Product Pipeline | CaPTHymone™ (BN003) | Capsitonin™ (BN002) | Selective TNF/IL6 Downregulator (BN006)

Bone Cell Regulators (BN005/008) | Joint Protection & Collagen Tolerance Programme (BN007)


(Osteoporosis and other metabolic bone diseases)

Calcitonin is a natural hormone that has been used to treat bone diseases and osteoporosis by injection and nasal spray for years. It has also been shown to exert an analgesic (pain-relief) effect in numerous clinical studies, including osteoarthritis.  Chronic joint pain from osteoarthritis is one of the most significant treatment challenges in aging populations.  Although not currently approved for the treatment of arthritis pain, an effective oral calcitonin could challenge the role of non-steroidal anti-inflammatory drugs, the established therapy of choice for symptomatic relief in arthritis, which have significant toxicity and drug interaction problems in the long-term use that chronic use requires. Oral calcitonin could also replace injected and nasal calcitonin for osteoporosis. Bone’s Capsitonin™ oral calcitonin currently has an approved IND in the US for further clinical studies in osteoporosis and should follow a streamlined regulatory pathway to approval for osteoporosis since it uses a marketed drug for an existing approved use.  Clinical studies of Capsitonin™ to date have confirmed:

  • Oral delivery produced blood levels capable of exerting a statistically significant biological effect similar to that of the approved nasal product
  • The calcitonin used in the oral formulation was measured in the blood, although measurement was and is notoriously difficult;
  • Levels of biological markers in the blood associated with bone breakdown were reduced
  • Calcium levels in the blood were also reduced as expected
  • Oral calcitonin was well tolerated by all the subjects and there was no safety concerns; the oral calcitonin safety profile was comparable to the nasal calcitonin comparator.

Most importantly, Capsitonin™ oral calcitonin contains no new chemical entities,  creating the prospect of a streamlined development program and regulatory pathway to the market.