FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group (OR 1.65 [95% CI 1.09-2.48]; p=0.017). The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”
Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. Outside of Japan, remdesivir is an investigational, unapproved drug. The U.S. Food and Drug Administration (FDA) granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19; the authorization is temporary and does not take the place of the formal new drug application submission, review and approval process.
In this study, hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for 5 or 10 days or standard of care alone. The primary endpoint was the clinical status as assessed by a 7-point ordinal score at Day 11, ranging from hospital discharge to increasing levels of oxygen and ventilatory support to death. The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.
At Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard of care group, achieving statistical significance for a ≥ 1-point improvement in ordinal scale (p=0.026). In addition, non-statistically significant increases in clinical worsening or death were observed in the standard of care only group compared with the remdesivir groups.
“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results. The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes. Our SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies and the development of alternate formulations.”
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 5 percent of patients in both treatment groups were nausea (5-day: 10% / 10-day: 9% / SOC: 3%), diarrhea (5-day: 5% / 10-day: 5% / SOC: 7%) and headache (5-day: 5% / 10-day: 5% / SOC: 3%).
Key efficacy and safety results from the study are included in the table below.
|
|
5-Day RDV |
10-Day RDV |
SOC |
|
Clinical Efficacy Outcomes at Day 11 |
|||
|
≥ 2-point improvement in ordinal scale |
134 (70) |
126 (65) |
121 (61) |
|
≥ 1-point improvement in ordinal scale |
146 (76) |
135 (70) |
132 (66) |
|
Requiring any oxygen support |
12 (6) |
13 (7) |
22 (11) |
|
≥ 1-point worsening in ordinal scale |
6 (3) |
12 (6) |
22 (11) |
|
Death |
0 |
2 (1) |
4 (2) |
|
Safety |
|||
|
Any adverse event (AE) |
97 (51) |
106 (55) |
90 (45) |
|
Grade ≥3 AE |
20 (10) |
21 (11) |
24 (12) |
|
Any serious adverse event (SAE) |
8 (4) |
7 (4) |
18 (9) |
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with a high prevalence of COVID-19 infections. The studies were conducted at more than 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive either a 5-day or a 10-day treatment course of remdesivir in addition to standard of care. Topline results were announced on April 29 and the full data were published in The New England Journal of Medicine on May 27. An expansion phase of the study was added to enroll up to 5,600 additional patients, including those on mechanical ventilation.
The second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with moderate manifestations of COVID-19, compared with standard of care. The initial phase of the study randomized 600 patients in a 1:1:1 ratio to receive either a 5-day or a 10-day treatment course of remdesivir in addition to standard of care, compared with standard of care alone. An expansion phase of the study was added to enroll up to 1,000 additional patients with moderate disease. The initial study results are announced in this press release, and results from the expansion phase are expected in the coming months.
Important Information about Remdesivir in the United States
Remdesivir (GS-5734™) is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. SARS-CoV-2 is the coronavirus that causes COVID-19 disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate, as remdesivir must be administered intravenously.
Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19. This use of remdesivir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The FDA Letter of Authorization for the EUA is available at www.gilead.com/remdesivir.
There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use. Warnings: In clinical studies with remdesivir, infusion-related reactions and liver transaminase elevations have been observed. Remdesivir should not be used in patients who are hypersensitive to any ingredient of remdesivir. If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally, monitor serum chemistries and hematology daily during therapy. The decision to continue or discontinue remdesivir therapy after development of an adverse event should be made based on the clinical risk benefit assessment for the individual patient.
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during remdesivir treatment and considered to be potentially attributable to remdesivir. These events must be reported within 7 calendar days from the onset of the event. MedWatch adverse event reports can be submitted to FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
This is not all of the important information for remdesivir. The FDA has authorized distribution of this medicine with accompanying Fact Sheets, which can be accessed at www.gilead.com/remdesivir. Healthcare providers should review the Fact Sheet for Healthcare Providers for more information on the authorized use of remdesivir and mandatory requirements of the EUA.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. Remdesivir is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if remdesivir is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information about the emergency use of remdesivir in the United States, please see the Emergency Use Authorization Fact Sheets available at www.gilead.com/remdesivir.
GS-5734, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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