Topline Results From Four Phase 3 Studies
Gilead Sciences, Inc. (NASDAQ:GILD) announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an investigational, once-daily, fixed-dose combination of sofosbuvir (SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir (VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX; GS-9857), an investigational pangenotypic NS3/4A protease inhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.
In the POLARIS-1 and POLARIS-4 studies, 445 patients with genotype 1-6 HCV infection who were previously treated with direct-acting antiviral agents (DAAs) received 12 weeks of SOF/VEL/VOX. The POLARIS-1 study enrolled patients who failed prior treatment with an NS5A inhibitor. The POLARIS-4 study enrolled patients who failed prior treatment with a DAA that was not an NS5A inhibitor, most with either an NS5B inhibitor alone (73 percent) or an NS5B inhibitor and an NS3/4A protease inhibitor (25 percent).
In the POLARIS-2 and POLARIS-3 studies, 611 patients who were not previously treated with a DAA received 8 weeks of SOF/VEL/VOX. The POLARIS-2 study enrolled patients with genotype 1-6 HCV infection with or without compensated cirrhosis. The POLARIS-3 study enrolled patients with genotype 3 HCV infection, all of whom had compensated cirrhosis.
The primary endpoint for all studies was SVR12. The intent-to-treat SVR12 rates observed in the POLARIS studies are summarized in the following table. Complete results from all four studies will be presented at The Liver Meeting® 2016 in Boston.
Patients treated with SOF/VEL/VOX for 12 or eight weeks had similar overall incidence of adverse events compared to placebo-treated or SOF/VEL-treated patients. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. Among the 1,056 patients who received SOF/VEL/VOX in the four studies, one patient (less than one percent) receiving SOF/VEL/VOX for 12 weeks discontinued due to an adverse event.
“Despite recent advances that have provided high cure rates and simplified treatment for most HCV patients, those who have failed previous treatment with direct acting antivirals continue to represent an unmet medical need. The POLARIS study results demonstrate that combining three potent antivirals with different mechanisms of action and high barriers to resistance can provide high cure rates for patients who have failed other highly effective oral DAA regimens,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Based on these Phase 3 results, we plan to submit regulatory applications for SOF/VEL/VOX for the treatment of chronic HCV in the United States in the fourth quarter of 2016 and shortly thereafter in Europe.” (Original Source)
Top-Line Phase 2 Results for GS-4997
In addition, Gilead announced the top-line results from three Phase 2 studies of GS-4997 (selonsertib), an investigational inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in nonalcoholic steatohepatitis (NASH), pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). GS-4997 demonstrated anti-fibrotic activity in an open-label Phase 2 clinical trial that included 72 patients with NASH and moderate to severe (F2-F3) liver fibrosis, who received treatment with GS-4997 (18 mg or 6 mg orally once daily) alone or in combination with simtuzumab (SIM), an investigational antibody directed against lysyl oxidase-like-2 (LOXL2), or SIM alone (125 mg administered via weekly subcutaneous injections) for 24 weeks. Top-line efficacy data for fibrosis-related endpoints from 67 evaluable patients are summarized in the table below. Complete results will be presented at The Liver Meeting® 2016 in Boston.
Overall, GS-4997 was well tolerated with no dose-related increase in the incidence of treatment-emergent adverse events or serious adverse events. The most common adverse events were headache, nausea and sinusitis.
“We are committed to advancing our pipeline of investigational molecules that separately target metabolic dysfunction, inflammation and/or fibrosis associated with NASH,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We are encouraged by these data demonstrating the anti-fibrotic effect of GS-4997 in patients with NASH after only 24 weeks of treatment, and look forward to sharing the complete results with the hepatology community. Additionally, pending discussions with regulatory agencies, we plan to initiate a Phase 3 clinical trial program of GS-4997 in patients with NASH.”
Separately, a Phase 2 study of GS-4997 in PAH did not achieve its primary endpoint and a Phase 2 study in DKD did not achieve its primary endpoint based on a preliminary analysis. Due to insufficient evidence of efficacy, Gilead has decided not to pursue Phase 3 studies of GS-4997 in PAH or DKD at this time. Data from these studies will be submitted for presentation at upcoming scientific conferences. (Original Source)
Shares of Gilead are currently trading at $73.86, up $0.52 or 0.71%. GILD has a 1-year high of $111.11 and a 1-year low of $72.21. The stock’s 50-day moving average is $77.34 and its 200-day moving average is $83.38.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report issued on October 18, Robert W. Baird analyst Brian Skorney reiterated a Buy rating on GILD, with a price target of $100, which represents a potential upside of 36.7% from where the stock is currently trading. Separately, on October 14, Cowen’s Phil Nadeau reiterated a Buy rating on the stock and has a price target of $120.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Skorney and Phil Nadeau have a total average return of 20.9% and 6.1% respectively. Skorney has a success rate of 55% and is ranked #81 out of 4180 analysts, while Nadeau has a success rate of 51% and is ranked #577.
The street is mostly Bullish on GILD stock. Out of 17 analysts who cover the stock, 9 suggest a Buy rating and 8 recommend to Hold the stock. The 12-month average price target assigned to the stock is $103.71, which implies an upside of 42% from current levels.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Its primary areas of focus include primary areas of focus include human immunodeficiency virus (HIV), liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, oncology and inflammation, and serious cardiovascular and respiratory conditions.