approximately 50 percent greater than that achieved with hydrocodone/acetaminophen.
This finding is particularly significant because opioid medications have long served as the standard treatment for moderate-to-severe postoperative pain.
Demonstrating greater pain reduction than an established opioid therapy highlights the potential of selective Nav1.8 inhibition as a meaningful alternative for acute pain management.
Rapid Onset of Pain Relief
Speed of pain relief is an important consideration for patients recovering from surgery.
The study showed that LTG-001 began providing meaningful analgesia relatively quickly.
Among patients receiving the high-dose regimen, the median time to meaningful pain relief was approximately 52 minutes.
By comparison, patients receiving the opioid comparator experienced meaningful pain relief after a median of approximately 83 minutes.
These findings suggest LTG-001 may offer not only greater overall pain reduction but also a faster onset of action than the opioid comparator included in the trial.
Reduced Need for Opioid Rescue Medication
An additional goal of modern pain management is minimizing opioid exposure whenever possible.
The study demonstrated encouraging opioid-sparing effects for LTG-001.
More than half (52.3%) of patients treated with high-dose LTG-001 completed the entire 48-hour treatment period without requiring any rescue opioid medication.
In contrast, only 22.1% of patients in the placebo group remained opioid-free throughout the study.
Reducing opioid use following surgery has the potential to decrease exposure to medications associated with dependence while maintaining effective pain control.
Lower Dose Also Demonstrated Clinical Benefit
The trial also evaluated a lower-dose LTG-001 regimen.
Patients receiving the lower dose achieved a SPID48 score of 37.8.
Although the analgesic effect was smaller than that observed with the higher dose, investigators reported statistically significant improvement compared with placebo.
The pain relief achieved with the lower dose was considered generally comparable to that observed with the opioid comparator, further supporting evidence of a dose-response relationship.
Favorable Safety and Tolerability Profile
Safety findings from the study were also encouraging.
Treatment-emergent adverse events associated with LTG-001 were primarily mild to moderate in severity.
Investigators further reported that the overall incidence of adverse events in patients receiving LTG-001 was actually lower than that observed in the placebo group.
No unexpected safety concerns emerged during the study, supporting continued clinical development of the investigational therapy.
The favorable tolerability profile is particularly important given the challenges associated with many currently available pain medications.
Medical Experts Highlight Clinical Importance
Dr. Neil Singla, Chief Medical Officer of Latigo Biotherapeutics, described publication in The New England Journal of Medicine as an important milestone for both LTG-001 and the broader field of non-opioid pain research.
He noted that publication in one of the world’s most respected medical journals reflects the growing scientific interest in developing effective alternatives to opioid therapy, particularly as healthcare systems continue addressing the long-term consequences of opioid misuse.
Dr. Harold Minkowitz of ERG Research, an anesthesiologist and experienced clinical investigator who has participated in more than 300 pain studies, also emphasized the importance of the findings.
According to Dr. Minkowitz, although opioids remain highly effective for treating acute pain, their well-recognized risks continue to drive the search for safer therapies. He noted that LTG-001 produced one of the strongest analgesic responses reported in the abdominoplasty pain model, further strengthening evidence supporting selective Nav1.8 inhibition as a promising therapeutic strategy.
Company Advances Non-Opioid Pain Innovation
Latigo Chief Executive Officer Nima Farzan stated that publication in NEJM represents recognition of both the scientific quality of the research and the collaborative efforts of patients, investigators, and the company’s development team.
He emphasized that the publication validates years of research dedicated to advancing innovative non-opioid medicines capable of delivering meaningful pain relief while potentially reducing reliance on opioid medications.
The company continues to advance LTG-001 through clinical development as part of its broader mission to transform pain management using novel, targeted therapies.
The publication of LTG-001 clinical data in The New England Journal of Medicine marks a significant achievement for Latigo Biotherapeutics and contributes important evidence supporting the future of non-opioid pain management. By demonstrating rapid, clinically meaningful pain relief, superior efficacy compared with a commonly prescribed opioid, favorable tolerability, and substantial opioid-sparing potential, LTG-001 has emerged as a promising investigational therapy for acute postoperative pain.
As the medical community continues seeking safer and more effective approaches to pain treatment, selective Nav1.8 inhibitors like LTG-001 may represent a new generation of analgesics capable of improving patient outcomes while reducing dependence on traditional opioid medications. Continued clinical evaluation will help determine the therapy’s potential role in addressing one of healthcare’s most pressing unmet needs.
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 Nav1.8inhibitor in development to treat acute pain. For more information, please visit www.latigobio.com or follow us on LinkedIn.