Breaking News
January 16, 2019 - Questions to ask your doctor about post pregnancy care: MedlinePlus Medical Encyclopedia
January 16, 2019 - Neurons with good housekeeping are protected from Alzheimer’s
January 16, 2019 - Is mindfulness worthy of all the hype?
January 16, 2019 - Physical Activity, Any Type or Amount, Cuts Health Risk from Sitting
January 16, 2019 - New understanding in the evolution of human feet
January 15, 2019 - AHA: New Cholesterol Guidelines Put Ethnicity in the Spotlight
January 15, 2019 - Different brain areas linked to smoking and drinking
January 15, 2019 - Henry Marsh shares insights into neurosurgery and more at Dean’s Lecture Series
January 15, 2019 - Want to Live Longer? For Just 30 Minutes a Day, Do Anything Else But Sit
January 15, 2019 - The Current issue of “The view from here” is concerned with Targets
January 15, 2019 - Plain packaging sparked tobacco price rises, new study finds
January 15, 2019 - Sedentary lifestyles can be unhealthy, physical activity can lower risk
January 15, 2019 - Gut microbiome may help prevent development of cow’s milk allergy
January 15, 2019 - Lesbian, gay and bisexual individuals more likely to suffer severe substance use disorders
January 15, 2019 - New England Journal of Medicine Publishes Positive Results of the Pivotal Trial of Cablivi (caplacizumab) for Rare Blood Clotting Disorder
January 15, 2019 - Levels of inflammatory marker (CRP) linked to housing type and tenure
January 15, 2019 - Three gifts I’m glad I gave myself in 2018
January 15, 2019 - Columbia’s Pediatrics Department Names New Vice Chairs, Expands Leadership
January 15, 2019 - US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
January 15, 2019 - Staying fit can cut your risk of heart attack by half
January 15, 2019 - Vitamin D supplements are of no gain to those over 70, study shows
January 15, 2019 - Scientists create comprehensive new method to predict breast cancer risk
January 15, 2019 - Research shows connection between social media use and impaired risky decision-making
January 15, 2019 - FDA Approves Expanded Use of Adacel (Tdap) Vaccine for Repeat Vaccination
January 15, 2019 - Treating spinal pain with replacement discs made of ‘engineered living tissue’ moves closer to reality
January 15, 2019 - Providers Walk ‘Fine Line’ Between Informing And Scaring Immigrant Patients
January 15, 2019 - Outcomes Poorer for Medicaid Beneficiaries With STEMI
January 15, 2019 - Decorative Products on Foods Can Be Unsafe
January 15, 2019 - A dream of sustainable surgery in Uganda
January 15, 2019 - Study shows how herpes viruses and tumors have learned to manipulate the same ancient RNA
January 15, 2019 - Common Heart, Diabetes Meds May Help Ease Mental Illness
January 15, 2019 - Stress and trauma in earliest years linked to reduced hippocampal volume in adolescence
January 15, 2019 - Scientists identify endogenous activator of sigma-1 receptors in human cells
January 15, 2019 - MAR treatments unlikely to be cause of premature or low birth weight babies
January 15, 2019 - Parental CPTSD increases transmission of trauma to offspring of Tutsi genocide survivors
January 15, 2019 - High-fat diets shown to increase blood pressure
January 15, 2019 - New institute for food safety to be established in Netherlands
January 15, 2019 - Keele University researchers receive £2.4 million grant to help reduce overprescribing of opioids
January 15, 2019 - Synthetic compound reverses mutant p53 aggregate accumulation, study shows
January 15, 2019 - First elder care robot tested in a WSU smart home apartment
