Researchers from Latigo Biotherapeutics and its clinical partners have reported positive Phase IIb data for its lead pipeline candidate, the non-opioid acute pain treatment LTG-001, which showed significantly greater pain reduction scores than placebo over 48 hours in patients with moderate or severe pain after abdominoplasty.

LTG-001 achieved the primary endpoint of the Phase IIb LTG-001-010 trial (NCT07102459) with high statistical significance by achieving better-than-placebo scores in the time-weighted sum of the pain-intensity difference (SPID) over the 48-hour treatment period (SPID48), based on the 0-10 range of scores of the Numeric Pain Rating Scale, with higher SPID48 values indicating greater pain reduction.

“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,” Neil Singla, MD, Latigo’s chief medical officer, said in a statement.

LTG-001 is an oral, non-opioid, selective Na_v 1.8 inhibitor designed to deliver opioid-level analgesia. According to Latigo, LTG-001 has led to high levels of Na_v 1.8 target inhibition due to both its potency and degree of penetration into the peripheral nerve.

Among the 85 patients dosed with the low dose of LTG-001, the least-squares mean (LSM) was 161.05 (95% CI), while the 86 high-dose patients showed a LSM of 185.30, compared with 164.08 among 86 patients treated with hydrocodone bitartrate-acetaminophen, and just 123.22 among the study’s 86 placebo patients.

“High-dose LTG-001, but not low-dose LTG-001, was associated with significantly lower opioid consumption than placebo, as well as a significantly higher percentage of patients who did not receive opioid rescue medication, with more than half the patients in the high-dose group not receiving opioid rescue medication,” the researchers reported in “Phase 2b Trial of a Na_v 1.8 Inhibitor for Acute Pain,” a Latigo-funded study published Thursday in The New England Journal of Medicine.

Secondary endpoints for the study included the amount of opioid rescue medication consumed in morphine milligram equivalents (MME) and patients receiving no opioid rescue medication.

LTG-001 also showed positive results on the secondary measures: High-dose LTG-001 patients showed lower consumption of rescue opioids compared with placebo (—7.35 difference in MME; 95% CI, p=0.01), and a higher percentage of patients not receiving opioid rescue treatment (30 percentage point difference, 95% CI, P<0.001).

Median time to meaningful pain relief, defined as a reduction of 2 or more points in the Numeric Pain Rating Scale (NPRS) score from baseline, was 60.0 minutes with low-dose LTG-001 and 51.7 minutes with high-dose LTG-001—both better than the 82.8 minutes shown by hydrocodone bitartrate-acetaminophen and the 87.5 minutes shown by placebo.

“Further investigation is warranted to confirm these results, characterize the efficacy and safety profile of LTG-001 in additional models of acute pain, and compare the relative efficacy of LTG-001 with that of other Na_v 1.8 inhibitors,” the researchers added.

Going public

Latigo, which is based in Thousand Oaks, CA, declined comment on the study, since it is in a quiet period before going public through a planned initial public offering (IPO). The company has applied to list its common stock on The Nasdaq Global Select Market under the symbol “LTGO”.

On July 17, Latigo filed a Form S-1 registration statement with the U.S. Securities and Exchange Commission (SEC) disclosing plans to raise an undetermined amount of capital; the number of shares to be sold, and their IPO price, have yet to be set.

However, Latigo did say that an undetermined portion of proceeds from the IPO toward advancing the development of LTG-001 through Phase III bunionectomy and open-label safety topline results, toward the submission of a New Drug Application (NDA) with the FDA, as well as toward commercial readiness.

“We plan to initiate a placebo-controlled Phase III trial in participants undergoing bunionectomy and an open-label Phase III safety trial exploring LTG-001 within a broader population of patients with moderate to severe acute pain across a variety of post-surgical and non-surgical settings in the second half of 2026, with topline results expected in the second half of 2027,” Latigo disclosed.

