Pharmaceutical Business review

Gilead stops phase 2 study of simtuzumab for treatment of idiopathic pulmonary fibrosis

The study’s data monitoring committee (DMC) recommended for termination of the trial early because of lack of efficacy.

Gilead is however continuing the phase 2 trials of the investigational monoclonal simtuzumab in patients with nonalcoholic steatohepatitis and primary sclerosing cholangitis.

The company’s decision follows the DMC’s recommendation to continue the studies, which have a 96-week endpoint.

Gilead purchased simtuzumab from Arresto Biosciences in January 2011 for $225m.

Simtuzumab is highly selective for lysyl oxidase-like-2 (LOXL2), an enzyme which promotes the cross-linking of collagen fibers by changing the extracellular matrix.

Separately, Gilead said two phase 3 clinical trials evaluating tenofovir alafenamide (TAF) as a hepatitis treatment met their primary objectives.

The studies demonstrated that TAF was non-inferior to Gilead’s Viread (tenofovir disoproxil fumarate, TDF) depending on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy.

TAF has also demonstrated improved renal and bone laboratory safety parameters compared to Viread.

Based on the results, the company plans US and European regulatory filings in the first quarter of this year.