Last checked at 12 Jun 2023 07:00
Ovoca Bio plc
("Ovoca" or the "Company")
Ovoca Bio Provides Update on Completion Timelines for Phase II Dose Ranging Study Assessing Orenetide for HSDD
Dublin, Ireland, 12 June 2023 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, today announces an update regarding the completion timeline of its ongoing Phase II dose ranging study assessing Orenetide (the "Study"), a novel treatment for women with hypoactive sexual desire disorder ("HSDD"), which is being conducted in Australia and New Zealand. The Company has been informed by its retained Australian Contract Research Organisation (CRO) that, 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. 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.
Dr. Daniil Nemenov, SVP for Clinical Development & Operations at Ovoca, expressed the company's position regarding the delay, stating, "the team here at Ovoca believe the results of this Study are of great significance to our stakeholders, patients, and the broader medical community. Our team has been working diligently with the CRO to address the challenges encountered, and we remain committed to completing the Study in the most efficient and accurate manner possible."
Ovoca would like to emphasize that this delay does not impact the overall commitment and dedication towards advancing Orenetide research and delivering therapeutic solution to patients. The Company's primary focus remains on ensuring patient wellbeing, adhering to rigorous scientific approach, and maintaining the highest standards of quality throughout the Study.
Ovoca will keep shareholders updated should there be any further developments or changes in respect of the revised timeline and the Company looks forward to sharing the results of the Study in due course.
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For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
info@ovocabio.com
Davy (Nominated Adviser, Euronext Growth Listing Sponsor and Broker)
Ivan Murphy / Daragh O'Reilly
Tel: +353 1 679 6363
About Ovoca Bio
Ovoca Bio is a European-based biopharmaceutical company with a focus on women's health. The Company is currently developing a novel treatment for women with hypoactive sexual desire disorder (HSDD), a condition characterized by a distressing lack or loss of sexual desire affecting an estimated ~4 million premenopausal women in the US alone.
The Company's lead product, Orenetide (earlier - BP-101), a novel synthetic peptide administered through a nasal spray, is clinically validated, with earlier conducted regional Phase II and Phase III studies demonstrating statistically significant improvement in a number of key efficacy outcomes, including an increase in female sexual desire and reduction of symptoms of distress associated with HSDD.
Ovoca Bio is seeking to develop the drug for major global markets - in particular the United States and Europe.