Zelos to Begin U.S., EU Osteoporosis Study
Zelos Therapeutics has reached agreements with the FDA and the European Medicines Agency (EMEA) for a Phase III registration study of ZT-031 in treating severe osteoporosis.
The drug, a parathyroid hormone analog, will be evaluated against alendronate (Fosamax) in an active comparator osteoporosis registration study. It will last 24 months and is expected to enroll 3,255 postmenopausal women with severe osteoporosis.
The study is part of a special clinical protocol assessment process with the FDA and a formal scientific advice meeting with the EMEA’s Committee for Human Medicinal Products. If successful, the trial would form the basis for an efficacy claim to market the drug in the U.S. and EU, Zelos said.