Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Zelos Therapeutics has signed agreements with the FDA and the European Medicines Agency for a Phase III registration study of ZT-031 for the treatment of severe osteoporosis.
Subscribe to our email newsletter
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.