Following the special clinical protocol assessment process with the FDA and a formal scientific advice meeting with the Committee for Human Medicinal Products of the European Medicines Agency (EMEA), Zelos Therapeutics has received regulatory approval for the design, conduct and analysis of a pivotal Phase III clinical study.
The trial, if successful, would form the primary basis for an efficacy claim to support applications for marketing authorization of ZT-031 in the US and Europe.
The 24-month Phase III study is expected to enroll 3,255 post-menopausal women with severe osteoporosis. The primary efficacy endpoint is the incidence of new vertebral fractures in the ZT-031 study arm compared with the alendronate study arm.
In addition, the FDA and EMEA have agreed to an innovative weight-based dosing regimen in which different dose strengths of ZT-031 will be used in patients in different weight categories.
Zelos Therapeutics believes that the safety and efficacy profile of ZT-031 that has been demonstrated to date, coupled with the anticipated improvements in clinical benefit that may result from weight-based dosing, could position ZT-031 favorably against Forteo (teriparatide), the only bone formation therapeutic currently approved for use in the US.