Bluejay hatches $182m funding egg for hepatitis drugs

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Wouter

Bluejay Therapeutics has completed a sizeable third-round financing, raising $182 million that will be used for clinical trials of its drug candidates for hepatitis.

The proceeds are earmarked mainly for trials of BJT-778, its lead candidate for chronic hepatitis D virus (HDV) infections, but will also support earlier-stage hepatitis B virus (HBV) projects, according to the California-based biotech.

HDV is a virus that exists only as a co-infection with HBV and is seen in around 5% of the estimated 257 million people around the world with chronic hepatitis B, equivalent to around 12 million cases. Like HBV, HDV is most commonly transmitted from mother to child during birth, and through contact with blood or other body fluids, for example, through sex with an infected partner or the sharing of syringes.

Numbers have declined in recent years because of HBV vaccination programmes, but there are still hotspots around the world, including Mongolia, the Republic of Moldova, and some countries in western and central Africa. Infection is also serious, as having both HBV and HDV increases the risk of liver disease-related death and liver cancer, and mortality rates can be as high as 50% within five years.

At the moment, the only drug approved to treat HDV is Gilead Sciences’ Hepcludex (bulevirtide), which has been available in Europe since 2020 as well as other areas of the world but was rejected by the US FDA in 2022.

BJT-778 is a monoclonal antibody targeting the hepatitis B surface antigen (HBsAg) that is being developed for both HDV and HBV and in March was awarded Priority Medicine (PRIME) status by the EMA. It acts as an anti-viral to HDV by neutralising and facilitating the clearance of HDV virus particles.

Bluejay recently reported that it had completed a phase 1a trial of the drug involving healthy volunteers, saying it showed “excellent safety and tolerability,” and had enrolled all the subjects in a phase 1b study in people with chronic HDV and HBV infections.

Its clinical-stage pipeline also includes cavrotolimod, a TLR9 agonist licensed from Exicure in February for development as an HBV therapy.

The round was co-led by Frazier Life Sciences and an unnamed institutional investor, with buy-in from both new and existing investors, including RA Capital Management, T Rowe Price, Wellington Management, Novo Holdings, RiverVest Venture Partners, Octagon Capital, Arkin Bio Ventures, HBM Healthcare Investments and Unicorn Capital. It follows a $41 million Series B that closed in 2022.

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