HBM Healthcare Investments : ObsEva Starts Phase 3 Clinical Program for Nolasiban in ART

News & vents

OVA IN TH NW

 using this site, ou consent to the placing of cookies on our computer or device to improve our

rowsing experience in accordance with our Privac Polic. Allow Cookies

Osva tarts Phase 3 Clinical Program for Nolasian in ART

07 Mar 2017

- IMPLANT2 stud to conꦎ�rm eꄛ�cac and safet of novel, oral oxtocin receptor antagonist in infertile patients undergoing emro transfer as part of assisted reproductive technolog (ART) -

GNVA, WITZRLAND, 07 March, 2017 - Osva A (Nasdaq: OV), a wiss iopharmaceutical compan focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnanc, toda announced initiation of its Phase 3 clinical program evaluating the eꄛ�cac and safet of nolasian to improve pregnanc and live irth rates in women undergoing ART. The stud is eing conducted in 10 uropean countries.

Nolasian is an oral oxtocin receptor antagonist that potentiall improves pregnanc and live irth rates following emro transfer (T). In a completed Phase 2 stud, 43 percent of patients treated with 900 mg of nolasian efore T achieved a live irth compared to 29 percent of patients who received placeo.

"ased on our promising Phase 2 data, we are starting a large conꦎ�rmator stud to assess the eꄛ�cac and safet of a single, oral administration of 900 mg of nolasian efore emro transfer on either Da 3 or Da 5 following egg retrieval," said rnest Loumae, MD, PhD, O&GYN, CO and Co-Founder of Osva. "We elieve that should this trial conꦎ�rm an asolute increase in live

irth rates of aout 10 percent, or greater, it would represent a major advance for the patients undergoing these demanding procedures to fulꦎ�ll their desire to have a child."

The IMPLANT2 clinical trial is eing conducted at approximatel 50 fertilit clinics across urope, and is expected to enroll aout 760 women who are undergoing assisted reproduction  in vitro fertilization (IVF) or intractoplasmic sperm injection (ICI) for low fertilit. Following ovarian stimulation, egg retrieval and fertilization, eligile women will e randomized to receive either a single oral dose of 900 mg nolasian or placeo a few hours efore Da 3 or Da 5 T. Treatment allocation will e linded. A pregnanc test will e done after two weeks and pregnancies conꦎ�rmed  ultrasound at 6 and 10 weeks. The primar outcome is ongoing pregnanc at 10 weeks after T. Women with conꦎ�rmed pregnancies will e monitored until the irth of their aies. aies will e monitored for one to six months after irth.

Aout Assisted Reproductive Technolog

Infertilit aꦎ�ects aout 10 percent of reproductive-aged couples, with approximatel 1.6 million ART treatments (including IVF and ICI) performed worldwide each ear.

While the success of ART depends on multiple factors such as emro qualit and T procedure, a successful pregnanc ultimatel hinges on the receptivit of the uterus to accept emro implantation. Uterine contractions at the time of T, as well as suoptimal thickness of the uterine wall and lood ꄛ�ow to the uterus, ma impair the implantation of the emro.

Aout Nolasian

Nolasian (previousl known as O001), is an oral oxtocin receptor antagonist with the potential to decrease contractions, improve uterine lood ꄛ�ow and enhance the receptivit of the endometrium to emro implantation, all of which ma increase the chance of successful pregnanc and live-irth among patients undergoing ART. Osva licensed nolasian from Merck-erono in 2013 and retains worldwide commercial rights.

Aout Osva

Osva is a clinical-stage iopharmaceutical compan focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnanc. Through strategic in-licensing and disciplined drug development, Osva has estalished a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine ꦎ�roids, preterm laor and improving ART outcomes. Osva is listed on The NADAQ Gloal elect Market and is trading under the ticker smol "OV". For more information, please visit www.Osva.com.

Cautionar Note Regarding Forward-Looking tatements

An statements contained in this press release that do not descrie historical facts ma constitute forward-looking statements as that

term is deꦎ�ned in the Private ecurities Litigation Reform Act of 1995. These statements ma e identiꦎ�ed  words such as "elieve", "expect", "ma", "plan," "potential," "will," and similar expressions, and are ased on Osva's current eliefs and expectations. These forward-looking statements include expectations regarding the trial design of O001, including total enrollment, as well as the potential eneꦎ�ts of O001. These statements involve risks and uncertainties that could cause actual results to diꦎ�er materiall from those reꄛ�ected in such statements. Risks and uncertainties that ma cause actual results to diꦎ�er

materiall include uncertainties inherent in the conduct of clinical trials, Osva's reliance on third parties over which it ma not

alwas have full control, and other risks and uncertainties that are descried in the Risk Factors section of Osva's Registration

tatement on Form F-1, as amended, declared eꦎ�ective  the ecurities and xchange Commission (C) on Januar 25, 2017, and other ꦎ�lings Osva makes with the C from time to time. These documents are availale on the Investors page of Osva's wesite at http://www.oseva.com. An forward-looking statements speak onl as of the date of this press release and are ased on information availale to Osva as of the date of this release, and Osva assumes no oligation to, and does not intend to, update an forward-looking statements, whether as a result of new information, future events or otherwise.

 using this site, ou consent to the placing of cookies on our computer or device to improve our

rowsing experience in accordance with our Privac Polic. Allow Cookies

###

Media Contact: Liz ran

pectrum cience lran@spectrumscience.com 202-955-6222 x2526

Compan Contact: Delphine Renaud Osva, CO Oꄛ�ce

delphine.renaud@oseva.ch

+41 22 552 1550

Media Contact

Liz ran

pectrum

+1 (202) 955 6222

lran@spectrumscience.com