NASH failed trials

On February 11, Gilead Sciences (GILD) issued a press release announcing the top line results from its Phase 3 STELLAR-4 study evaluating the investigational oral therapy selonsertib in the treatment of NASH (nonalcoholic steatohepatitis) patients suffering from F4 compensated cirrhosis. On April 25, the company issued a press release announcing the top line results from its Phase 3 STELLAR-3 study evaluating selonsertib in the treatment of NASH patients with F3 bridging fibrosis. The drug failed to meet its prespecified primary endpoints in both trials.

Gilead Sciences hasn’t changed its SG&A (selling, general, and administrative) and R&D (research and development) expense guidance for 2019, but it plans to update them if required during its second-quarter earnings call. In its first-quarter earnings investor presentation, the company reaffirmed its 2019 SG&A expense guidance of $3.90 billion–$4.10 billion and its R&D expense guidance of $3.60 billion–$3.80 billion. The company expects to save on SG&A expenses that would have been required to support commercial launch activities for selonsertib. In the absence of such spending, the company expects to invest some of these funds in improving the launch readiness of its investigational rheumatoid arthritis therapy, filgotinib.

How Is Gilead Sciences Revamping Its NASH Strategy in 2019?

NASH strategy

Gilead Sciences is currently evaluating its investigational compounds selonsertib, firsocostat, and cilofexor in various combinations in the treatment of patients suffering from bridging fibrosis or compensated cirrhosis due to NASH in its Phase 2 ATLAS trial. According to its first-quarter earnings conference call, the company expects to release data from this trial in the fourth quarter of 2019.

As Gilead pointed out on its first quarter earnings conference call, it presented more than 35 abstracts related to NASH, primary sclerosing cholangitis, and viral hepatitis at the International Liver Congress in Vienna in April 2019. The company presented novel data to highlight the potential in evaluating combination therapies for NASH as well as the noninvasive diagnostic test for the disease.

On April 12, Gilead Sciences issued a press release announcing its intent to commence collaboration with Novo Nordisk (NVO) for the development of combination regimens targeting NASH. The companies plan to initiate a proof-of-concept study evaluating the combination of Gilead Sciences’ FXR agonist, cilofexor, and ACC inhibitor, firsocostat, with Novo Nordisk’s GLP-1 analogue, semaglutide, in NASH indications.

On April 16, Gilead Sciences issued a press release announcing a three-year collaboration with insitro to leverage insitro’s proprietary platform for the discovery of novel drug targets in NASH indications.

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