January 15, 2019 - Oxford researchers explore relationship between technology use and adolescent mental health
January 15, 2019 - From microbiome research to healthier and sustainable foods
January 15, 2019 - How coaching moms and dads improves infants’ language skills
January 15, 2019 - Precision health approach tapped to identify causes of poverty
January 14, 2019 - DNA origami can accurately measure how antibodies interact with several antigens
January 14, 2019 - Researchers identify multiple new subtypes of most common childhood cancer
January 14, 2019 - Total Fertility Rates Vary by State
January 14, 2019 - Elevated blood lead level in early childhood associated with increased risk of academic problems in school-aged children
January 14, 2019 - Superior technique identified that can block CRISPR gene editing
January 14, 2019 - Turning breast cancer cells into fat cells prevents the formation of metastases
January 14, 2019 - Review examines what influences HIV-positive patients to stay on antiretroviral drugs in Africa
January 14, 2019 - Identifying genetic factors that lead to squamous cell carcinoma
January 14, 2019 - Virtual video visits can replace office visits without compromising quality of care
January 14, 2019 - Health Highlights: Jan. 10, 2019
January 14, 2019 - Molecular hallmarks of tumor hypoxia across 19 cancer types discovered
January 14, 2019 - Scientists uncover how protein clumps damage cells in Parkinson’s
January 14, 2019 - Physician-scientist’s “indomitable spirit” prevails over personal adversity
January 14, 2019 - King’s researchers receive £1.25 million to investigate fatal eating disorder
January 14, 2019 - UCR researchers uncover how plants sense temperature
January 14, 2019 - Scientists find link between colitis and colon cancer
January 14, 2019 - New skin patch provides long-acting contraceptive protection
January 14, 2019 - Asparagine synthetase deficiency – Genetics Home Reference
January 14, 2019 - Improved stem cell approach could aid fight against Parkinson’s
January 14, 2019 - New class of sleeping pill preserves ability to wake in response to danger signals
January 14, 2019 - Cancer patients are four times more likely to commit suicide
January 14, 2019 - The human brain works in reverse order to retrieve memories
January 14, 2019 - Simple tips can lead to better food choices
January 14, 2019 - Meth’s Resurgence Spotlights Lack Of Meds To Combat The Addiction
January 14, 2019 - TARA Biosystems and Insilico Medicine collaborate to discover novel therapies for cardiac disease
January 14, 2019 - Early life stress in mice affects their offspring behavior
January 14, 2019 - Depression Tied to Worse Asthma Outcomes in Urban Teens
January 14, 2019 - Santa calorie counting
January 14, 2019 - Opiod prescriptions for pet dogs misused by their masters
January 14, 2019 - People with ASD could be better at recognizing regret and relief in others finds study
January 14, 2019 - Conducting ChIP-Seq with Low Cell Numbers
January 14, 2019 - Study explores support and social networks of family carers of people with dementia
January 14, 2019 - At Risk for an Opioid OD? There’s an App for That
January 14, 2019 - Single national electronic health record will help improve care in Canadian hospitals
January 14, 2019 - Study unearths Britain’s first speech therapists
January 14, 2019 - Study reveals nuances of racial inequalities in breast cancer prevention
ObsEva SA Presents Clinical Data from Phase III IMPLANT 2 Trial of Nolasiban in IVF at the American Society of Reproductive Medicine (ASRM) Annual Meeting

