AGC Biologics to Produce Hemophilia B Clotting Factor That Catalyst Is Testing in Clinical Trials

AGC Biologics to Produce Hemophilia B Clotting Factor That Catalyst Is Testing in Clinical Trials

AGC Biologics has agreed to produce the hemophilia B clotting therapy that Catalyst Biosciences is testing in clinical trials, the companies announced.

The next step in testing CB 2679d will be a Phase 2b trial in the third quarter of 2018, according to Catalyst, which is based in South San Francisco.

Interim results of an ongoing Phase 1/2 trial indicate that CB 2679d is more effective than a leading approved clotting agent.

Hemophilia B is a genetic disorder caused by missing or defective Factor IX clotting protein. CB 2679d is a synthetic Factor IX clotting agent.

Catalyst’s South Korean partner, ISU Abxis, started the Phase 1/2 trial (NCT03186677) of CB 2679d in June 2017.

One of the study’s objectives is to see how long the agent stays in the body. Another is to see how well different doses of it work.

Interim results showed that an IV dose of CB 2679d was nearly 22 times more potent than a similar dose of BeneFIXPfizer’s standard Factor IX replacement therapy. The U.S. Food and Drug Administration has approved BeneFix for the prevention and control of bleeding episodes, including during surgery.

The interim results suggested that CB 2679d may be a good bleeding-prevention therapy, ISU Abxis reported.

Another finding was that CB 2679d remained in the blood an average of 34 hours, compared with 25 for BeneFIX.

Final results are expected in 2018, Catalyst said.

“AGC Biologics is a world-renowned company with deep expertise in recombinant biologics manufacturing and has successfully worked with Catalyst on our commercial-scale FVIIa marzeptacog alfa program,” Andrew Hetherington, Catalyst’s senior vice president of technical operations, said in a press release.

“We are confident that their manufacturing expertise will allow us to continue our development and advancement of CB 2679d through the clinic [trials] in a timely manner,” he said. “We plan to initiate a Phase 2b study of CB 2679d in individuals with severe hemophilia B in the third quarter of 2018.”

The European Union granted CB 2679d orphan drug status in June 2017 and the FDA in September 2017.

In January of 2018, the South Korean Ministry of Food and Drug Safety agreed to Catalyst’s request to amend the Phase 1/2 trial plan to shorten its duration. The amendment consisted of eliminating a treatment group and reassigning the participants to another group.

The Phase 1/2 clinical trial is still recruiting participants.

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