In February, Galapagos NV Chief Executive Officer Onno van de Stolpe promised that 2019 will be a “data rich year” for the Belgium-based company and its lead product, filgotinib.
In February, Galapagos NV Chief Executive Officer Onno van de Stolpe promised that 2019 will be a “data rich year” for the Belgium-based company and its lead product, filgotinib.
During a presentation of year-end results for 2018, van de Stolpe said 2018 was “truly pivotal in the history” of the company due to the publication of its first-ever Phase III results from the FINCH 2 trial in rheumatoid arthritis. Galapagos and Gilead teamed up to investigate filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents. Additionally, the company reported promising results of its filgotinib product in mid-stage trials for ankylosing spondylitis (AS) and psoriatic arthritis. With the first quarter of 2019 closing in, Galapagos is expecting additional late-stage results from its FINCH 1 and FINCH 3 trials, which are exploring the safety and efficacy of filgotinib in other RA patients.
With data expected for the FINCH 1 and FINCH 3 trials by the end of March, investors are hoping that the results will mean a potential shot at cutting into AbbVie’s dominance of the RA market with its blockbuster Humira. Cory Renauer, an analyst writing in the Motley Fool, said many RA patients are hoping for an effective treatment that is not an injection, such as Humira. JAK inhibitors have been seen as a potential answer to that, but there have been some issues with blood clots associated with the medication, Renauer said. While investors are anxiously awaiting for Galapagos’ JAK data, Renauer noted that AbbVie is hard at work on its own JAK inhibitor product, upadacitinib. In February, AbbVie announced the FDA accepted for priority review its New Drug Application (NDA) for upadacitinib, a JAK inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. AbbVie said it anticipates a regulatory decision in the third quarter of 2019. If Galapagos and Gilead post positive results from FINCH 1 and FINCH 3, Renauer said it might be worth it to investors to have a few shares in their portfolio as they will likely go up.
Another company that Renauer noted is eagerly awaiting some late-stage clinical results this quarter is New York-based Axsome Therapeutics. The company is developing a treatment for major depressive disorder known as AXS-05, a novel, oral, glutamatergic and monoaminergic investigational medicine consisting of dextromethorphan and bupropion – a cough suppressant and common anti-depressant. In January, the company announced AXS-05 hit the mark in a Phase II trial for MDD. The company said that after six weeks of treatment with AXS-05, 47 percent of patients achieved remission in their MDD compares to 16 percent of patients who received bupropion alone. If the company’s treatment keeps impressing in the clinic, Renauer said that AXS-05 will have the potential to sway some prescribers who might opt for J&J’s recently approved esketamine-based MDD treatment to instead choose the Axsome product. Axsome is expecting another readout involving AXS-05 later this year,