ObsEva SA Presents Clinical Data from Phase III IMPLANT 2 Trial of Nolasiban in IVF at the American Society of Reproductive Medicine (ASRM) Annual Meeting

image_pdfDownload PDFimage_print

Geneva, Switzerland and Boston, MA – October 9, 2018 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced that IMPLANT 2 Phase 3 clinical data of its novel, oral, oxytocin receptor antagonist, nolasiban, in patients undergoing IVF were presented at the 74th annual meeting of the American Society of Reproductive Medicine (ASRM), taking place in Denver, Colorado, October 6-10, 2018.

“We feel honored that our commitment to improve the chances of success of IVF treatments is recognized by the award for IMPLANT 2 from SART, the primary organization of professionals dedicated to the practice of Assisted Reproductive Technologies (ART) in the United States. In addition, the new data showed an increase in live births resulting from a single nolasiban administration prior to embryo transfer (ET) which represents extremely important efficacy and safety follow-up from both a clinical trial and patient perspective,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. “We are continuing our nolasiban clinical development to bring the first treatment at the time of ET, to couples experiencing infertility and undergoing IVF treatment that can improve not only the likelihood of achieving pregnancy, but also the ultimate goal of bringing home a baby.”

In the oral presentation entitled “A Placebo-controlled, Randomized, Double Blind, Phase 3 Study Assessing Ongoing Pregnancy Rates After Single Oral Administration of a Novel Oxytocin Receptor Antagonist, Nolasiban, Prior to Single Embryo Transfer” the primary endpoint results of the IMPLANT 2 trial showed an improvement in the rate of ongoing pregnancy 10 weeks post either Day 3 or Day 5 ET, with nolasiban treatment vs. placebo, 35.6% vs. 28.5% (p=0.031), a 25% increase. For women undergoing Day 5 ET, nolasiban resulted in an ongoing pregnancy rate of 45.9% vs. 34.7% for placebo (p=0.034), a 32% increase.

New data of this trial presented on live birth rate (LBR), also known as “Take Home Baby rate”, showed that nolasiban treatment resulted in an improvement that was both statistically and clinically significant. Treatment with a single nolasiban 900 mg oral dose 4h prior to ET resulted in a live birth rate of 34.8% vs. 27.7% for patients receiving placebo (p=0.025), a 26% increase. The live birth rates from women undergoing Day 5 ET were 44.8% for those receiving nolasiban, vs. 33.2% for those receiving placebo (p value=0.025), a 35% increase.

Importantly, the tolerability and safety profile of nolasiban has been observed to be comparable to placebo, with no increase in serious adverse events, in ectopic pregnancy, nor in congenital birth defects. In addition, a secondary endpoint of miscarriage rate from weeks 2 to 24 of gestation showed a favourable impact from nolasiban treatment suggesting a reduced miscarriage rate following nolasiban treatment compared to placebo.

ObsEva recently announced regulatory feedback from authorities in Europe and, as initially planned, is proceeding with an additional Phase 3 clinical trial of nolasiban. This trial is expected to begin screening patients before the end of 2018, and will enroll up to approximately 1,000 patients undergoing IVF. Primary endpoint results measuring ongoing pregnancy rate 10 weeks post ET from this trial are anticipated before the end of 2019, and with positive results are intended to support Marketing Authorisation Application filing in the EU.

About the IMPLANT2 Clinical Trial

IMPLANT 2 is a Phase 3, randomized, double blind, clinical trial assessing nolasiban compared to placebo for improving the rate of pregnancy in patients undergoing IVF or ICSI. Following ovarian stimulation, egg retrieval and fertilization, eligible women are randomized to receive either a single, oral dose of 900 mg nolasiban or placebo 4 hours before Day 3 or Day 5 fresh, single ET. The primary endpoint is ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies are monitored until delivery and the infants for up to 6 months following birth.

About Assisted Reproductive Technology (ART)

Infertility affects about 10 % of reproductive-aged couples, with more than 2 million ART treatments (most being IVF) performed worldwide each year. Currently 59% of fresh embryo transfers are performed on Day 5 and 31% on Day 3 in the United States (CDC report, 2015 data).

While the success of ART depends on multiple factors including ovarian response, fertilization, embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and reduced blood flow to the uterus, may impair the implantation of the embryo.

About Nolasiban

Nolasiban (previously known as OBE001), is a novel, oral, oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART. ObsEva licensed nolasiban from Merck KGaA, Darmstadt, Germany, in 2013 and retains worldwide, exclusive, commercial rights.

About ObsEva

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. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

Cautionary Note Regarding Forward Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2017, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ObsEva SA

Posted: October 2018

About author

Related Articles