IG-1119

As part of a Friday filing announcing its intent to raise fresh capital by going public, Latigo Biotherapeutics shared results from a Phase II trial evaluating lead programme LTG-001 in patients undergoing abdominoplasty, both of which will support an eventual submission for the Nav1.8 inhibitor in acute pain.The mid-stage study recruited 343 patients to receive one of two dosing regimens of LTG-001, placebo or the opioid comparator, Vicodin. The highest level of the experimental, non-opioid pain candidate comprised a 450-mg loading dose followed by 300 mg given every 12 hours, while the low-dose option used a 300-mg loading dose followed by 150 mg every 12 hours. Latigo reported that high-dose LTG-001 met its primary endpoint, achieving a roughly 50% greater analgesic effect than Vicodin as measured by Summed Pain Intensity Difference from 0 to 48 hours (SPID48). Patients taking LTG-001 saw a 62.1-point improvement on SPID48 versus placebo, while the opioid group reported a 40.9-point improvement. Low-dose LTG-001 led to a 37.8-point improvement. The biotech's oral pain treatment also succeeded on several key secondary measures, with the high dose enabling patients to achieve a  ≥2-point reduction in Numeric Pain Rating Scale (NPRS) score at 52 minutes compared with 83 minutes for Vicodin, suggesting a "rapid onset of meaningful pain relief." In addition, the high-dose non-opioid therapy helped 53% of patients remain opioid-free during the 48-hour treatment period; their pain was "sufficiently managed" by LTG-001 with no need for rescue medicine. According to Latigo, the FDA said the abdominoplasty study can serve as one of two pivotal trials required to support approval of LTG-001 for moderate-to-severe acute pain, including postoperative pain. For the second, the biotech will launch a Phase III trial in patients undergoing bunionectomy this half, with top-line results due in the second half of 2027. Following the same time schedule, Latigo is also planning to run an open-label Phase III safety trial evaluating LTG-001 across various post-surgical and non-surgical settings. Development of an intravenous formulation is also underway. Like Vertex Pharmaceuticals' Nav1.8 inhibitor Journavx (suzetrigine), Latigo said there are no data to suggest a potential for abuse or dependence associated with LTG-001 (see – Spotlight On: NaV-igating the next non-opioid agents for pain).While Journavx last year became the first non-opioid pain treatment greenlit by the FDA in more than two decades, the programme has struggled to take off in acute pain — and stumbled in chronic pain (see – Spotlight On: Despite setbacks, Vertex keeps its eyes on the chronic pain prize). Pain pipelineProceeds from Latigo's planned IPO will carry LTG-001 through to a US marketing submission and help the drugmaker prepare for its potential commercialisation. The funds will also go towards mid- and late-stage development of a separate, structurally distinct Nav1.8 inhibitor, LTG-321, for chronic musculoskeletal pain. The second programme recently finished a Phase I multiple ascending dose study in healthy volunteers and is now being assessed in a Phase II proof-of-concept trial that will enrol about 120 patients with osteoarthritis of the knee. Topline data are due in the second half of 2027, after which the IPO cash will help LTG-321 move into Phase III testing. Latigo also has a next-generation Nav1.8 inhibitor in the works. LTG-418 is structurally distinct from both LTG-001 and LTG-321 and could be dosed at "substantially lower" levels than the two preceding candidates. The biotech thinks it could be formulated to accommodate several modes of administration, including gels, patches, eye drops, inhalers and injectables.IPO onslaughtLatigo is gearing up to go public less than three years after launching with $135 million in series A funding. It then clinched a $150-million B round in 2025, on the heels of Journavx's approval in acute pain. The biotech is joining a wave of IPO activity, making it the seventh firm this month alone to lay plans for a public debut. The queue now includes BlossomHill Therapeutics, Vogenx, Attovia, Braveheart Bio, Scribe Therapeutics and Apnimed.For related analysis on how 2026 IPOs stack up to years past, see Spotlight On: Investors regain appetite for biotech IPOs.