Eli Lilly and Company’s mirikizumab demonstrated superior histologic response compared to placebo and Stelara (ustekinumab) in a Phase 3 study for moderately to severely active Crohn’s disease. The drug showed a significant improvement in mucosal healing and a favorable safety profile, potentially offering a new treatment option for patients struggling with this chronic inflammatory bowel disease.
AbbVie’s investigational drug tavapadon, a D1/D5 dopamine receptor partial agonist, demonstrated positive results in a Phase 3 trial for early Parkinson’s disease. The drug showed a statistically significant improvement in motor function and quality of life compared to placebo in patients with early Parkinson’s disease.
Sanofi’s experimental drug tolebrutinib has shown positive results in a Phase 3 study for non-relapsing secondary progressive multiple sclerosis (nrSPMS), demonstrating a delay in disability progression compared to placebo. While previous studies on relapsing forms of MS did not meet the primary endpoint, the latest findings suggest tolebrutinib’s potential as a treatment option for secondary progressive MS.
Fulcrum Therapeutics’ stock plunged after the Phase 3 REACH trial evaluating losmapimod for Facioscapulohumeral Muscular Dystrophy (FSHD) failed to meet its primary endpoint. The study’s results contradict the positive findings observed in the Phase 2 trial, leading Fulcrum to suspend the losmapimod program for FSHD.
Viridian Therapeutics announced positive topline data from their THRIVE Phase 3 clinical trial for VRDN-001 (veligrotug), a potential treatment for active thyroid eye disease (TED). The trial met all primary and secondary endpoints, demonstrating veligrotug’s effectiveness in reducing symptoms and improving patient outcomes.
Merck & Co Inc has discontinued two Phase 3 trials evaluating Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer and cutaneous squamous cell carcinoma. The decision was based on recommendations from independent Data Monitoring Committees, which found that Keytruda did not demonstrate a statistically significant improvement in survival or recurrence-free survival compared to placebo.
Incyte Corporation announced positive results from a Phase 3 trial evaluating Monjuvi (tafasitamab) for relapsed or refractory follicular lymphoma, potentially expanding its use beyond diffuse large B-cell lymphoma. The trial met primary and key secondary endpoints, indicating the drug’s efficacy and safety.
Pfizer and BioNTech’s combined mRNA vaccine for influenza and COVID-19 has shown mixed results in a Phase 3 trial. While it met one of its primary immunogenicity objectives, it demonstrated lower responses against the influenza B strain compared to a licensed flu vaccine. The companies are evaluating adjustments to improve the vaccine’s effectiveness.
Tempest Therapeutics has secured FDA approval to move forward with a Phase 3 clinical trial for its cancer drug amezalpat in combination with atezolizumab and bevacizumab for first-line hepatocellular carcinoma (HCC). The company is optimistic about the trial’s success based on positive results from the Phase 2 study.
A phase 3 clinical trial, APPLAUSE-IgAN, has shown promising results in patients with immunoglobulin A nephropathy (IgAN) treated with iptacopan. The study found that iptacopan significantly reduced proteinuria, a key indicator of kidney function, by 38.3% compared to placebo at 9 months. Iptacopan is an oral Factor B inhibitor of the alternative complement pathway that was recently approved by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria. The trial included over 500 patients with IgAN and evaluated the drug’s efficacy and safety over 24 months. The results suggest that iptacopan may be a valuable new treatment option for IgAN, a progressive kidney disease affecting up to 30% of patients with persistently high proteinuria. Iptacopan’s specific targeting of the alternative complement pathway represents a novel approach to treating IgAN, offering hope for improved outcomes and reduced disease progression.
