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news.Bone Medical (Bone) has received a formal response from the FDA to its IND application filed for use of Capsitonin in the debilitating condition osteoarthritis. Capsitonin is Bone Medical’s oral formulation of the approved osteoporosis drug salmon calcitonin. Bone has already filed one IND submission to the FDA for its use in osteoporosis.
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Bone has filed an IND submission in September 2009 for a 180 patient, one month phase 2b dose-ranging study using Womac as the primary endpoint for pain. The feedback requests that Bone completes a normal one month animal toxicology study prior to commencement of the trial, and GMP manufacture of further batches with details submitted, as anticipated. The trial design remains as proposed.
The company said that Calcitonin has a safety record and in an oral form, is well tolerated, there is the possibility of providing a safe and effective product into a multi-billion dollar market.
Bone has also received clarification on its Capsitonin sCT programme for osteoporosis, where the FDA have accepted a 6 month dose-ranging study using CTX as the primary endpoint in osteoporotic women prior to phase 3. Bone has clarified the requirement for a 12 month BMD study for the Phase 3 programme. This is an advantage as Bone is following a 505(B)2 regulatory pathway.
Leif Jensen, chairman and co-CEO of Bone Medical, said: “Bone continues to make good progress with its regulatory programmes and is reaping the benefit of having safe formulations to administer proteins orally. This lessens the burden of cost on small companies so that it can progress its projects to market in a timely manner.”