Gilead and Galapagos discontinuing IPF Phase III front-runner is a major setback in the disease space, says GlobalData

Gilead and Galapagos discontinuing IPF Phase III front-runner is a major setback in the disease space, says GlobalData

Gilead and Galapagos recently announced the discontinuation of the ISABELA Phase III clinical trials investigating ziritaxestat, a once daily autotaxin inhibitor formerly known as GLPG-1690, in patients with idiopathic pulmonary fibrosis (IPF). Due to IPF’s high clinical unmet needs, this discontinuation represents a major setback in the disease space, according to GlobalData, a leading data and analytics company.

Tiffany Chan, Immunology Analyst at GlobalData, explains: “Ziritaxestat was expected to be the next late-state pipeline product to launch and IPF clinical trial design has historically been very difficult for drug manufacturers. Key opinion leaders (KOLs) interviewed by GlobalData note that there are significant challenges in designing appropriate trials, such as selection of patient populations and appropriate endpoints. High prescribing physicians will be closely scrutinizing trial data, which was likely instrumental in the implementation of a Gilead and Galapagos’ IDMC.”

KOLs were initially very optimistic about the design of the ISABELA trials, if successful. However, some did express reservations about the agent’s future, since its Phase II FLORA study only tested 23 patients total. Ziritaxestat was expected to launch in 2023 and garner $557.6m in sales by 2029 in the seven major markets (*7MM). Ziritaxestat’s departure clears the field for Roche’s pamrevlumab, the next pipeline expected to launch and favorite amongst KOLs based on available data.

Chan adds: “Although this is undoubtedly a significant setback both for Gilead and Galapagos, Galapagos does have another pipeline agent in development. In November 2020, Galapagos announced positive topline results for their Phase IIA randomized PINTA study of GLPG1205. However, due to the expected trials needed to gain approval (a Phase IIB dose ranging study and at least two pivotal Phase III studies), it is unlikely that this drug will launch prior to 2029. By the time of its launch, GLPG1205 will have competition from seven marketed agents and two generics, compared to just the two marketed agents ziritaxestat would have joined in 2023.”

*7MM: US, France, Germany, Italy, Spain, UK, and Japan