Latigo Biotherapeutics Doses First Participant in Phase 1 Clinical Trial of LTG-305 for Non-Opioid Treatment of Pain

Potential best-in-class non-opioid Nav1.8 inhibitor, LTG-305 aims to provide safer treatment for chronic pain by targeting underlying mechanisms of pain at its source

Trial will evaluate safety, tolerability, and pharmacokinetics of LTG-305 in healthy volunteers through single- and multiple-ascending dose cohorts

Company anticipates reporting topline results in mid-2025

THOUSAND OAKS, Calif., Oct. 16, 2024 /PRNewswire/ -- Latigo Biotherapeutics, Inc. ("Latigo") today announced that the first participant has been dosed in its Phase 1 clinical trial of LTG-305, a potential best-in-class non-opioid therapeutic candidate for the treatment of chronic pain. This Phase 1 trial (NCT06554574) is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of LTG-305 in healthy volunteers through single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts.

LTG-305 is a Nav1.8 inhibitor designed to target the underlying mechanisms of pain at its source. This novel small molecule offers a potential non-opioid therapeutic approach to managing chronic pain, providing patients a safer and more targeted treatment option. Nav1.8, a voltage-gated sodium channel, plays a crucial role in the transmission of pain signals. By selectively inhibiting Nav1.8, LTG-305 aims to provide effective pain relief while avoiding central nervous system side effects associated with existing therapies, such as addiction, dizziness and somnolence.

"This important milestone in the clinical development of LTG-305 adds another potential best-in-class Nav1.8 inhibitor to our portfolio of non-opioid pain medicines in our pipeline," said Neil Singla, M.D., chief medical officer of Latigo Biotherapeutics. "We recently announced positive Phase 1 results for our candidate, LTG-001, which we are developing in acute pain, and advancing LTG-305 into the clinic reflects our confidence in the potential of Nav1.8 inhibitors in treating acute and chronic pain."

The Phase 1 trial will assess LTG-305 in healthy participants across multiple dose levels, with the primary objective of evaluating safety and tolerability. Latigo anticipates topline results from this study in mid-2025.

In the SAD portion of the study, healthy volunteers will receive a single dose of LTG-305 at increasing dose levels to assess its safety, tolerability, and PK. Following the SAD, the MAD portion will involve participants receiving multiple doses of LTG-305 over a defined period.

About Chronic Pain
Chronic pain affects approximately 57 million people in the U.S. as a result of conditions such as diabetic neuropathy, osteoarthritis, migraine, and lower back pain. The current standard of care involves opioids and gabapentinoids contributing to 150 million prescriptions annually, of which half are opioids. Chronic pain patients often suffer from inadequate pain relief and experience debilitating side effects from existing therapies, including dizziness and somnolence. Moreover, 80% of individuals using illicit opioids or heroin initially started with prescription opioids, underscoring the critical need for safer, more effective pain management strategies.

About Latigo Biotherapeutics
Latigo Biotherapeutics is a private clinical-stage biotechnology company developing innovative non-opioid pain medicines with potential best-in-class profiles that directly target the source of pain. Latigo's goal is to provide effective, rapid-acting pain relief without the risk of addiction. Latigo is supported by leading investors, including Westlake Village BioPartners, 5AM Ventures, Foresite Capital, and Corner Ventures. For more information, please visit www.latigobio.com or follow us on LinkedIn.

SOURCE Latigo Biotherapeutics