Ovoca Bio PLC Primary Endpoints Met in Libicore Phase III Study (7919T)

TIDMOVB

RNS Number : 7919T

Ovoca Bio PLC

25 March 2019

Ovoca Bio plc's Libicore (BP-101) Meets Primary/Secondary Endpoints in Phase 3 Trial for Hypoactive Sexual Desire Disorder Ahead of Time

-- Phase 3 study of Libicore (BP-101) for hypoactive sexual desire disorder (HSDD) in premenopausal women met the pre-specified primary efficacy endpoint of improvement in number of sexually satisfying events:

o In the trial, Libicore (BP-101) showed a statistically significant increase in the number of satisfying sexual events (SSEs) versus placebo (difference in the mean increase in SSEs of 1.83 (95% CI of 0.28-3.39) at the tested daily dose of 2.52mg (p = 0.016)

-- Statistically significant results versus placebo also were seen in the key registration endpoints of:

o Female Sexual Function Index: Desire Domain (FSFI-D) showed a statistically significant mean increase of 1.14 (0.94-1.34) for Libicore (BP-101) vs. 0.58 (0.38 - 0.78) on placebo, p=0.0001; and,

o The Female Sexual Distress Scale - revised (FSDS-R) Item 13 showed a statistically significant mean reduction of -1.2 (-1.4 to -1.0) vs. -0.7 (-0.9 to -0.5), p=0.0019.

-- The pivotal clinical trial, evaluating the efficacy and safety of Libicore (BP-101) versus placebo was stopped early based on the achievement of pre-specified efficacy criteria.

-- Following these results, Ovoca anticipates filing for approval of Libicore (BP-101) in the Russian Federation, where the clinical program has been conducted to date, in the 2(nd) Quarter of 2019.

Ovoca Bio plc (LSE: OVB; ISE:OVXA), a biopharmaceutical company focused on identifying and developing novel therapeutics targeting the large unmet needs in the treatment of female sexual dysfunction, today announced positive, statistically significant top-line results from a Phase 3 clinical trial of its first candidate, Libicore (BP-101). Ovoca acquired a majority interest in IVIX LLC (IVIX) in September 2018, a company that has sought to develop and commercialize its investigational drug candidate, Libicore (BP-101), since its formation in 2012.

The pivotal study investigating first-in-class Libicore as an intranasal treatment for premenopausal women diagnosed with hypoactive sexual desire disorder ("HSDD"), met the pre-specified primary efficacy endpoint, and achieved significant outcomes in key supporting secondary endpoints.

Following a planned interim analysis conducted by an independent Data Monitoring Committee (DMC), the DMC recommended to stop the trial early as the primary endpoint has reached its pre-specified criteria for superiority.

"We are excited with the trial result, which achieved clinical and statistical significance in the primary endpoint and key secondary endpoints using validated measurement tools. This represents the successful achievement of one of the key milestones we outlined when we completed the acquisition of IVIX last year." commented Kirill Golovanov, Chief Executive of Ovoca Bio. "With approximately 1-in-10 adult women experiencing a distressing loss of libido and only a single FDA-approved therapy, we believe that Libicore has the potential to address a significant unmet medical need."

Daniil Nemenov, M.D., medical director of the Libicore program, stated, "In our clinical program, Libicore has been used on a daily basis by premenopausal women with HSDD, and consistently shown sustained efficacy after one month of treatment and a further two months follow-up. In this Phase 3 study Libicore provided clinically significant benefit without troublesome side effects to patients. Furthermore, our approach has the strong potential to provide women suffering from HSDD with a convenient dosage form without the need for injections or inconvenient restrictions associated with current treatment options, or those in late stages of development. We look forward to the opportunity to provide a new and differentiated treatment solution."

Mikhail Mikhailov, M.D., sexologist and Phase 3 study investigator said, "The encouraging results obtained in this study are very important for ensuring the continuing development of modern, effective and safe treatments for Russian female patients with a decrease in sexual desire, especially as this medical problem is becoming increasingly common in a stress-filled modern world."

Based on planned discussions with the FDA at an upcoming Type C meeting and with the German national regulatory body, BfArM, including discussion on clinical trial protocols, Ovoca Bio anticipates pivotal clinical trials could start in the USA and European countries in the middle of 2020.

Phase 3 Study Design and Top Line Results

The Libicore Phase 3 study is a randomized, double-blinded, placebo-controlled pivotal study, comparing the efficacy and safety of Libicore (BP-101) versus placebo in premenopausal women diagnosed with HSDD. The Phase 3 study randomized 189 women with HSDD. The primary efficacy analysis population was the modified intent-to-treat (MITT) patient population, consisting of 184 women with HSDD in the Russian Federation. Patients self-administered either 2.52 mg of Libicore (BP-101) or placebo on a daily basis using a nasal inhaler. The double blind or efficacy portion of the study consisted of a 4-week treatment evaluation period followed by an 8-week treatment-free follow-up portion.

