Latigo Biotherapeutics has commenced its Phase 1 clinical trial of LTG-305, a novel non-opioid therapeutic candidate aimed at treating chronic pain. The first participant has been dosed in the study (NCT06554574), which will assess the safety, tolerability, and pharmacokinetics of LTG-305 in healthy volunteers through single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts. Topline results are expected in mid-2025.
LTG-305 is designed as a selective Nav1.8 inhibitor, targeting a voltage-gated sodium channel crucial in pain signal transmission. By inhibiting Nav1.8, LTG-305 aims to provide effective pain relief while minimizing the central nervous system side effects commonly associated with existing therapies, such as addiction, dizziness, and somnolence.
Targeting the Source of Chronic Pain
Chronic pain affects approximately 57 million people in the U.S., stemming from conditions like diabetic neuropathy, osteoarthritis, migraine, and lower back pain. Current treatments often involve opioids and gabapentinoids, resulting in 150 million prescriptions annually, half of which are for opioids. These treatments often provide inadequate relief and cause debilitating side effects. The fact that 80% of individuals using illicit opioids or heroin initially started with prescription opioids underscores the urgent need for safer, more effective pain management strategies.
Clinical Trial Design and Objectives
The Phase 1 trial will evaluate LTG-305 across multiple dose levels in healthy participants. The primary objective is to assess the drug's safety and tolerability. The SAD portion of the study involves administering single doses of LTG-305 at increasing levels to evaluate safety, tolerability, and pharmacokinetics. Following the SAD phase, the MAD portion will involve participants receiving multiple doses of LTG-305 over a defined period.
Company Perspective
"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."
