Interim Results

RNS Number : 6341L

Ovoca Bio PLC

14 September 2021

 

Ovoca Bio plc

("Ovoca" or the "Company")

Interim Results for the six months ended 30 June 2021

Dublin, Ireland, 14 September, 2021 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, is pleased to announce its interim financial statements and report covering the six-months ending 30 June 2021.

Please click on the following link to view the full Half Year Report:

http://www.rns-pdf.londonstockexchange.com/rns/6341L_1-2021-9-13.pdf

Highlights:

· More than 50 per cent. of patients enrolled in the Phase II dose ranging study assessing BP-101 being conducted in Australia and New Zealand

· Following a publication in the World Health Organization's International Non-proprietary Names for Pharmaceutical Substances, BP-101 will now be referred to as "orenetide"

· Marketing Authorisation ("MA") application for orenetide updated and refiled with the Russian Ministry of Health (the "Minzdrav") and a decision is expected by the end of 2021

· Investment in a new manufacturing process and source in Europe

· €9.3 (US$11.0) million in cash and cash equivalents as at 30^th June 2021, compared to €10.7 (US$13.2) million as at 31^st December 2020.

Letter from the CEO

During the period, Ovoca has maintained its focus on the development of novel treatments in areas of unmet medical need in the women's health sector, continuing to make progress in the development of BP-101, a first-in-class treatment for women with hypoactive sexual desire disorder (HSDD), a condition characterized by a distressing lack or loss of sexual desire.

We are pleased to report that following a publication in the World Health Organization's International Non-proprietary Names for Pharmaceutical Substances, orenetide has been confirmed as the new  generic name for BP-101. This recognition by the WHO marks a welcome step forward for Ovoca as we await a decision from the Russian Ministry of Health (Minzdrav) on approval of the product in the Russian Federation based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study conducted in Russia.

In December 2020 Ovoca submitted an updated Marketing Authorisation application for orenetide to the Minzdrav , with a decision anticipated by the end of 2021. A positive approval will facilitate   a pathway towards commercialisation of the product within the Russian Federation. To this end, and in line with our stated strategy, Ovoca is pursuing potential partnering arrangements with the manufacturer of orenetide in Russia for its distribution and sale there. We will provide an update to the market once those are finalised.

A previous MA submission filed with the Minzdrav in October 2020 was not approved due to concerns relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. However, our understanding was that this was not in any way related to the safety or efficacy of orenetide itself, or the data provided in support of this. As previously reported, the concerns raised by the Minzdrav have now been fully addressed, including the CMC issues in conjunction with our product supplier for the Russian market.

With respect to development for more profitable international markets, in January 2021 Ovoca announced that the first patient had been enrolled in our clinical study being undertaken in Australia and New Zealand aimed at providing further data to validate orenetide internationally. The Phase II, double-blind, placebo-controlled, dose ranging study of orenetide is now more than 50 per cent. enrolled towards the study target. Initially it was anticipated that recruitment would be completed by the end of 2021, but with recent and restrictive measures being taken by the Australian authorities to slow the spread of COVID-19, the recruitment rate into the trial has been impacted. As a result of this, our current expectation is that recruitment is now likely to complete in the first half of 2022.

In parallel with our clinical development activities, we are collaborating with one of the leading European peptide manufacturers to produce orenetide under an improved manufacturing process. In the short term, this is intended to deliver sufficient material to support the upcoming long-term toxicological assessments, as required by the US Food and Drug Association and regulatory authorities in Europe and, longer term, our future clinical work and commercialisation plans for orenetide internationally.

With few treatments available, there remains a high unmet medical need for patients suffering from hypoactive sexual desire disorder (HSDD), one of the most common female sexual problems globally, with an estimated one in ten premenopausal women affected.   As previously reported, having reviewed clinical data from the Phase II and Phase III trials conducted in Russia, orenetide may also be effective as a treatment for Female Orgasmic Disorder. Research suggests that orgasmic difficulty affects 16-28% of women in the United States, Europe, Central and South America, and Mainland China, making it the second most frequently reported female sexual dysfunction. The business is currently exploring how best to investigate orenetide's potential treatment effect in this patient population. 

We are pleased to note also that the business retains a firm capital base, with €9.3 (US$11.0) million in cash and cash equivalents at 30^th June 2021 ( compared to €10.7 (US$13.2 )   million as at 31^st December 2020) and, notwithstanding the continuing uncertainties created by the COVID pandemic, we remain cautiously optimistic about future trading prospects and operating conditions. The Board continues to work hard to achieve our vision to become a leader in the research and development of, and commercial partner of choice for, novel medicines in areas of high unmet need that affect women. I would like to take this opportunity to thank our shareholders for their continue support. We look forward to providing further updated on both our corporate and clinical activities.

End

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel [phone]

[e-mail]

Davy (Nominated Adviser, Euronext Growth Advisor and Broker)

John Frain / Daragh O'Reilly

Tel: [phone]

Consilium Strategic Communications

Chris Gardner, Chris Welsh, Carina Jurs

[e-mail]

Tel: [phone]

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).

The Company's lead product, orenetide (also referred to as BP-101), a novel synthetic peptide administered through a nasal spray, is clinically validated, with Phase II and Phase III studies conducted in Russia 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, as well as obtain marketing approval in the Russian Federation. 

 

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