LTG-305 Advanced Drug Monograph

LTG-305 Report

Name: LTG-305 Name (English): LTG-305

Originator: Latigo Biotherapeutics Class: Non-opioid analgesics; Small molecules Mechanism of Action: Nav1.8 voltage-gated sodium channel inhibitor Indication: Chronic pain (investigational) Highest Development Phase: Phase I

Clinical Trials:

• NCT06554574: A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants. This study is evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of oral LTG-305 in healthy volunteers. It includes single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts, as well as an evaluation of pain tolerance using a cold pressor test in male participants. The trial began in October 2024, with topline results expected by mid-2025.

Recent Events:

• October 2024: First participant dosed in the Phase 1 clinical trial.
• August 2024: Preclinical trials in Pain in USA (PO) prior to August 2024.
• August 2024: Latigo Biotherapeutics plans a phase I safety and pharmacokinetics trial in healthy subjects in New Zealand (PO) (NCT06554574).
• March 2025: Latigo Biotherapeutics raised $150 million in a Series B funding round to advance the development of LTG-305 and other non-opioid pain management drugs.

Target: Nav1.8 voltage-gated sodium channel, which is crucial for the transmission of pain signals. By selectively inhibiting Nav1.8, LTG-305 aims to provide effective pain relief with minimal central nervous system side effects.

Rationale: There is a significant unmet need for non-opioid pain treatments due to the limitations and risks associated with current therapies, including opioids (addiction, dizziness, drowsiness). LTG-305 represents a novel small molecule approach that targets the underlying mechanisms of chronic pain at its source.

Company Information: Latigo Biotherapeutics is a private, clinical-stage biotechnology company focused on developing innovative non-opioid pain medicines.

Note: LTG-305 is currently investigational and not approved for use outside of clinical trials.