CRO issues dampen Ovoca Bio’s drive to get female sexual desire drug approved
14 Jun 2023
Phase 2
Preview
Source: FierceBiotech
Staffing problems at an Australian CRO forced Ovoca Bio to suspend a phase 2 trial of its drug to treat women with hypoactive sexual desire disorder, sending its stock lower.
Ovoca Bio said staffing issues at an Australian CRO caused the Irish biotech to suspend a phase 2 trial of its novel treatment for women with hypoactive sexual desire disorder.
News of the delay, which was released by the company Monday, caused shares of Ovoca Bio to tumble as much as 17% in early trading in London after the warning was issued. For a 12-month period, shares have declined 35%.
The company said the delay won’t impact its commitment and dedication toward advancing Orenetide research and delivering a therapeutic solution to patients, which is a novel synthetic peptide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
“Due to issues with staffing levels at the CRO, the timeline for delivery of the results of the study has been delayed, with the results now anticipated to be finalized in August as opposed to the previously anticipated timeframe of June this year,” the company said in a statement. “While this is disappointing, the staffing issues have now been resolved and Ovoca wishes to assure its stakeholders that every effort is being made to expedite the completion and ensure the accuracy and reliability of the results of the study.”
The first FDA-approved drug to treat the disorder dates back to 2015 when the regulatory agency gave its nod to Addyi (flibanserin).
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