Clinical-stage biotechnology company Latigo Biotherapeutics announced on Monday that it has received Fast Track designation (FTD) from the US Food and Drug Administration (FDA) for LTG-001 for the treatment of acute pain.
LTG-001 is an oral, investigational selective inhibitor of Nav1.8, a key sodium channel involved in pain signalling. LTG-001 works by blocking peripheral sensory neurons responsible for pain signals, thus preventing the transmission of these pain signals to the central nervous system.
The FTD follows positive Phase 1 results which demonstrated a favourable safety, tolerability and pharmacokinetic profile for LTG-001.
Latigo CEO Nima Farzan said: "We are pleased the FDA has granted Fast Track designation to LTG-001, recognising its potential to transform the treatment landscape for acute pain by targeting pain at its source. This marks an important milestone for Latigo and reinforces the promise of LTG-001 as a highly selective, well-tolerated non-opioid approach for treating pain. With this designation, we look forward to working closely with the FDA to accelerate development and bring this much-needed non-opioid medicine to patients rapidly."
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval