Drug development start-up Tarsa Therapeutics has rallied its investors for a financing that has totaled $24.5 million, with plans to use part of the cash infusion to move ahead with an application for approval of its experimental osteoporosis treatment.
The young firm, which said in 2009 that it licensed its lead drug from Unigene Laboratories, aims to file an application for FDA approval of the oral recombinant salmon calcitonin for postmenapausal osteoporosis by late this year, after garnering positive Phase III data, according to the firm's release. It's also using some of its financing--which came from existing backers MVM Life Science Partners, Quaker BioVentures, Novo A/S and Unigene--to fund a Phase II study of the treatment to prevent osteoporosis in postmenapausal women with weakened bones. The firm has wrapped up enrollment of the 120-patient, placebo-controlled study.
"We are encouraged by the continued positive developments in our oral calcitonin program," David Brand, Tarsa's president and CEO, said. "We are looking forward to presenting the full set of efficacy and safety data from the ORACAL trial this fall at the ASBMR meeting, the most important U.S. medical meeting in the osteoporosis field. We view the rapid completion of enrollment in our Phase II prevention study as another sign of the potential interest among physicians and patients for access to additional options for managing and preventing osteoporosis."
Tarsa's executives have touted the fact that patients can swallow their version of calcitonin, which is now on the market only in intranasal and injectable forms. As some patients hate to get drug injections, which can pose challenges to getting them to take certain medications as prescribed, Tarsa's drug could be seen as a more convenient alternative.
- here's Tarsa's release