New Haven-based Rallybio announced on Thursday the launch of a Phase 1 clinical trial for its latest drug candidate to fight a rare disease in newborns and outlined its goals for the coming year.
The company reported that the first subjects have been dosed in its study of RLYB212, a novel human monoclonal antibody drug candidate designed to prevent fetal and neonatal alloimmune thrombocytopenia (FNAIT).
FNAIT is a life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns.
In December Rallybio announced positive data from a Phase 1/2 study of its RLYB211 for the same ailment, with results showing significant benefit over a placebo.
Rallybio’s plans for 2022 include launching a study of its RLYB116, a potential treatment for patients with paroxysmal nocturnal hemoglobinuria and generalized Myasthenia Gravis.
Also on tap are studies later of a slate of drug candidates for the treatment of hypophosphatasia, a metabolic disorder. That work is in partnership with U.K.-based biotech Exscientia, which utilizes artificial intelligence in drug discovery.
Rallybio CEO Martin Mackay said, “Our mission is to build Rallybio into a leading biotechnology company, with a broad and sustainable pipeline of product candidates that can transform the lives of people with severe and rare disorders and shatter expectations of what’s possible.”
Rallybio, a startup founded by three former Alexion executives, launched in January 2018 and has built a portfolio of candidates to treat rare diseases in the areas of hematology, immuno-inflammation, maternal fetal health and metabolic disorders.
Rallybio’s IPO in August brought in nearly $93 million, with shares debuting at $13 each. Shares were trading around $9 this week.
Contact Liese Klein at lklein@newhavenbiz.com.
