Phase III
The SAB, composed of international experts in the field of allergy immunotherapy, acknowledged the clinical benefits of gp-ASIT+™ and confirmed the interest of a follow-up study to enhance the future market positioning and differentiation of the compound.
Eisai Co., Ltd. announced that in the 8th meeting of the Data Safety Monitoring Board for the global Phase III clinical studies on the investigational oral BACE inhibitor elenbecestat in early Alzheimer’s disease, the DSMB reviewed safety data including the potential for decline in cognition, and recommended the continuation of the studies.
Gilead Sciences and Belgium-based Galapagos NV reported positive late-stage results from its FINCH 1 and FINCH 3 rheumatoid arthritis studies.
Proteon Therapeutics, based in Waltham, Mass., announced that its PATENCY-2 Phase III clinical trial of vonapanitase in chronic kidney disease (CKD) failed to meet its co-primary endpoints.
The South San Francisco cuts are not surprising, given that in December the company was forced to halt a Phase III study of Rova-T.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
BioSpace takes a quick look at some of the news coming from biotech and pharma companies from across Europe and Asia.
Aldeyra Therapeutics, headquartered in Lexington, Mass., announced positive results from its Phase III ALLEVIATE trial of reproxalap for allergic conjunctivitis.
Brisbane, Calif.-based Aimmune Therapeutics announced that its Phase III European clinical trial of AR101 for treatment of peanut allergy met its primary efficacy endpoint.
The debacle raised three broad questions: What will Biogen do next? Is the amyloid theory of Alzheimer’s now dead? And what else is going on in the Alzheimer’s drug development arena?
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