The agreement will allow Gilead to have access to Galapagos’ therapeutic platform, which includes six molecules currently in clinical trials, and more than 20 investigational therapies.
“We are excited to enter into this unique agreement, which will generate both long-term strategic value and mutual, immediate benefits. We chose to partner with Galapagos because of its pioneering target and drug discovery platform, proven scientific capabilities and outstanding team,” Daniel O’Day, Gilead’s chairman and CEO, said in a press release.
“Gilead also gains exclusive access to all current and future compounds in Galapagos’ rich pipeline, while Galapagos is able to expand its research activities and build commercial infrastructure. The collaboration reflects Gilead’s intent to grow our innovation network through diverse and creative partnerships,” O’Day added.
GLPG1690 inhibits GPR84, a pro-inflammatory protein that promotes chronic inflammation in IPF. It was granted orphan drug designation by the U.S. Food and Drug Administration in June 2017, and by the European Commission in September 2016 as a treatment for IPF.
The Phase 3 program includes two identically designed trials, called ISABELA 1 (NCT03711162) and ISABELA 2 (NCT03733444). The trials are expected to enroll a total of 1,500 patients, ages 40 years or older, who have received an IPF diagnosis within five years of trial initiation. The trials will take place at more than 200 clinical sites worldwide, including at locations in the U.S, and Europe.
During the studies, participants will be randomly selected to receive one of two doses of GLPG1690 or a placebo, in addition to their IPF standard-of-care treatment. Those enrolled will continue the assigned treatment until the last patient in each of the studies has completed 52 weeks of treatment. This means that some participants will be followed for substantially more time than the minimum of 52 weeks (one year).
The trials will allow researchers to identify potential treatment-related adverse events that occur less frequently, and could be difficult to detect with fixed one-year studies.
Researchers will assess GLPG1690’s efficacy in improving participants’ lung function compared with placebo. Its effectiveness will be determined by the rate of decline in forced vital capacity (FVC), which is the amount of air a person can forcefully and quickly exhale after taking a deep breath. They also will evaluate changes in disease progression, frequency of respiratory-related hospitalizations, quality of life, and mortality.
Under the agreement, Galapagos will receive a $3.95 billion upfront payment, and a $1.1 billion equity investment from Gilead. Galapagos will use the proceeds to expand and accelerate its research and development programs.
“What a fantastic moment in our 20th anniversary year to sign this landmark deal with our great partner Gilead,” said Onno van de Stolpe, CEO of Galapagos.
“Galapagos has been highly effective at target identification and drug discovery, progressing novel molecules from research into the clinic. We will benefit greatly from Gilead’s expertise and infrastructure and believe this collaboration will provide an accelerated path to advance our pipeline. With the capital provided by Gilead, we aim to progress innovation to patients,” van de Stolpe said.