logo
Share SHARE
FONT-SIZE Plus   Neg

Ipsen's Partner Announces Hold Of Phase III Trials Of IB1001 For Hemophilia B

Ipsen's (IPSEF.PK) partner, Inspiration Biopharmaceuticals Inc., was notified by the Food and Drug Administration or FDA that both studies evaluating the safety and efficacy of IB1001, an investigational intravenous recombinant factor IX (rFIX) therapy for the treatment and prevention of bleeding episodes in people with hemophilia B, were placed on clinical hold.

The clinical hold impacts 2 ongoing IB1001 clinical trials such as a phase III study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in adults with hemophilia B, and a phase III study evaluating IB1001 to treat and prevent bleeding episodes in previously treated pediatric subjects with hemophilia B.

The adult study has completed its primary analysis period. Following the FDA's request, Inspiration has notified clinical sites in the U.S. to hold treatment of patients with IB1001. Also, Inspiration Biopharmaceuticals is sharing the FDA directive with regulators in countries outside of the U.S. where the studies are being conducted.

Totally, 86 people with hemophilia B have received IB1001 in trials and, to date, no adverse events related to the development of antibodies to CHO protein have been reported. Moreover, no relationship has been showed between the development of antibodies to CHO protein and the development of any antibodies to factor IX, the company added.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Best Buy Co., Inc. reported lower profit in its first quarter on the absence of last year's CRT settlement proceeds. However, earnings per share topped market estimates significantly with higher comparable sales. Looking ahead, for the second quarter, the company projects higher comparable sales, and also lifted fiscal 2018 forecast for higher growth.In pre-market, shares were gaining 11.9 percent The Federal Communications Commission or FCC will not take any action against CBS Corp.'s "Late Show with Stephen Colbert" despite receiving thousands of complaints about the talk show comedian's controversial joke about President Donald Trump. The U.S. government filed a civil lawsuit on Tuesday against Fiat Chrysler Automobiles, accusing the automaker of installing software in more than 100,000 diesel vehicles to cheat emission controls. The lawsuit alleges that Fiat Chrysler equipped nearly 104,000 light duty diesel vehicles containing 3.0 liter EcoDiesel engines with software functions that were not disclosed to regulators.
comments powered by Disqus
Follow RTT