Nora Therapeutics Announces Initiation of Phase 2 RESPONSE Research Study

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| Source: Nora Therapeutics
  • RESPONSE is Studying NT100 in Pregnant Women With Unexplained Recurrent Pregnancy Loss

PALO ALTO, Calif., June 26, 2014 (GLOBE NEWSWIRE) -- Nora Therapeutics, a biotechnology company focused on developing therapeutics to address unmet needs in reproductive medicine, today announced the initiation of its Phase 2 RESPONSE Research Study of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL).

"We are pleased to announce that the RESPONSE study is open and the first participants are now enrolling," said Jeffrey K. Tong, Ph.D., President and Chief Executive Officer of Nora. RESPONSE is a randomized, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety and tolerability of Nora's lead compound, NT100, in pregnant women with a history of unexplained RPL. The study will enroll approximately 150 women with a history of three or more unexplained miscarriages at 15 to 20 sites across the U.K.

"Recurrent miscarriage is a devastating condition. There are currently no approved therapies for unexplained pregnancy loss. Patients and their doctors are on a desperate search for an effective treatment," said Arri Coomarasamy, Chief Investigator of RESPONSE and a Professor of Gynaecology at the University of Birmingham, U.K. "I am thrilled to be working with Nora Therapeutics and an established network of the U.K.'s leading hospitals and early pregnancy units to study this promising therapy, NT100."

RPL affects between 1 and 5 percent of all women of childbearing age. NT100 is a novel biologic agent similar to a naturally occurring protein in the female reproductive tract, which may better enable embryo implantation and pregnancy maintenance by optimizing maternal-fetal immune tolerance.

"The experience of miscarriage can be deeply distressing, especially if it happens repeatedly," said Ruth Bender Atik, National Director of the U.K.-based Miscarriage Association (http://www.miscarriageassociation.org.uk). "Yet there is no known cause for over half of those affected. We are encouraged that Nora Therapeutics is conducting a rigorous, controlled clinical study of NT100 as a potential new treatment option for women who have been repeatedly affected by miscarriage."

For additional information on RESPONSE visit: www.responseresearchstudy.co.uk or http://clinicaltrials.gov/ct2/show/NCT02156063.

About Nora Therapeutics, Inc.

Nora Therapeutics is a privately held biotechnology company focused on developing therapeutics to address IVF failure and recurrent pregnancy loss, two reproductive conditions with significant unmet need. Nora's lead compound, NT100, is a novel biologic agent similar to a naturally occurring protein in the female reproductive tract and may better enable embryo implantation and pregnancy maintenance by optimizing maternal-fetal immune tolerance. For more information, please visit our website at www.noratherapeutics.com.

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