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news.Tarsa Therapeutics has completed patient recruitment in the Oracal trial of its oral Calcitonin product for the treatment of postmenopausal osteoporosis.
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Oracal trial is a multinational, randomised, double-blind, placebo-controlled Phase III trial designed to enroll about 550 patients.
Tarsa Therapeutics also stated that the independent Data Monitoring Committee (DMC) for the Oracal trial has completed two separate safety reviews of patient data and recommended that the progression of the trial as planned.
Calcitonin product, in the prior clinical studies, has been shown to deliver the desired blood levels of Calcitonin and reduce levels of bone resorption biomarkers.
Tarsa Therapeutics said that Calcitonin has received approval for the treatment of postmenopausal women with osteoporosis, but its use has been limited as it is currently available only in intranasal and injectable forms.
Additionally, Tarsa Therapeutics has received FDA approval for the commercial availability of Calcitonin.
David Brand, president and CEO of Tarsa, said: “These are promising developments as we advance our once-daily oral Calcitonin tablet. 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.”