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(Incorporated in Delaware)
We are a clinical biopharmaceutical company developing non-opioid oral therapies for acute and chronic pain. We are ready for Phase 3.
We are committed to developing innovative non-opioid pain medicines designed to rapidly and effectively stop the transmission of pain without the risk of addiction. Pain represents one of the largest and most pervasive therapeutic markets in the United States, driving an estimated 250 million prescriptions annually across acute and chronic settings; however, a continued reliance on opioids has contributed to a persistent public health crisis with significant societal and economic costs.
Our two most advanced candidates, LTG-001 and LTG-321, are oral Nav1.8 inhibitors designed to inhibit the transmission of pain. We are also advancing additional Nav1.8 candidates that can address alternative formulation and delivery approaches.
Nav1.8 is a voltage-gated sodium channel that plays a significant role in transmission of pain, and the role of Nav1.8 as a pain target has been genetically and clinically validated. Since Nav1.8 is substantially expressed in peripheral nerve tissue and not in the brain or other tissue, its inhibition has not been associated with addiction or severe tolerability concerns.
LTG-001, our lead candidate, is an oral Nav1.8 Inhibitor for moderate to severe acute pain, including post-operative pain. LTG-001 is being developed as an oral twice daily treatment that is intended for use as needed for up to 30 days and as an IV therapy to enable transition from the post-operative period to patient discharge in hospital settings.
We plan to initiate a placebo-controlled Phase 3 trial in participants undergoing bunionectomy, and an open-label Phase 3 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.
We anticipate submitting a NDA seeking FDA approval of LTG-001 as a potential treatment for moderate to severe acute pain, including postoperative pain, in adults, pending successful outcomes in the Phase 3 bunionectomy trial, the Phase 3 safety trial and completion of our other planned NDA-and label-enabling studies.
LTG-321 is our next-generation candidate for the inhibition of Nav1.8, initially being developed for the treatment of chronic musculoskeletal pain, starting with osteoarthritis (OA). LTG-321 is structurally distinct from LTG-001. LTG-321’s differentiated profile may enable a lower effective dose and once-daily dosing, characteristics we believe are particularly important for a chronic-use setting. In the Phase 1 trial, data as of May 15, 2026 showed that LTG-321 demonstrated 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). We have refined the CPT methodology and it has provided a quantifiable and repeatable clinical endpoint that has translated into clinical trial outcomes for our lead product candidate.
We have initiated a Phase 2 proof-of-concept trial investigating LTG-321 in patients with OA of the knee. The trial is designed as a randomized, double-blind, placebo controlled within subject crossover trial in approximately 120 patients with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain as the primary endpoint to establish clinical proof-of-concept in chronic musculoskeletal pain and inform subsequent pivotal trial design. We expect to report topline results in the second half of 2027.
Our earlier stage pipeline consists of LTG-418, a next-generation Nav1.8 inhibitor being developed for the treatment of acute and chronic pain. LTG-418 is structurally distinct from LTG-001 and LTG-321 and is predicted to have a dose which will be substantially lower than the expected doses for LTG-001 and LTG-321. We believe the predicted lower dose with LTG-418 is one of the features that may enable additional opportunities for other formulations and routes of administration, including gels, patches, eye drops, inhalers and injectables, expanding our reach within the pain market and offering patients therapeutic options beyond oral and IV delivery.
Suitable tolerability was demonstrated in a completed 14-day non-GLP toxicology study and in the in-life portion of an ongoing 14-day non-GLP toxicology study in non-human primates (NHPs). We are also in discovery of additional ion channel modulators involved in peripheral transmission of pain that represent potential complementary mechanisms of action to Nav1.8 inhibition for additional pain relief, including in chronic pain etiologies like neuropathic pain.
Note: Net loss is for the 12 months that ended March 31, 2026. The company has not generated any product revenue.
(Note: Latigo Biotherapeutics disclosed the terms for its IPO on Aug. 3, 2026, in an S-1/A filing: 16 million shares at a price range of $16.00 to $18.00 to raise $272.0 million, if priced at the $17.00 mid-point of its range. Background: Latigo Biotherapeutics filed its S-1 for its IPO on July 17, 2026, without disclosing the terms. Estimated IPO proceeds were $100 million, a placeholder figure.)
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