Regron Announce Decision to Advance Long-Acting Hemophilia B Therapy into a Registrational Trial

Braincure Biotech plans to advance the companies' long-acting, fully-recombinant fusion protein into a registrational clinical trial in hemophilia B patients.

Taipei; 26, December 2015: Braincure Biotech (ISIN:TW0001327872) plans to advance the companies’ long-acting, fully-recombinant fusion protein (FRFP) into a registrational clinical trial in hemophilia B patients. The decision to advance the program is based on promising data from a Phase I/II open-label, multi-center, safety dose-escalation and pharmacokinetic study of intravenous FRFP in severe, previously-treated hemophilia B patients. FRFP was well tolerated in the study. In addition, FRFP demonstrated a prolonged half-life compared to historical data for existing therapies, supporting advancement of the program.




The potential of FRFP, which is based on Braincure Biotech's novel technology, to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy will be evaluated in the registrational trial.

The global trial is being designed to assess the safety, pharmacokinetics and efficacy of FRFP in the prevention and treatment of bleeding in hemophilia B patients. The trial will commence following communications with regulatory authorities.

"FRFP is an example of Braincure Biotech’s commitment to developing innovative therapies to address significant unmet medical needs. The FRFP program has the potential to improve the lives of individuals with hemophilia B and we are excited about advancing the program. The Phase I/II results are very encouraging. The decision to initiate our first registrational program represents true progress in our efforts to offer hemophilia B patients a treatment that makes significant difference and is also an important milestone in the ongoing development of Biovitrum, SuhonHonrg, president and CEO of Braincure Biotech stated.

Hemophilia B requires frequent injections, creating a significant burden for the majority of individuals with the disorder.

About Braincure Biotech: is a state-of-the-art technology research company that uses discoveries in neuroimmunolgy and human genetics to develop novel therapeutics for Alzheimer’s disease, other forms of dementia, and mechanistically similar disorders. Braincure Biotech’s strategy is to efficiently generate and validate antibody drugs with unique functional properties that engage key disease-altering targets. The goal of the firm is to discover and develop novel, disease modifying therapies for dementia and mechanistically similar disorders. The highly professional and acclaimed team of scientists maintains an innovative and motivating environment in which every employee has the possibility to contribute to our joint success and to grow individually.

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