Vaderis Therapeutics has closed an oversubscribed $152 million Series B financing and initiated its global Phase 3 HEROIC study evaluating engasertib in patients with hereditary hemorrhagic telangiectasia. The private financing was co-led by Life Sciences at Goldman Sachs Alternatives and TCGX, with participation from Omega Funds, EQT Life Sciences, Perceptive Advisors and Kalehua Capital, along with existing investors Medicxi and Droia.
The financing is expected to provide Vaderis with capital to fund planned operations through regulatory submissions and potential U.S. regulatory approval of engasertib.
Engasertib, also known as VAD044, is an investigational once-daily oral selective allosteric AKT1/2 inhibitor being developed for hereditary hemorrhagic telangiectasia, or HHT.
HHT is a rare genetic vascular disorder characterized by recurrent bleeding and arteriovenous malformations. Vaderis said there are currently no approved therapies specifically for the disease anywhere in the world.
The financing and Phase 3 launch follow publication of proof-of-concept and long-term extension data in The New England Journal of Medicine that Vaderis said showed clinically meaningful and sustained improvements across multiple disease measures.
HEROIC is a global randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of once-daily engasertib in patients with moderate-to-severe HHT.
The study is expected to enroll patients at sites across North America, South America and Europe.
Vaderis estimates HHT affects approximately one in 3,800 people. Engasertib has not been approved in any country for any indication.
KEY QUOTES:
“Closing this financing and initiating HEROIC as the first Phase 3 study utilizing a molecule specifically developed for HHT marks an exciting new chapter.”
“This milestone reflects the dedication of our patients, investigators, study teams, and advocacy organizations, to whom we extend our deepest gratitude.”
Azmi Nabulsi, M.D., MPH, President and Chief Executive Officer of Vaderis Therapeutics
“Vaderis has generated compelling clinical evidence supporting targeted AKT inhibition as a novel treatment approach for HHT.”
Colin Walsh, Ph.D., Managing Director, Life Sciences at Goldman Sachs Alternatives
