Oral Calcitonin Product Advances

Article

The ORACAL trial of Tarsa Therapeutics, Inc.'s oral calcitonin product has completed patient enrollment in a multinational, randomized, double-blind, placebo-controlled Phase III trial. The product is for the treatment of postmenopausal osteoporosis. Additionally, the trial completed two separate safety reviews of patient data by an independent data monitoring committee and is set to proceed as planned.

The ORACAL trial of Tarsa Therapeutics, Inc.’s oral calcitonin product has completed patient enrollment in a multinational, randomized, double-bloind, placebo-controlled Phase III trial. The product is for the treatment of postmenopausal osteoporosis. Additionally, the trial completed two separate safety reviews of patient data by an independent data monitoring committee and is set to proceed as planned.

“These are promising developments as we advance our once-daily oral calcitonin tablet that has the potential to offer patients the proven safety and efficacy of calcitonin with the significant advantage of easier administration and the potential for enhanced long-term compliance,” said David Brand, president and CEO of Tarsa, in a press release. “We are delighted that enrollment in the ORACAL trial has proceeded so well and that the DMC has confirmed that there are no safety issues that prevent us from continuing the trial as planned. We look forward to reporting data from the complete Phase III study next year.”

The product is available only in intranasal and injectable forms. Previously, it has been shown to reduce levels of bone resorption biomarkers.

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