Bone Medical receives US FDA guidance on osteoporosis drug
Recommendations provide clear path towards Phase III trial
Bone Medical has received a formal response from the US FDA to the IND application filed in June for Capsitonin™, its oral formulation of the approved osteoporosis drug salmon calcitonin.
In their response, the FDA has advised that Bone Medical now has an open IND and identifies pathway the Company can undertake including a 12-month Phase III study with a primary endpoint of change in bone mineral density, avoiding the need to focus on collecting bone fracture data in multi-year studies, as is required with new drugs for this chronic condition. The response also indicates a requirement for modest non-clinical data regarding pharmacokinetics and toxicology; this is as expected due to the nature of the oral formulation that specifically avoids any new chemical entities.
Prior to comme ncing the Phase III study Bone Medical intends to undertake further work on the scaling-up of the Capsitonin™ GMP manufacturing process and to generate further data identifying the appropriate dose levels to be used in the study.
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