Press release
Catalyst Biosciences Presents Positive Data from its Phase 2b Trial of Subcutaneous Dalcinonacog Alfa (DalcA) and Marzeptacog alfa (activated) (MarzAA) Programs at the 13th Annual EAHAD Congress
Enrollment in the DalcA trial is complete; results demonstrate DalcA provides Factor IX (FIX) activity exceeding the efficacy endpoint with no anti-drug
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"Enrollment in the DalcA trial is complete; results demonstrate DalcA provides Factor IX (FIX) activity exceeding the efficacy endpoint with no anti-drug antibodies\n Company to host investor call and webcast on Friday, February 7 at 8:30 a.m. ET SOUTH SAN FRANCISCO, Calif., Feb. 07, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced positive efficacy and safety data from its Phase 2b trial of DalcA, a next-generation subcutaneously (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B. The data were presented by Johnny Mahlangu, M.B.B.Ch., M.Med, F.C.Path, professor of haematology, faculty of health sciences, head of the School of Pathology at the University of Witwatersrand in Johannesburg, South Africa, and principal investigator in the clinical trial in an oral presentation at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in The Hague, Netherlands. Data from the trial showed that 28 days of daily SQ dosing of DalcA achieved protective target FIX levels of >12%, with steady state FIX levels of up to 27% after 14 days with no bleeds, demonstrating effective prophylaxis and the potential for lower or less frequent dosing. One subject withdrew on day 7. No anti-drug antibodies were detected and no serious adverse events were reported. Three subjects reported injection site reactions (ISRs), the majority of which were mild in severity and resolved without sequelae. The open-label Phase 2b study was designed to evaluate the ability of DalcA to maintain steady state protective FIX levels above 12% in six individuals with severe hemophilia B. Each subject received a single intravenous dose, followed by daily SQ doses of DalcA for 28 days. Pharmacokinetics, pharmacodynamics, safety and tolerability of daily SQ dosing and anti-drug antibody formation are being monitored. “The DalcA Phase 2b trial data presented today at EAHAD clearly demonstrate the potential for DalcA to significantly change the treatment paradigm for those suffering from hemophilia B,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “With the trial now fully enrolled and one final subject completing dosing, we will announce final data in the second quarter of this year.” Dr. Usman continued, “We are very encouraged by...