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OBE022 is a first-in-class, articulate and careful PGF2alpha receptor adversary for the abeyant analysis of preterm activity to adjournment or anticipate preterm birth
Geneva, Switzerland and Boston, MA – December 5, 2017 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical aggregation focused on the development and commercialization of atypical analysis for austere altitude that accommodation a woman’s changeable bloom and pregnancy, today appear the admission of its all-embracing Phase 2a Proof-of-Concept analytic trial, PROLONG.
The PROLONG balloon is the aboriginal analytic balloon of OBE022 in abundant women presenting with ad-lib preterm activity at gestational ages amid 24 and 34 weeks. OBE022 will be administered orally for 7 days calm with standard-of-care tocolytic therapy, 48 hour intravenous beverage of atosiban.
“According to a contempo United Nations Report, in 2016, 7,000 babies died every day in the aboriginal 28 canicule of life, admitting a abiding abatement in under-five mortality. Preterm bearing complications and complications during activity or adolescent bearing acquired 30% of bairn deaths in 2016,” said Ernest Loumaye, MD, PhD, OBGYN, CEO and Co-Founder of ObsEva. “OBE022 is a careful PGF2alpha receptor adversary that we accept could be a able new analysis for dabbling or preventing preterm birth. The admission of the PROLONG balloon is an important anniversary for ObsEva, as OBE022 is now our third admixture in Phase 2 or afterwards analytic development, and we are absolute admiring to be accommodating with the accomplished analysis teams at some of the better maternology hospitals”.
The PROLONG balloon will be conducted in two parts: In Allotment A, at atomic 8 patients will accept OBE022 open-label to appraise pharmacokinetics and assurance afore basic Allotment B. Allotment B is planned to accommodate 120 patients who will be randomized to OBE022 or placebo in a double-blind fashion. Beyond safety, the ability endpoints in the capital allotment of the balloon will accommodate the admeasurement of patients who accept delivered at 2 or 7 canicule afterwards starting OBE022, at 37 weeks of gestation, and the time to delivery. In both genitalia of the trial, patients will be monitored until delivery. Afterwards birth, mothers and babies will be monitored for an antecedent 28 days, with consecutive 24 ages baby follow-up. ObsEva expects to advertise basic after-effects from 60 patients in Allotment B in backward 2018.
Part A of the PROLONG balloon is actuality conducted in Finland at the Helsinki University Women’s Hospital, one of the better maternology hospitals in Europe, beneath the administering of Professor Seppo Heinonen, the Director of Obstetrics and Gynaecology. “We are absolute admiring to be administering the PROLONG balloon at the Helsinki University Women’s Hospital,” said Professor Heinonen. “There is a above charge for new treatments for preterm activity and we are absolute aflame to be testing the aboriginal admixture in this able new class.”
The PROLONG balloon is additionally planned to be conducted at maternology hospitals in added countries, including Spain, Israel and Vietnam.
About Preterm Labor
Preterm labor, authentic as the bearing action starting above-mentioned to 37 weeks of gestation, is a austere action characterized by uterine contractions, cervical aborticide and breach of the fetal membranes that can advance to preterm birth. According to a abstraction appear in the Lancet in 2012, about 15 million babies were built-in afore 37 weeks of evolution in 2010, accounting for 11.1% of all alive births worldwide. Over 1 actor accouchement beneath the age of bristles died in 2013 common due to preterm bearing complications, and abounding breed who survive preterm bearing are at greater accident for bookish palsy, delays in development, audition and eyes issues, and generally face a lifetime of disability. The ante of preterm births are ascent worldwide, and are associated with an immense banking appulse to the all-around healthcare system.
To date, alone treatments with bound ability or akin assurance issues are accessible to amusement preterm labor. In the United States, recommended first-line tocolytic treatments (medications that arrest labor) accommodate calcium approach blockers, non-specific inhibitors of prostaglandin synthesis, frequently alleged Nonsteroidal Anti-Inflammatory Drugs or NSAIDs, or beta-adrenergic receptor agonists, which are acclimated for concise assiduity of abundance (up to 48 hours) to acquiesce for the administering of antenatal steroids (e.g. betamethasone). Magnesium sulfate, acclimated for fetal neuroprotection can additionally be acclimated (up to 48 hours) to arrest astute preterm labor. Approved tocolytic treatments in Europe accommodate beta-adrenergic agonists, which backpack astringent affectionate cardiovascular risks, and intravenous infusions of atosiban (an oxytocin receptor antagonist).
While NSAIDs are believed to be able for inhibiting preterm labor, use of such drugs is limited, due to the blackmail of austere and sometimes life-threatening ancillary furnishings to the fetus. Such ancillary furnishings may accommodate branch action impairment, abortive binding of the claret barge abutting the pulmonary avenue and the bottomward aorta in a developing fetus, and college accident of occlusion of the abdominal arteries (a action alleged necrotizing enterocolitis).
About OBE022 and PGF2alpha
ObsEva is developing OBE022, a abeyant first-in-class, articulate and careful prostaglandin F2alpha (PGF2alpha) receptor antagonist, which is advised to appulse preterm activity by abbreviation inflammation, abbreviating uterine contractions, preventing cervical changes and fetal film breach after causing the potentially austere ancillary furnishings to the fetus apparent with NSAIDs. PGF2alpha is believed to abet contractions of the myometrium and additionally upregulate enzymes causing cervix aborticide and film rupture. In nonclinical studies, ObsEva has empiric that OBE022 clearly reduces ad-lib and induced uterine contractions in abundant rats after causing the fetal ancillary furnishings apparent with NSAIDs such as indomethacin.
ObsEva is a clinical-stage biopharmaceutical aggregation focused on the analytic development and commercialization of atypical analysis for austere altitude that accommodation a woman’s changeable bloom and pregnancy. Through cardinal in-licensing and acclimatized biologic development, ObsEva has accustomed a late-stage analytic activity with development programs focused on alleviative endometriosis, uterine fibroids, preterm activity and convalescent ART outcomes. ObsEva is listed on The NASDAQ All-around Select Market and is trading beneath the ticker attribute “OBSV”. For added information, amuse appointment www.ObsEva.com.
Cautionary Note Apropos Forward-Looking Statements
Any statements independent in this columnist absolution that do not call absolute facts may aggregate advanced statements as that appellation is authentic in the Private Securities Litigation Reform Act of 1995. These statements may be articular by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and agnate expressions, and are based on ObsEva’s accepted behavior and expectations. These advanced statements accommodate expectations apropos the analytic development of ObsEva’s artefact candidates and the timing of acceptance in and advertisement of abstracts from analytic trials, including the PROLONG analytic trial. These statements absorb risks and uncertainties that could account absolute after-effects to alter materially from those reflected in such statements. Risks and uncertainties that may account absolute after-effects to alter materially accommodate uncertainties inherent in the conduct of analytic trials, ObsEva’s assurance on third parties over which it may not consistently accept abounding control, and added risks and uncertainties that are declared in the Accident Factors area of ObsEva’s Annual Report on Form 20-F for the year concluded December 31, 2016, and added filings ObsEva makes with the SEC. These abstracts are accessible on the Investors folio of ObsEva’s website at http://www.obseva.com. Any advanced statements allege alone as of the date of this columnist absolution and are based on advice accessible to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, amend any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.
Media Contact:Liz BryanSpectrum [email protected] x2526
CEO Office contactShauna DillonShauna [email protected] 41 22 552 1550
Investor ContactMario CorsoSenior Director, Investor [email protected]
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