NXT629
- Generic Name
- NXT629
Tempest Therapeutics Seeks Strategic Partner for Promising Liver Cancer Drug Amezalpat Amid Funding Challenges
• Tempest Therapeutics is actively seeking strategic partnerships to advance its liver cancer drug amezalpat to Phase III trials after positive Phase II results showed a six-month improvement in overall survival.
• The FDA has recognized amezalpat's potential by granting it fast track and orphan drug designations for hepatocellular carcinoma, positioning it as the first PPAR-alpha antagonist that could reach market approval.
• Despite having FDA clearance for a pivotal Phase III trial in combination with Roche's Tecentriq and Genentech's Avastin, Tempest faces significant funding challenges with a market cap of just $25.1 million and increasing annual losses.
Amezalpat Gains FDA Fast Track and Orphan Drug Designations for Hepatocellular Carcinoma
• Amezalpat, a PPARα antagonist, receives Fast Track Designation from the FDA, following its prior Orphan Drug Designation for hepatocellular carcinoma (HCC).
• Phase 1b/2 trial data showed a 6-month improvement in median overall survival when amezalpat was added to atezolizumab and bevacizumab for advanced HCC.
• The combination therapy also demonstrated a 30% objective response rate, compared to 13.3% with atezolizumab and bevacizumab alone.
• Tempest Therapeutics is preparing for a pivotal Phase 3 study of amezalpat in first-line HCC, supported by agreements with the FDA and EMA.
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