Latigo Biotherapeutics Begins Phase 1 Trial of LTG-305 for Non-Opioid Pain Treatment

Latigo Biotherapeutics, Inc., based in Thousand Oaks, California, has initiated a Phase 1 clinical trial for its non-opioid drug candidate, LTG-305, aimed at treating chronic pain. This first-in-human trial has begun with the dosing of the first participant. The study, referenced as NCT06554574, will focus on evaluating the safety, tolerability, and pharmacokinetics of LTG-305 in healthy volunteers through cohorts of single-ascending doses (SAD) and multiple-ascending doses (MAD).

LTG-305 represents a novel approach as a Nav1.8 inhibitor, which targets the root mechanisms of pain transmission. Nav1.8 is a voltage-gated sodium channel integral to the propagation of pain signals in the body. By selectively inhibiting this channel, LTG-305 aims to provide effective pain relief while minimizing the central nervous system side effects often associated with current pain treatments, such as addiction, dizziness, and somnolence. This innovative small molecule offers a safer and more focused alternative for managing chronic pain.

Dr. Neil Singla, the chief medical officer of Latigo Biotherapeutics, highlighted the significance of this milestone, noting that LTG-305 adds another promising candidate to their portfolio of non-opioid pain medications. The company has previously reported positive results from a Phase 1 trial of LTG-001 for acute pain, reinforcing their confidence in the potential of Nav1.8 inhibitors for both acute and chronic pain management.

The Phase 1 trial will involve healthy participants administered with various dose levels of LTG-305. The primary goal is to assess the drug's safety and tolerability. The single-ascending dose (SAD) phase will involve participants receiving single doses at increasing levels to evaluate these parameters. Following this, the multiple-ascending dose (MAD) phase will have participants taking multiple doses over a set period. Latigo Biotherapeutics anticipates releasing topline results from this study by mid-2025.

Chronic pain is a widespread issue in the United States, affecting approximately 57 million individuals due to conditions including diabetic neuropathy, osteoarthritis, migraines, and lower back pain. The prevalent treatments involve opioids and gabapentinoids, leading to about 150 million prescriptions annually, with opioids making up half of these prescriptions. Current therapies often fail to provide adequate pain relief and are associated with severe side effects such as dizziness and somnolence. Additionally, a significant portion of those who misuse illicit opioids or heroin originally began with prescription opioids, highlighting the urgent need for safer, more effective pain management options.

Latigo Biotherapeutics is a clinical-stage biotechnology company focused on developing cutting-edge non-opioid pain medications that directly address the sources of pain. The company aims to deliver effective and fast-acting pain relief without the risks of addiction common with opioid treatments. Latigo is backed by notable investors like Westlake Village BioPartners, 5AM Ventures, Foresite Capital, and Corner Ventures.

This new development in the clinical trial of LTG-305 marks a significant step forward in the quest for safer chronic pain treatments, potentially offering millions of patients better options beyond traditional opioid therapies.