Phase I

In the wake of Pfizer’s voluntary market withdrawal of the popular sickle cell disease therapy, BioSpace looks at five investigational drugs currently making their way through the pipeline.
With positive results for patients with the chronic skin condition, Jasper Therapeutics’ briquilimab is looking to take on Novartis and Genentech’s Xolair as well as Sanofi and Regeneron’s Dupixent.
Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects.
When doses were increased rapidly in a Phase I study, patients on Roche’s investigational oral GLP-1 receptor agonist experienced nausea, vomiting, constipation, diarrhea, as well as abdominal distension.
On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate.
Without revealing specific details, GSK announced that it is terminating the development of its investigational herpes simplex virus vaccine after failing to meet the study’s primary efficacy objective.
Phase I data for TERN-601 suggests Terns’ oral GLP-1 candidate for obesity could be a contender in the market next to big names like Lilly, Pfizer and Roche.
Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.
The highly anticipated results come as the company makes significant changes to its C-suite. Despite the turnover, Dyne said it is looking toward expedited approval pathways for its DMD treatment.
FDA
In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.
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