FDA Fast Tracks Latigo's LTG-001 for Non-Opioid Acute Pain Treatment

Latigo Biotherapeutics, based in Thousand Oaks, California, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, LTG-001. This oral medication is a selective Nav1.8 inhibitor designed for the treatment of acute pain. It functions by blocking peripheral sensory neurons, effectively preventing pain signals from reaching the central nervous system. The Fast Track designation was awarded following positive results from a Phase 1 trial, which demonstrated that LTG-001 has a favorable safety and tolerability profile, as well as predictable pharmacokinetics.

Nima Farzan, the CEO of Latigo, expressed satisfaction with the FDA's decision to grant Fast Track designation, emphasizing the drug's potential to significantly impact the treatment of acute pain by directly addressing the source of pain. Farzan highlighted this milestone as an affirmation of LTG-001's promise as a non-opioid, selective, and well-tolerated pain treatment. The Fast Track designation is expected to facilitate a more streamlined development and regulatory review process, allowing Latigo to potentially bring this much-needed medication to patients more quickly.

Dr. Neil Singla, Latigo's Chief Medical Officer, stressed the importance of this designation in light of the substantial unmet medical need among patients experiencing acute pain. He emphasized the significant demand for effective non-opioid pain treatments and expressed enthusiasm for advancing LTG-001's clinical program.

The FDA's Fast Track designation is designed to accelerate the development and review of drugs that address serious or life-threatening conditions and fulfill unmet medical needs. This designation provides recipients with more frequent interactions with the FDA throughout the clinical development process. Additionally, if certain criteria are met, the FDA may review parts of a marketing application before the complete application is submitted.

The Phase 1 clinical trial for LTG-001 involved 72 healthy participants and aimed to assess the safety and tolerability of the drug in both single and multiple ascending oral doses. The study also evaluated the relative bioavailability and impact of food on LTG-001 compared to a placebo. The findings revealed that LTG-001 was well tolerated, with rapid absorption observed at approximately 1.5 hours post-administration. The pharmacokinetics were predictable, and the drug exposure was proportional across different dose levels. This rapid onset is promising for managing both acute and chronic pain, suggesting that LTG-001 could offer prompt relief.

Latigo Biotherapeutics is a private, clinical-stage biotechnology company that focuses on developing innovative, non-opioid medications for pain management. The company's mission is to offer effective and fast-acting pain relief without the risks associated with opioid treatments. Supported by prominent investors such as Westlake Village BioPartners, 5AM Ventures, Foresite Capital, and Corner Ventures, Latigo aims to revolutionize the approach to pain treatment by directly targeting the underlying sources of pain.