DS Biopharma launches liver drug spin-out

Ireland’s DS Biopharma has launched a spin-out company to develop a drug for non-alcoholic steatohepatitis (NASH) – a disease for which there are no approved drugs that has attracted the attention of companies such as Gilead and Intercept.

The new company, Afimmune, will also focus on pulmonary disorders such as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

Afimmune will continue development of DS102, a novel anti-fibrotic compound in NASH as well as certain pulmonary disorders. It has other compounds in pre-clinical development.

NASH is a serious chronic liver disease, which resembles alcoholic liver disease, but in people who drink little or no alcohol.

Afimmune plans to start a phase 2a study with DS102 in NASH patients later this year, after a phase 1 trial showed it was safe and well tolerated.

The company plans a phase 2a trial in COPD patients following positive pre-clinical data.

Meanwhile, DS Biopharma will develop DS107, an anti-inflammatory compound for atopic dermatitis and pruritus, and DS109 for other inflammatory skin disorders such as acne.

In April, Gilead bought a subsidiary of Nimbus Therapeutics, which is developing an early-stage NASH drug, for $1.2 billion.

Gilead’s decision was surprising given that Intercept Pharmaceuticals has a NASH drug, obeticholic acid, in phase 3 development for NASH.

Under the brand name Ocaliva, obeticholic acid has already been approved earlier this year in the US for another liver disease, primary biliary cholangitis.

And earlier this month, the US Food and Drug Administration granted a fast track designation for Shire’s volixibat, meaning the regulator will help expedite development.

Shire will begin a phase 2 trial of the drug in the US, Canada and the UK.

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