Gilead Touts Promising Data for HCV, NASH Drug Candidates

Gilead Sciences announced new study results on Thursday for two experimental therapies.

SOF/VEL/VOX

First, the biotech company based in Foster City, California said a triple combination treatment for hepatitis C (HCV) had shown high cure rates for all six genotypes of the virus, reported Reuters.

Investigators in charge of four Phase 3 trials tested Sovaldi in combination with antiviral medications velpatasvir and voxilaprevir on a diverse mix of patients. Volunteers varied between previously untreated patients or those who failed prior therapy as well as individuals with and without advanced liver damage from cirrhosis.

All four trial results indicated this combination achieved cure rates ranging between 95 and 97 percent at the end of either eight or 12 weeks of treatment by using different mechanisms to prevent the virus from replicating in the patient’s blood, explained Reuters.

GS-4997

Next, the firm announced mixed results for GS-4997 (Selonsertib), an investigational therapy being tested for a variety of ailments.

A preliminary analysis indicated GS-4997 failed to meet primary endpoints evaluating its efficacy in treating pulmonary arterial hypertension and diabetic kidney disease in two Phase 2 studies.

Gilead didn’t provide detailed data as to why or how GS-4997 didn’t hit its intended goal, but the drug fared well in an open-label Phase 2 clinical trial featuring 72 patients diagnosed with nonalcoholic steatohepatitis (NASH) and moderate to severe liver fibrosis.

Participants took three different dosing regimens over a 24 week period, according to FierceBiotech.

About 43 percent of patients taking the 18 milligrams of GS-4997 in conjunction with an anti-fibrotic drug called simtuzumab, which lead to an estimated one-stage improvement in fibrosis. Participants who took 6 milligrams of this compound with simtuzumab experienced a 30 percent improvement.

Overall, the drug was well tolerated with no dose-related increase of adverse events although some volunteers experienced minor symptoms like headaches and nausea, per the company’s announcement.

Next Steps

Gilead will unveil comprehensive data at the Liver Meeting in Boston next month as it preps for a Phase 3 trial clinical trial further evaluating the drug’s efficacy in treating NASH.

Furthermore, the company will file regulatory submissions for SOF/VEL/VOX to be considered a chronic HCV treatment in the U.S. and Europe by the end of 2016.

Allergan is another company that has been particularly active in this space. It recently acquired a number of companies specializing in therapies for NASH and similar diseases.Thompson Reuters published an analysis earlier this year noting the liver disease treatment could yield more than $1 billion in sales for biotech companies.