Good and bad news for Gilead
- Selonsertib, a drug from HIV and Hep C-focused company Gilead Sciences, has missed the primary endpoint in its phase 2 trials for pulmonary arterial hypertension and diabetic kidney disease, prompting the company to nix Phase 3 studies for these indications.
- In nonalcoholic steatohepatitis (NASH), selonsertib at the highest dose, alone or in combination with simtuzumab, reduced the development of fibrosis in 43% of the patients compared with 20% of patients treated with simtuzumab. While positive, this data comes from only 67 evaluable patients, with no placebo control, and will likely need to be backed up with more robust data.
- Gilead plans to discuss Phase 3 with the Food and Drug Administration, though it's not clear whether these will be monotherapy or combination therapy. The company's stock moved upwards slightly on the news, but has fallen more than 25% fall over the last six months.
The curative drugs for hepatitis C have caused a revolution for patients and physicians, but have actually created a conundrum for the companies developing the drugs. What to do when everyone is cured?
As Gilead's marketed drugs portfolio, including Harvoni and Solvadi, is highly reliant on hepatitis C, this could mean a challenging time ahead for the big biotech.
NASH, a liver disease associated with obesity, is a possible step in the right direction. This is a growing market and one that currently has no treatment options. Gilead has four candidates in its pipeline currently in Phase 1 and Phase 2 trials, including simtuzumab and selonsertib.
However, analysts from Jefferies question the impact of the monoclonal antibody simtuzumab, suggesting that Phase 2 results may not boost the chance of success for the antibody.
Other companies are moving into the NASH market, and competition for the 5 million patient population could quickly grow. Allergan has recently bought up two biotechs with NASH drugs in their pipelines. Cempra's antibiotic solithromycin is in a small Phase 2 trial, and showing reductions in a NASH biomarker. And newly-created Afimmune is plotting a Phase 2a for this year.
While Gilead's pipeline also includes candidates in cancer, cardiovascular disease and inflammation, it's hard to see the near-term blockbuster the company needs amongst them. Investors and analysts are hoping the company will tap into its large warchest to acquire good late-stage or revenue-generating marketed drugs, perhaps involving a change of therapeutic direction.
- Gilead Sciences Statement
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