The FINANCIAL — Gilead Sciences, Inc. on October 21 confirmed that the company fulfilled a request for compassionate access to GS-5734, a novel nucleotide analogue in development for the potential treatment of Ebola Virus Disease (EVD). The request was received last week and drug was shipped later the same day. The compound is currently being provided to a female patient in the United Kingdom, as described earlier today by officials from the Royal Free Hospital in London.
“It is very encouraging to hear that the patient in question is doing better and is no longer in critical condition. Our thoughts and wishes for continued recovery are with her, with her family and the excellent medical team at Royal Free Hospital,” commented Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We recognize the urgent need for treatments to address Ebola and we are working with collaborators to advance development of GS-5734 as quickly as possible.”
GS-5734 was discovered as part of Gilead’s program to screen compounds in its libraries for activity against a range of potential emerging viruses, including Ebola. In collaboration with the Centers for Disease Control and Prevention (CDC) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the company identified GS-5734 in vitro activity against the Ebola virus, according to Gilead.
In animal studies conducted at USAMRIID, treatment initiated on day 3 post-infection with Ebola virus resulted in 100 percent survival of monkeys. Data from these studies were recently presented at the annual Interscience Conference of Antimicrobial Agents and Chemotherapy / International Congress of Chemotherapy and Infection (ICAAC/ICC) meeting and at ID Week. Gilead recently initiated a Phase 1 clinical trial in healthy human volunteers to determine the safety, tolerability and pharmacokinetics of GS-5734.
Ebola represents a global public health crisis, and Gilead is working with USAMRIID and a number of private and public health entities to determine next steps on how to advance evaluation of GS-5734. In the event that the compound proves to be safe and effective in humans, Gilead plans to work to enable access as broadly and quickly as possible. In the interim, the company will review any requests for compassionate access on a case by case basis.
GS-5734 is an investigational compound that has not been proven safe and effective for EVD; additionally, its clinical effect in this particular patient case cannot be determined.