Promethera Biosciences has raised €39.7 million ($44.4 million) to put its liver disease cell therapy through clinical trials.

Promethera Biosciences has raised €39.7 million ($44.4 million) to put its liver disease cell therapy through clinical trials. The series D round comes as Promethera prepares to start testing its lead drug in end-stage NASH patients.

Belgian biotech Promethera’s pipeline is centered on HepaStem, an allogeneic cell therapy based on liver-derived progenitor cells. Promethera is set to finish a phase 2a of the drug in acute-on-chronic liver failure (ACLF) in the summer, setting it up to start further studies and embark on the next stage of its evolution.

A 200-plus patient ACLF trial is due to start in Europe by the end of the year. That will be the biggest test of HepaStem to date but in the longer-term ACLF may prove to be a stepping stone to a larger opportunity.

“ACLF was a bit of a gateway indication as in NASH we’ll focus on end-stage, pre-cirrhotic/cirrhotic patients,” Promethera CEO John Tchelingerian said. “NASH is becoming really big for us.”

Promethera originally planned to move swiftly into NASH, setting a target of getting into the clinic in 2017. But it subsequently switched gears and pushed back its plans as part of a decision about how to position HepaStem in the competitive NASH field.

Promethera is targeting patients with F4 and end-stage F3 NASH, advanced forms of the disease against which its rivals are yet to generate strong late-phase data. Intercept Pharmaceuticals began testing Ocaliva in F4 patients last year.

Tchelingerian said the NASH trial will definitely start in 2019, initially in Europe. Later, Promethera plans to expand NASH clinical development into the U.S. and Asia, specifically Japan, a country that is playing a big role in its progress.

New Japanese investors ITOCHU, which contributed €10 million, and Shinsei Capital Partners led the series D with the support of other Asian financiers. The predominance of Japanese investors is the result of a concerted effort by Promethera, which began focusing on the country after Tchelingerian’s appointment in 2015 and now has a five-person office in Tokyo.

“Asia is a sweet spot for us. They’re very savvy about regenerative  medicine. They understand well our cell therapies. Liver disorders are huge problems in Asia,” Tchelingerian said. “We’re entertaining discussions with Japanese pharma for potential partnerships in the future.”

Source. FierceBioTech,  Nick Paul Taylor, May 9, 2019

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