According to the clinical trial protocol, which was approved by Ministry of Health of the Russian Federation, the primary endpoint for the Phase 3 clinical trial was the change in the number of satisfying sexual events (SSEs). The other key measures for regulatory approval in the West, Female Sexual Function Index: Desire Domain (FSFI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-R) Item 13 were chosen as secondary endpoints. About the endpoints, SSE's are measured on a daily basis by completion of an electronic patient diary. FSFI-D is a validated patient reported outcome measurement tool of sexual desire in the context of overall sexual function. The FSDS-R Item 13 is a validated patient reported outcome measurement tool of distress related to sexual dysfunction, measuring personal distress associated with low sexual desire.

In an initial review of the safety population (189 patients), Libicore (BP-101) appeared to be well tolerated. There were no treatment-related serious adverse events during the study, and no patients withdrew from the study due to safety issues. The most frequent adverse events were nasal dryness and nasal odour, which was generally mild in nature. The safety profile of Libicore (BP-101) was consistent with prior clinical experience, and no new or unusual safety issues were identified.

About Libicore

Libicore (BP-101) is a novel synthetic peptide, administered through a nasal spray. The nasal spray delivers the drug to olfactory and trigeminal nerves in the nasal cavity where the drug accumulates in the olfactory bulb and then further in the brain. Clinical studies completed to date have demonstrated statistically significant efficacy in treatment of a major form of female sexual dysfunction, namely HSDD. To demonstrate Libicore's suitability for the clinic, IVIX has conducted four clinical trials to date. Two Phase I clinical trials were conducted to estimate the drug's safety and tolerability and one Phase 2a and one Phase 3 to demonstrate both safety and efficacy at the proposed labeled dose.

About Female Sexual Dysfunction and HSDD

Female sexual dysfunction ("FSD") is estimated to affect a significant portion of the female population in US and EU countries. Examples of FSD may include hypoactive sexual desire disorder ("HSDD") and female sexual arousal disorder ("FSAD"). FSD prevalence has been assessed in a number of large population studies. In a research paper published by Shifren J.L. et al(1.) , nearly 10% of premenopausal women in a large US survey reported distressing low desire for sexual activity. According to the Women's International Study of Health and Sexuality(2.) , the prevalence of HSDD ranged from 6-13 per cent. in Europe, and the proportion of women with low desire associated with distress was significantly higher in younger women in comparison with older women.

"Hypoactive sexual desire disorder is the most prevalent form of female sexual dysfunction," said Sheryl A. Kingsberg, Ph.D., Professor of Reproductive Biology at Case Western Reserve University School of Medicine, Division Chief, OB/GYN Behavioral Medicine, at University Hospitals Cleveland Medical Center. "The negative impact that this condition can have on women's quality of life is profound and extends well beyond the bedroom impairing self-image, self-confidence and damaging otherwise stable relationships."

There is only a singe drug in the United States approved for the treatment of FSD, and another one currently under review for regulatory approval by the FDA. Neither have been filed for approval in Europe.

About Ovoca Bio plc

Ovoca Bio plc's goal is to become a leader in the development and commercialization of novel product candidates for the treatment of female sexual dysfunctions. In 2018, Ovoca Bio acquired IVIX and its promising clinical stage asset, Libicore (BP-101), for female sexual dysfunction, an area of significant unmet medical need. The magnitude of demand for treatments for female sexual dysfunction has only recently been recognized, and Ovoca believes it has the potential to become a substantial pharmaceutical market.

Contact information

Ovoca Bio

Kirill Golovanov, CEO

Tel: [phone] Email: [e-mail]

Chris Wiltshire, Director

Tel: [phone] Email: [e-mail]

Davy (Nominated Adviser, Euronext Growth Advisor and Broker)

John Frain / Daragh O'Reilly

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Forward Looking Statements

This press release is not intended to and does not constitute or form any offer, or invitation, or solicitation of any offer to issue, underwrite, subscribe for, or otherwise acquire or dispose of any shares or other securities of Ovoca Bio plc (the "Company") in any jurisdiction or an inducement to enter into investment activity.

No part of this press release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The press release contains forward-looking statements, including statements about the Company's intentions, beliefs and expectations. These statements are based on the Company's current plans, estimates and projections, as well as the Company's expectations of external conditions and events. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Forward - looking statements involve inherent risks and uncertainties, are based on certain assumptions and speak only as of the date they are made. The Company undertakes no duty to and will not necessarily update any such statements in light of new information or future events, except to the extent required by any applicable law or regulation. Recipients of this press release are therefore cautioned that a number of important factors could cause actual results or outcomes to differ materially from those expressed in any forward--looking statements. Past performance is no guide to future performance and persons needing advice should consult an independent financial adviser.

References

1. Shifren JL et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. ObstetGynecol 2008;112 (5); 968-9.

2. Nappi RE, Martini E, Terreno E, et al. Management of hypoactive sexual desire disorder in women: current and emerging therapies. International Journal of Women's Health. 2010; 2:167-175

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March 25, 2019 03:00 ET (07:00 GMT)