Itolizumab Shows Promising Results in Phase 2 Ulcerative Colitis Trial, Matching Adalimumab Efficacy
• Itolizumab demonstrated a 23.3% clinical remission rate in moderate to severe ulcerative colitis patients after 12 weeks, comparable to adalimumab's 20.0% and superior to placebo's 10.0%.
• The novel CD6-ALCAM pathway targeting drug achieved 16.7% endoscopic remission, matching adalimumab's performance while maintaining a favorable safety profile.
• The Phase 2 trial involved 90 biologic-naïve patients, with itolizumab showing efficacy despite having more severe cases in its treatment arm compared to control groups.
China NMPA Approves Astellas' Zolbetuximab for Advanced Gastric and GEJ Adenocarcinoma
• China's NMPA has approved zolbetuximab (VYLOY™) for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
• Zolbetuximab is the first monoclonal antibody approved in China that targets the CLDN18.2 biomarker expressed in gastric tumor cells.
• Approval was based on Phase 3 GLOW and SPOTLIGHT trials, showing statistically significant improvements in progression-free and overall survival.
• Approximately 35% of Chinese patients with advanced gastric and GEJ cancers have tumors expressing the CLDN18.2 biomarker.
Xenon's Azetukalner Shows Sustained Efficacy and Safety in Long-Term Focal Onset Seizure Study
• Xenon Pharmaceuticals' azetukalner demonstrates sustained reduction in seizure frequency and impressive seizure freedom rates in patients with focal onset seizures.
• Approximately one-third of patients treated with azetukalner for at least 36 months achieved seizure freedom for a year or longer, showcasing long-term efficacy.
• The X-TOLE open-label extension study highlights a consistent safety profile, suggesting azetukalner is generally well-tolerated over extended periods.
• Pre-clinical data indicates that Nav1.1 potentiators may offer protection against spontaneous seizures and SUDEP in a Dravet syndrome model.
Syndax's Revumenib Meets Primary Endpoint in AML Trial Despite Stock Drop
• Syndax Pharmaceuticals' Phase II trial of revumenib met its primary endpoint in patients with relapsed or refractory acute myeloid leukemia (AML).
• The AUGMENT-101 trial demonstrated a 23% complete remission rate in efficacy-evaluable patients with mutant NPM1 AML.
• Despite positive results, Syndax's stock experienced a significant drop, indicating investor concerns about the topline data.
• Revumenib targets the menin-MLL interaction and is positioned to potentially gain market share in the AML treatment landscape.
Parkinson's Disease Research Focuses on Disease-Modifying Therapies
• The Parkinson's disease (PD) therapeutic market faces unmet needs, notably the absence of neuroprotective/disease-modifying therapies (DMTs) and treatments for non-motor symptoms.
• A significant portion of the PD drug development pipeline is dedicated to neuroprotective and disease-modifying agents, targeting mechanisms like alpha-synuclein aggregation and neuroinflammation.
• Clinical trials are underway for therapies addressing postural instability, PD-dementia, and cognitive/emotional impairments, reflecting a comprehensive approach to managing PD's complexities.
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