Clinical Trials

Clinical-stage biotech company Rallybio Corporation has announced that it has received approval from two regulatory bodies for its clinical trial applications (CTAs) for a phase 2 study involving pregnant women.

Both the European Medicines Agency (EMA) and UK Medicines and Healthcare products Agency (MHRA) approved the CTAs for Rallybio’s RLYB212 treatment, which aims to aid pregnant women at higher risk of HPA-1A alloimmunosation and foetal and neonatal alloimmune thrombocy topenia (FNAIT). FNAIT causes uncontrolled bleeding in foetuses and newborns and is potentially life-threatening, but currently has no approved therapy for its prevention nor prenatal treatment. It is caused by an immune incompataiblity between mother and foetus in the human platelet antigen 1 (HPA-1).

The study will take place across the Netherlands, Belgium, Norway, Sweden and the UK and aims to assess the pharmacokinetics and safety of RLYB212 – a monoclonal anti-HPI-1 antibody.

Stephen Uden MD, CEO of Rallybio commented, “Securing these CTA approvals from European health authorities to advance RLYB212 into a phase 2 trial is a significant achievement. These approva ls are a testament to the dedication and innovation of our team and our partners as we advance this first ever programme to prevent maternal alloimmunisation and FNAIT… We are activating clinical sites and expect to initiate screening this quarter, which will mark another important step toward achieving our mission to prevent FNAIT and its potentially devastating consequences.”