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Obseva to Discontinue Nolasiban IVF Program due to failure of IMPLANT4 Clinical Trials

13 Nov Obseva to Discontinue Nolasiban IVF Program due to failure of IMPLANT4 Clinical Trials

Obseva (NASDAQ: OBSV), a biopharmaceutical Company focused on women’s reproductive health announced the discontinuation of nolasiban (OBE001), an oral oxytocin receptor antagonist intended for women undergoing embryo transfer (ET) following in-vitro fertilization (IVF). The candidate, though well-tolerated, failed to meet the primary endpoint of an increase in ongoing pregnancy rate at 10 weeks (39.1 % placebo vs. 40.5 % nolasiban).

The Company was evaluating the candidate in a phase 3 clinical trial named IMPLANT4, a randomized double blind, placebo controlled clinical trial, which had enrolled 807 patients from more than 40 fertility clinics across nine European countries. Women undergoing a Day 5 transfer of a single, fresh embryo were randomized to receive either a single 900 mg dose of nolasiban or placebo (1:1) 4 hours prior to ET and the ongoing pregnancy was to be determined by ultrasound at 10 weeks following ET.

Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva, commented,

We are extremely disappointed with these unexpected results, not in the least for the millions of women hoping to have a baby through IVF. Based on these results, we have decided to discontinue the current nolasiban IVF program and will explore potential repositioning of the product candidate. We remain more committed than ever to developing our innovative pipeline of late-stage products aimed at unmet needs in uterine fibroids, endometriosis and preterm labor and will focus our resources on these programs immediately.”

Obseva (NASDAQ: OBSV

Market Cap: $121.46M; Current Share Price: 2.76 USDChart
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Industry
Assisted Reproductive Technology is characterised by the surgical removal of eggs from the women’s ovaries to be combined with sperms in a laboratory, and are consequently implanted into the ovaries. The technology helps overcome the problems posed by infertility, while ensuring the genetic connection with the donor is preserved. According to a report, globally over 1.5 million ART cycles are performed annually. However the failure rates associated with this procedure is very steep with nearly 76.7% ART procedures failing and only 23.3% of the procedures culminating in a live birth.

According to data made available by centres for disease control and prevention (CDC), over 10 percent of reproductive-aged couples are afflicted with Infertility and more than 2 million ART treatments (including IVF and ICSI) are performed worldwide each year.

The ART market is further categorised into in-vitro fertilization-embryo transfer (IVF-ET), gamete intrafallopian transfer (GIFT), frozen embryo transfer (FET) and zygote intrafallopian transfer (ZIFT). In-vitro fertilization-embryo transfer (IVF-ET) is the most popular market segment owing to higher chances of success and extensive reimbursement coverage. The evolution and introduction of new technology such as time lapse imaging systems, has eliminated the need for multiple sperm injections. Technological advancements, the growing incidences of infertility, extensive insurance coverage and government support, rise in disposable incomes, lifestyle related diseases such as obesity and stress will propel the growth in this industry.

Company
Obseva aims to leverage its expertise in women’s reproductive health to create pregnancy therapeutics to help women lead safer lives worldwide. The Company’s pipeline consists of nolasiban (OBE001), an oral oxytocin receptor antagonist that can reduce contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, to improve the chances of live-birth in women undergoing embryo transfer following ART.

In addition, its pipeline consists of Linzagolix (previously known as OBE2109), a novel, orally administered GnRH receptor antagonist intended for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. The Company licensed the candidate from Kissei Pharmaceutical (OTCPINK: KSPHF) in late 2015, and retains worldwide commercial rights, excluding Asia. The Company intends file for an NDA by the end of 2020 for Linzagolix, based on the results of a phase 3 Primrose 2&1 trial, the results of which are expected in Q4 2019 / H1 2020.

ObsEva also holds the worldwide, exclusive, commercial rights for OBE022, a selective prostaglandin F2alpha receptor antagonist for the treatment of preterm labor, which was licensed from Merck KGaA, Darmstadt, Germany, in 2015.

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The Company’s growth strategy focuses on building strategic partnerships and acquisition of novel clinical –stage candidates, which are potentially first-in-class and address the unmet needs in the areas of women’s reproductive health medicine, small chemical molecules, peptides, proteins or mAbs.

Risk Assessment

  • Clinical trials are fraught with uncertainty and are unpredictable; therefore it is imperative that a Company builds a diverse pipeline of candidates. Obseva has decided to discontinue the development of Nolasiban for IVF, however it intends to explore the possibilities of repositioning the product.
  • Obseva is now looking forward to the results from two pivotal phase 3 trials for women with uterine fibroids namely PRIMROSE 1 and PRIMROSE 2 and a phase 3 trial called EDELWEISS 2 (U.S.) and EDELWEISS 3 (U.S. and Europe) for endometriosis-associated pain, Additionally it is also continuing a phase 2 study in Europe for OBE022 based on the recommendations of the data monitoring committee.
  • The Company has cash and cash equivalents of $91.0 million as of September 30, 2019, which is adequate to fund its ongoing clinical trials and meet any milestones ensuing in the near future. The failure of the clinical trial will lower its cash burn and extend its cash runway until at least the first quarter of 2021.
  • Obseva enjoys a $75 million senior credit facility agreed with Oxford Finance LLC, out of which it has already withdrawn a first $25 million tranche. The Company will need a positive readout from its Primrose 1 and Primrose 2, to withdraw any further amount as per an agreement between the Companies.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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    Source:          

    https://www.obseva.com/pressrelease-detail/?pr=2714

    https://www.zebvo.com/2019/11/11/assisted-reproductive-technology-market-pegged-for-robust-expansion-during-2015-2021/

    https://www.obseva.com/pressrelease-detail/?pr=2721

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