TERN-501
- Generic Name
- TERN-501
NASH Pipeline Shows Promise with 80+ Emerging Therapies in Development
• Over 80 companies are actively developing treatments for Non-Alcoholic Steatohepatitis (NASH), with Inventiva Pharma and Cirius Therapeutics leading with Phase III candidates lanifibranor and MSDC-0602K respectively.
• Lanifibranor, a triple PPAR agonist with FDA Breakthrough Therapy designation, demonstrates significant anti-inflammatory and antifibrotic properties, while MSDC-0602K selectively modulates the mitochondrial pyruvate carrier to improve metabolic parameters.
• Novel therapeutic approaches include Terns Pharmaceuticals' THR-β agonist TERN-501 and HighTide Biopharma's HTD1801, both showing promising results in reducing liver fat and improving metabolic markers in Phase II trials.
Terns Pharmaceuticals Advances CML Drug TERN-701 and Obesity Treatment TERN-601 in Clinical Trials
• TERN-701, an oral BCR-ABL inhibitor for chronic myeloid leukemia, completes dose escalation phase with promising safety profile and molecular responses in heavily pre-treated patients.
• TERN-601, an oral GLP-1 receptor agonist for obesity, advances to Phase 2 FALCON trial with innovative titration strategy, targeting competitive weight loss outcomes.
• Drug interaction studies reveal TERN-701's favorable safety profile with common medications, marking a key differentiation in the allosteric TKI class.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
Madrigal's Resmetirom Nears Full Approval for NASH Cirrhosis Treatment Following Phase 3 Enrollment Completion
• Madrigal Pharmaceuticals completed patient enrollment for its MAESTRO-NASH OUTCOMES trial, evaluating resmetirom for compensated NASH cirrhosis.
• The Phase 3 trial involves 845 patients and aims to measure the progression to liver decompensation events over two to three years.
• Positive outcomes from the trial could support full approval of Rezdiffra for noncirrhotic NASH and expand its indication to cirrhotic patients.
• Resmetirom, a liver-directed THR-β agonist, has already received accelerated approval for NASH with moderate to advanced liver fibrosis.
Terns Pharmaceuticals' Oral GLP-1 Agonist TERN-601 Shows Promise in Phase 1 Obesity Trial
• Terns Pharmaceuticals announced positive Phase 1 results for TERN-601, an oral GLP-1R agonist, showing statistically significant weight loss of up to 5.5% over 28 days.
• The trial demonstrated a placebo-adjusted mean weight loss of 4.9% at the highest dose (740 mg), with 67% of participants losing 5% or more of their body weight.
• TERN-601 was well-tolerated, with no treatment-related dose interruptions, reductions, or discontinuations, indicating potential for improved tolerability in future studies.
• Terns plans to initiate a Phase 2 clinical trial in 2025 to further evaluate TERN-601 as a monotherapy or in combination with other agents for obesity treatment.
Drug Development Updates
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