Also in Latigo’s pipeline is LTG-321, a next-generation Na_v 1.8 inhibitor initially being developed as a treatment for chronic musculoskeletal pain, starting with osteoarthritis (OA). Latigo has launched a Phase II proof of concept trial for LTG-321 in patients with OA of the knee. The trial is designed as a randomized, double-blind, placebo controlled, within subject crossover study in approximately 120 patients with Western Ontario and McMaster Universities.

The schools’ Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain is the primary endpoint to establish clinical proof-of-concept for LTG-321 in chronic musculoskeletal pain and inform subsequent pivotal trial design. Latigo said it expects to report topline results in the second half of 2027.

A Phase I trial of LTG-321 has produced data that showed, as of May 15, 2026, that the candidate achieved robust pharmacodynamic activity as measured by an increased pain tolerance threshold, with continued activity at 24 hours after a single dose in the cold pressor test (CPT). Latigo says it has refined its CPT methodology into a quantifiable and repeatable clinical endpoint that has translated into clinical trial outcomes for its lead product candidate LTG-001.

In its registration statement, Latigo acknowledged the first-in-class non-opioid, non-addictive selective pain signal Nav 1.8 inhibitor that reached the market last year—Journavx^® (suzetrigine), a sodium channel blocker marketed by Vertex Pharmaceuticals and consisting of a 100mg loading dose and 50mg maintenance dose. Journavx is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.

During the first quarter of 2026, more than 350,000 prescriptions of Journavx were filled, generating $29 million in revenue—more than 22 times the $1.3 million recorded in Q1 2025, soon after the drug’s launch in early March of last year. For all of 2025, more than 550,000 prescriptions for Journavx were written, generating $59.6 million in revenue. Vertex is set to release second quarter results on August 3, after the close of financial markets.

Since the launch of Journavx, more than one million prescriptions have been filled for the drug across hospital and retail settings for a broad range of acute pain conditions, according to Vertex.

“Despite the availability of multiple therapies for pain management, a substantial proportion of patients continue to experience inadequate pain control,” Latigo stated in its IPO registration filing, adding that Journavx “represents a safer non-opioid alternative, but is limited by efficacy, slow onset and contraindications.”

Journavx’s label includes one contraindication: Concomitant use with strong CYP3A inhibitors.

‘Critical unmet need’

“These constraints prevent adequate pain relief and force clinicians to balance incomplete analgesia against dose-limiting AEs [adverse events], addiction and contraindications. Consequently, current pain management strategies are frequently multi-modal, requiring patients to receive multiple classes of medications to achieve acceptable pain management,” Latigo added.

Even with such approaches, Latigo asserted, outcomes remain suboptimal. The company cited the findings of a 2015 study showing that up to 54% of patients with OA reported inadequate pain relief (IPR) despite taking prescription pain medications.

“This highlights the critical unmet need for safer, more effective, non-addictive pain alternatives,” Latigo stated in its IPO filing.

A total 343 patients were randomized 1:1:1:1 to low dose LTG-001 (300 mg loading dose, then a maintenance dose of 150 mg every 12 hours); high dose LTG-001 (450 mg loading dose, 300 mg maintenance dose every 12 hours), and an opioid comparator, oral hydrocodone bitartrate-acetaminophen (HB/APAP, commonly known as Vicodin; 5 mg hydrocodone bitartrate and 325 mg acetaminophen), or oral placebo (every six hours).

The researchers acknowledged limitations that included:

• Evaluation of LTG-001 as monotherapy rather than the multimodal manner in which acute pain is managed in clinical practice: “The magnitude of effect within a combined pain-management approach is unknown.”
• Patients with chronic pain conditions and previous use of opioids were excluded, though the vast majority of abdominoplasties are carried out in women, a reality reflected in the trial population.

“Further research is needed to confirm a potential effect of sex on the size of the treatment effect with LTG-001,” the researchers wrote.

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