Bone Medical Limited announced that it has had discussions with FDA on the US regulatory process for CaPTHymone™, Bone’s oral Parathoid Hormone product.
Bone’s Chairman, Leif Helth Jensen said “We are very pleased with the outcome of our discussions as we have largely had our plans for product development and regulatory strategy for CaPTHymone™ confirmed.”
“Our next clinical step is to enter a Phase IIb study where the primary clinical end point will be lumbar spine Bone Mineral Density (BMD) and the secondary end point will be the bio maker P1NP. This study is likely to take 6 months and involved an estimated 150 patients.’
“Assuming this trial meets its clinical endpoint, the next step will be a pivotal Phase III non-inferiority study of 12 months duration, involving an estimated 400 patients, which will be sufficient for registration purposes under rule 505(b)(2).” continued Leif Helth Jensen.
The FDA also wants Bone to document that CaPTHymone™’s pharmacokinetics are similar to that of Forte’s (Lilly’s injectable PTH product), a benchmark Bone is comfortable it can meet.
Bone’s Chief Scientific Officer, Dr Roger New said “For the first time Bone now knows exactly what the FDA will need documented. Based on previous clinical work carried out with CaPTHymone™ we are confident that we will be able to meet these requirements. We are also pleased that the FDA has recognised the product development and regulatory strategy which Bone initiated 2-3 years ago. The challenges set by the FDA for CaPTHymone™, in comparison with new chemical entity drugs, are in general less expensive, and with the right level of funding be finalised over the next few years.”
Source: Bone Medical Limited