Gilead Sciences’ (GILD) and Galapagos’ (GLPG) product filgotinib – a highly selective JAK1 inhibitor has met the primary efficacy endpoint in Phase 2 TORTUGA trial in adults with moderately to severely active ankylosing spondylitis (AS). Patients treated with filgotinib achieved significantly greater improvements compared to those who took a placebo.
The results came from the Phase 2 of the TORTUGA – a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study. The trial goal is to assess the safety and efficacy of filgotinib in adult patients with moderately to severely active AS. The trial was conducted in Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain, and Ukraine. on 116 patients randomized in a 1:1 ratio to receive filgotinib 200 mg or placebo once daily for 12 weeks.
The primary objective of TORTUGA was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of AS at Week 12 by ASDAS (a standard composite index for assessing AS, which incorporates five disease activity variables).
According to the firms’ press release, the adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups. Laboratory changes demonstrated consistency with previously reported laboratory results from filgotinib with no new safety signals observed.
Serious adverse events were reported for a patient receiving filgotinib who experienced pneumonia and recovered after hospital-based antibiotic treatment. One patient randomized to filgotinib, with an inherited risk for thrombosis, experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, opportunistic infections or cases of Herpes zoster were observed in the study.
More detailed results from the TORTUGA trial will be submitted for presentation at a future scientific conference.
Ankylosing Spondylitis is a systemic, chronic, and progressive sero-negative spondyloarthritis that affects the spine and sacroiliac (SI) joints and may progress to spinal fusion, leading to permanent disability.
Currently, there is no known cure for AS, but there are treatments and medications available to reduce signs and symptoms and manage pain.
If you don’t yet know Galapagos, it is a clinical-stage biotechnology specialized in the discovery and development of new entity small molecule drugs to improve the treatments of many diseases that are in need for improvement. Galapagos pipeline comprises programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis, idiopathic pulmonary fibrosis, and atopic dermatitis – all are serious and important diseases with some that have yet to find treatments.
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The Phase 2 TORTUGA trial for ankylosing spondylitis described above is one of many Phase 2 trials conducted by Galapagos for inflammatory diseases.
The clinical trials include the ongoing FINCH Phase 3 program for rheumatoid arthritis, the DIVERSITY Phase 3 trial for Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.
Galapagos in the Stock Market
On Sept. 6, 2018, Galapagos stock was trading at $93.10 with a market cap is $4.70 billion. The stock’s 52-week high is $121.9 and its 52-week low is $84.13, which means that the current stock price in near the 52-week price low.
As you might have observed, the diseases Galapagos is trying to treat are mostly inflammatory and autoimmune diseases. Many of these diseases require better treatments and some have yet to find treatments. All have huge markets.
With regard to Gilead, the uncharted territory it is trying to explore with Galapagos is important and promising especially as the collaborator is Galapagos. Ankylosing Spondylitis has promising results and Crohn’s Disease, Ulcerative Colitis and other autoimmune diseases still have big unmet needs
The irony is that, with yesterday’s good news about Ankylosing Spondylitis, both firms’ stocks have plummeted.
C’est la Vie.
That’s how a French friend commented on the stocks’ decline following good news.