Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape
• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.
• Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development.
• Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
Pipeline for Pulmonary Arterial Hypertension Treatment Expands with 55+ Companies Developing Novel Therapies
• DelveInsight's latest report reveals over 55 companies actively developing 55+ pipeline drugs for Pulmonary Arterial Hypertension treatment, indicating robust research activity in this therapeutic area.
• Breakthrough therapies like Sotatercept by Acceleron Pharma and LIQ861 by Liquidia Technologies are advancing through clinical trials, offering new hope for PAH patients.
• Multiple clinical trials are underway in early 2025, including studies by Actelion, Keros Therapeutics, Insmed Incorporated, and Merck Sharp & Dohme, focusing on novel treatment approaches.
Liver Cirrhosis Clinical Trial Pipeline Gains Momentum
The liver cirrhosis treatment market is experiencing significant growth, driven by advancements in antiviral therapies and regenerative medicine. Over 30 companies are actively developing new treatments, with several promising therapies currently in clinical trials.
Hepatology Review: FDA Updates, Viral Hepatitis Research, and MASH Advancements in December 2024
• The FDA updated safety information for obeticholic acid (Ocaliva) regarding liver injury risk in primary biliary cholangitis (PBC) patients without cirrhosis.
• Breakthrough Therapy designation was granted to tobevibart and elebsiran by the FDA and EMA for chronic hepatitis delta (CHD) treatment, based on Phase 2 SOLSTICE trial data.
• Atea Pharmaceuticals reported positive Phase 2 results for bemnifosbuvir and ruzasvir in hepatitis C virus (HCV) treatment, achieving a 98% SVR12 rate.
• Belapectin, from Galectin Therapeutics, in MASH cirrhosis and portal hypertension, did not meet its primary endpoint in the Phase 2b/3 NAVIGATE trial.
Belapectin Shows Significant Reduction in New Varices in U.S. MASH Cirrhosis Patients
• Belapectin demonstrates a statistically significant 68.1% reduction in the incidence of new varices compared to placebo in U.S. patients with MASH cirrhosis and portal hypertension.
• The analysis comes from the NAVIGATE trial, focusing on per-protocol patients (completers) enrolled in the U.S., highlighting the drug's potential in this subgroup.
• An estimated 3 million adults in the U.S. suffer from MASH cirrhosis with clinically significant portal hypertension, an area with no FDA-approved therapies.
• Further analysis of the NAVIGATE trial, including data from patients completing 36 months of treatment, is expected by the end of Q1 2025.
Galectin Therapeutics' Belapectin Fails to Meet Primary Endpoint in MASH Cirrhosis Trial
• Galectin Therapeutics' NAVIGATE trial of belapectin in MASH cirrhosis patients with portal hypertension did not meet its primary endpoint of preventing varices.
• While belapectin reduced varices incidence in the intent-to-treat population, the difference was not statistically significant compared to placebo.
• In a per-protocol analysis, belapectin showed a 48.9% reduction in varices, but this fell short of the targeted 52.5%.
• The safety profile of belapectin remains encouraging, with adverse events comparable to placebo; further analysis and 36-month outcomes are pending.
NASH Treatment Market to Reach Significant Growth by 2032, Driven by Emerging Therapies
• The non-alcoholic steatohepatitis (NASH) market is poised for substantial growth, projected to expand significantly by 2032 across the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
• This growth is fueled by the introduction of novel therapies targeting NASH, with several drugs in Phase II and Phase III clinical trials showing promise for improving treatment outcomes.
• Key players such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, and Novo Nordisk are actively developing innovative treatments, contributing to a dynamic and competitive market landscape.
• The increasing prevalence of NASH and the growing understanding of its pathophysiology are driving the demand for effective therapies, creating opportunities for pharmaceutical companies.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
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