GALAPAGOS NV/S ADR (NASDAQ:GLPG) recently announced that it has dosed its first patient in the worldwide ISABELA Phase 3 program with autotaxin inhibitor GLPG1690 in IPF. Shares of the stock are fighting to hold key trendline technical support. It will be interesting to see if this news can help. We would suspect perhaps not, but stranger things have happened.
According to the release, GLPG1690 is a small molecule, selective autotaxin inhibitor which is fully proprietary to Galapagos. Galapagos identified the autotaxin target using its proprietary target discovery platform and developed molecule GLPG1690 as an inhibitor of this target. In the FLORA Phase 2a trial, patients on treatment with GLPG1690 showed improvement in forced vital capacity (FVC) at 12 weeks, with an encouraging safety profile. Galapagos received orphan drug designation for GLPG1690 in IPF from the US Food & Drug Administration (FDA) and European Commission (EC).
GALAPAGOS NV/S ADR (NASDAQ:GLPG) trumpets itself as a clinical-stage biotechnology company, discovers, develops, and commercializes novel medicines.
Its clinical stage programs include filgotinib, which is in Phase III clinical trials for the treatment of rheumatoid arthritis and Crohn’s disease, Phase 2/3 trials for ulcerative colitis, and Phase II trials for multiple additional indications; GLPG1690, an autotaxin inhibitor, which is in Phase III clinical trial for the treatment of idiopathic pulmonary fibrosis; GLPG1972 that completed Phase 1b clinical trial for the treatment of osteoarthritis; and MOR106, which is in Phase II trials for atopic dermatitis patients.
PINTA is a randomized, double-blind, placebo-controlled Phase 2 trial investigating a 100 mg once-daily oral dose of GLPG1205. The drug candidate or placebo will be administered for 26 weeks in up to 60 IPF patients. Patients may remain on their local standard of care as background therapy, whether or not they were previously or currently are treated with Esbriet®1 and Ofev®2. The primary objective of the trial is to assess the change from baseline in Forced Vital Capacity (FVC in mL) over 26 weeks compared to placebo. Secondary measures include safety, tolerability, pharmacokinetics and pharmacodynamics, time to major events, changes in functional exercise capacity, and quality of life. Recruitment for PINTA is planned in 10 countries in Europe, North Africa, and the Middle East.
The company has collaboration agreement with Gilead Sciences, Inc. for the development of filgotinib for inflammatory indications; Servier to develop GLPG1972; and AbbVie for the discovery, development, and commercialization of potentiator and corrector molecules for the treatment of cystic fibrosis, as well as with MorphoSys for MOR106.
Galapagos NV was founded in 1999 and is headquartered in Mechelen, Belgium.
As noted above, GLPG recently announced that it has dosed its first patient in the worldwide ISABELA Phase 3 program with autotaxin inhibitor GLPG1690 in IPF.
The stock has suffered a bit of late, with shares of GLPG taking a hit in recent action, down about -5% over the past week. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -6%.
“Today’s news again demonstrates our commitment to the rapid advancement of our IPF franchise, including the ISABELA and the PINTA trials. We are excited by the feedback received from participating sites and KOLs, which underscores the need for novel treatments to address the remaining high unmet need in IPF,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.
GALAPAGOS NV/S ADR (NASDAQ:GLPG) pulled in sales of $94.9M in its last reported quarterly financials, representing top line growth of 252.1%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($1.3B against $269.1M).