- Results show NT100 was well-tolerated, no serious adverse events
- Data suggest NT100 may support maternal-fetal tolerance, has potential to complement existing therapies to maximize pregnancy, live birth rates
PALO ALTO, Calif., June 30, 2014 (GLOBE NEWSWIRE) -- Nora Therapeutics, a biotechnology company focused on developing therapeutics to address unmet needs in reproductive medicine, today announced the presentation of Phase 1 data on the safety and tolerability of its lead compound NT100, a novel rhG-CSF being developed for use in repeat implantation failure and recurrent miscarriage. The data will be presented at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting to be held from June 29 to July 2 in Munich, Germany.
"There has been increasing recognition that maternal-fetal tolerance plays a complementary and critical role in the initiation and maintenance of successful pregnancies," said Paul S. Kwon, M.D., Nora's Chief Medical Officer. "This Phase 1 data demonstrates that NT100 is well-tolerated, may support maternal-fetal tolerance and has the potential to complement existing therapies to maximize overall pregnancy and live birth rates."
This was a prospective, randomized, double-blind, placebo-controlled study in 48 healthy women between the ages of 18 and 40. The study included both single- and multi-dose cohorts across three escalating dose levels. Within each of the six cohorts, subjects were randomized 3:1 to receive NT100 or placebo. The study's primary objective was to characterize the safety, tolerability, pharmacokinetic and pharmacodynamic profile of NT100.
Results showed there was no clinical difference in the rates or severity of adverse events between the placebo and NT100 treatment arms. All events were mild-to-moderate in severity with no serious adverse events or drug discontinuations.
Additional information can be found below:
|TITLE:||A prospective, randomized, double-blind, placebo-controlled Ph1 study to characterize the safety, tolerability, pharmacokinetic / pharmacodynamic profile of NT100, a novel rhG-CSF being developed for use during pregnancy|
Nora is currently enrolling the U.K.-based Phase 2 RESPONSE Research Study of NT100 in women with a history of unexplained recurrent miscarriage. The company has completed enrollment in the Phase 2 Thrive-IVF Research Study of NT100 in women with repeated in vitro fertilization (IVF) failures and expects to report top-line data late this year.
For additional information on Thrive-IVF visit: http://clinicaltrials.gov/ct2/show/NCT01864356.
For additional information on ESHRE visit: http://www.eshre2014.eu.
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.