Wired News – ObsEva Released Positive Top-line Results from IMPLANT2 Phase-3 Clinical Trial Evaluating Nolasiban in IVF
Stock Monitor: Blueprint Medicines Post Earnings Reporting
LONDON, UK / ACCESSWIRE / February 28, 2018 / Active-Investors.com has just released a free research report on ObsEva S.A. (NASDAQ: OBSV). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=OBSV as the Company’s latest news hit the wire. On February 26, 2018, the clinical-stage biopharmaceutical Company announced that it has released positive top-line results of the IMPLANT2 Phase-3 clinical trial evaluating nolasiban, which is being developed for improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Follow-up data from the IMPLANT2 study will include live birth rate, and 28-day neonatal safety, expected to be reported in the fourth quarter of 2018.
IMPLANT2 Clinical Trial
IMPLANT2 is a randomized, double blind, placebo controlled clinical trial assessing nolasiban compared to placebo for improving the rate of pregnancy in patients undergoing IVF or ICSI due to low fertility. The study enrolled 778 patients from 41 fertility clinics across nine European countries. Following ovarian stimulation, egg retrieval and fertilization, prospective patients received either a single 900 mg dose of nolasiban or placebo orally on the day of embryo transfer (ET). Recruitment included patients undergoing single, fresh ET on day 3 or on day 5 after oocyte retrieval. The primary endpoint of the trial was ongoing pregnancy as determined by ultrasound at 10 weeks following ET.
Primary Endpoint of the Clinical Trial was Met
These top-line results included efficacy and safety data up to week 10 of pregnancy following embryo transfer. The primary endpoint of the clinical trial was met, with an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1%, representing a relative increase of 25% in the ongoing pregnancy rate after administration of nolasiban compared to placebo. In the ET D5 subgroup, the absolute increase was 11.2% in favor of nolasiban, representing a relative increase in ongoing pregnancy rate of 32% after administration of nolasiban compared to placebo. In the ET D3 subgroup, there was a statistically non-significant 3.1% absolute increase in favor of nolasiban, or a 14% relative increase in ongoing pregnancy rate after administration of nolasiban compared to placebo. Nolasiban was well tolerated, with low rates of treatment discontinuation, and its safety profile was similar to placebo’s. No serious adverse events were reported.
Results Represent a Highly Clinically Meaningful Improvement for the Women Undergoing IVF/ICSI Procedures
Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva, stated that the Company is pleased that the IMPLANT2 results demonstrate an ongoing pregnancy benefit at 10 weeks following a single, oral dose of nolasiban, given 4 hours prior to a single ET, that not only was statistically significant, but the magnitude of which will represent a highly clinically meaningful improvement for the women undergoing IVF/ICSI procedures. Ernest added that IMPLANT2 results potentially represent one of the most important innovations in the practice of IVF/ICSI since the emergence of recombinant FSH more than 20 years ago.
About Nolasiban
Nolasiban is an oral oxytocin receptor antagonist with the potential to decrease contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation. This may increase the chance of successful implantation and live-birth rates among patients undergoing ART. ObsEva licensed nolasiban from Merck-Serono in 2013 and retains worldwide, exclusive, commercial rights.
About Assisted Reproductive Technology
Assisted reproductive technology (ART) is the technology used to achieve pregnancy in procedures such as fertility medication, in vitro fertilization, and surrogacy. It is reproductive technology used primarily for infertility treatments. It mainly belongs to the field of reproductive endocrinology and infertility and may also include intracytoplasmic sperm injection (ICSI) and cryopreservation. Some forms of ART are also used with regard to fertile couples for genetic reasons. While the success of ART depends on multiple factors such as embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation.
About ObsEva S.A.
Founded in 2012 and headquartered in Switzerland, ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy.
Stock Performance Snapshot
February 27, 2018 – At Tuesday’s closing bell, ObsEva’s stock was slightly up 0.76%, ending the trading session at $14.61.
Volume traded for the day: 49.61 thousand shares, which was above the 3-month average volume of 35.63 thousand shares.
Stock performance in the last month – up 35.28%; previous three-month period – up 46.25%; past twelve-month period – up 4.43%; and year-to-date – up 49.69%
After yesterday’s close, ObsEva’s market cap was at $509.74 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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