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: +7 495 916 60 29 Email: k.golovanov@ovocabio.com
Chris Wiltshire, Director
Tel: +44 7393 873116 Email: c.wiltshire@ovocabio.com
Davy (Nominated Adviser, Euronext Growth Advisor and Broker)
John Frain / Daragh O'Reilly
Tel: +353 1 679 6363
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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END
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