Vaderis Therapeutics AG

Vaderis' VAD044 Receives FDA Fast Track Designation for Hereditary Hemorrhagic Telangiectasia

6 months ago

• Vaderis Therapeutics' VAD044, an allosteric AKT-inhibitor, has been granted Fast Track designation by the FDA for treating Hereditary Hemorrhagic Telangiectasia (HHT). • The FDA's Fast Track program aims to accelerate the development and review of drugs addressing serious conditions with unmet medical needs, potentially expediting VAD044's availability. • VAD044 is an oral, once-daily therapy and the first novel treatment specifically designed for HHT, a genetic bleeding disorder lacking approved treatments. • HHT is a rare, inherited bleeding disorder that causes significant disease burden, reduced life expectancy, and impaired quality of life, highlighting the need for effective therapies.

Vaderis' VAD044 Shows Promise in Hereditary Hemorrhagic Telangiectasia Trial

9 months ago

• Vaderis Therapeutics' VAD044 demonstrated favorable safety and tolerability in a Phase 2 proof-of-concept trial for Hereditary Hemorrhagic Telangiectasia (HHT). • The trial showed clinically meaningful improvements in epistaxis frequency, duration, and epistaxis-free days in HHT patients treated with VAD044. • Interim data from an open-label extension study indicate continued improvements in bleeding parameters with sustained VAD044 treatment over six months. • Vaderis is engaging with health authorities to advance VAD044 into pivotal phase development for HHT, a disease with no approved treatments.