Novo Nordisk's liraglutide has shown promising results in a Phase III trial for pediatric obesity, while several oncology trials have faced setbacks. The liraglutide trial demonstrated a significant reduction in body mass index (BMI) in children aged 6 to 11, offering a potential new treatment option for this growing population. Meanwhile, terminations of Phase I trials by Pfizer and Les Laboratoires Servier have impacted the development of cancer therapies.
Liraglutide Demonstrates Efficacy in Pediatric Obesity
A Phase III trial (NCT04775082) of Novo Nordisk's liraglutide, a glucagon-like peptide-1 (GLP-1) analogue, has achieved its primary endpoint of change in BMI in pediatric patients aged 6 to 11 years. The study, published in the New England Journal of Medicine, revealed that after 56 weeks, the mean BMI change from baseline was -5.8% in the liraglutide group compared to +1.6% in the placebo group, a significant difference of -7.4%. Furthermore, 46% of treated patients experienced a BMI reduction of at least 5%, compared to only 9% in the placebo group. The rates of adverse events were similar between the two groups. This success led to a 13-point increase in the drug's Likelihood of Approval (LoA), bringing it to 50% for obesity.
Liraglutide, marketed as Saxenda for obesity and Victoza for type 2 diabetes, works by ensuring insulin release in response to high glucose levels and suppressing appetite. Novo Nordisk is also investigating its potential in Alzheimer's and Parkinson's diseases in Phase II trials.
Vaxcyte's Pneumonia Vaccine Shows Positive Results
Vaxcyte's VAX-31, a vaccine targeting streptococcal pneumonia, has shown positive topline data from a Phase I/II trial (NCT06151288). The trial evaluated the safety, tolerability, and immunogenicity of a single injection of VAX-31 compared to Pfizer’s Prevnar 20 (PVC20) in healthy adults. Results demonstrated robust opsonophagocytic activity (OPA) immune responses for all 31 serotypes at all studied doses. This positive outcome led to a 16-point increase in VAX-31's Phase Transition Success Rate (PTSR) in streptococcal pneumonia, reaching 54%.
VAX-31 is designed to prevent invasive pneumococcal disease (IPD) by stimulating a humoral and cellular immune response. IPD is particularly dangerous in infants, young children, older adults, and immunocompromised individuals.
Pfizer Terminates Maplirpacept Oncology Trial
Pfizer's maplirpacept, an immune checkpoint inhibitor, experienced a setback with the termination of a Phase I trial (NCT03530683). Consequently, the drug's PTSR decreased by 32 points to 35% in peripheral T cell lymphoma (PTCL) and by 14 points to 54% in B cell Hodgkin lymphoma. The trial termination was a business decision by Pfizer, unrelated to safety concerns or regulatory requests. Maplirpacept targets CD47-mediated immune suppression and aims to promote anti-tumor responses across various cancer settings.
Les Laboratoires Servier Discontinues Oncology Drug Trial
Les Laboratoires Servier's Phase I trial of S-64315 (MIK-665) and S-65487 (VOB-560) was terminated due to business reasons, impacting their PTSR in non-Hodgkin lymphoma (NHL), acute myeloid leukemia (AML), and multiple myeloma (MM). S-64315's PTSR decreased by 25 points to 31% in relapsed/refractory AML and by 36 points to 32% in NHL. S-65487's PTSR decreased by nine points in four indications, reaching 56% in MM, 55% in NHL, 54% in relapsed AML, and 52% in refractory AML. S-65487 and S-64315 are selective inhibitors of BCL2 and MCL1 proteins, respectively, both of which are often overexpressed in tumor cells, protecting them from cell death.
