Galapagos NV GLPG announced that it has dosed the first patient in the phase I CALOSOMA study evaluating its Toledo compound GLPG3970 for the treatment of psoriasis. The double-blind, placebo-controlled study is examining the safety, tolerability, PK and PD of GLPG3970 in single and multiple ascending doses in healthy male adults with moderate-to-severe psoriasis.
Notably, the CALOSOMA study is one of the three studies currently enrolling patients to evaluate the safety and efficacy GLPG3970 for various inflammatory diseases. Apart from psoriasis, Galapagos is developing GLPG3970 for addressing ulcerative colitis (UC) and rheumatoid arthritis (RA).
The placebo-controlled phase II SEA TURTLE study is evaluating the efficacy, safety, tolerability, PK and PD of GLPG3970 for treating moderately to severely active UC. The primary endpoint of this study is to see the change from baseline in total Mayo Clinical Score (MCS) for the given patient population.
Moreover, the placebo-controlled phase II LADYBUG study is currently evaluating the efficacy, safety, tolerability, PK and PD of GLPG3970 in participants with severely active RA and an inadequate response to methotrexate.
Additionally, Galapagos plans to launch two additional phase II studies on GLPG3970 in early 2021 for treating Sjögren’s and systemic lupus erythematosus.
Per the company, Toledo is a name used for a novel target class for various autoimmune and fibrotic diseases. GLPG3970 demonstrated an encouraging preclinical activity in several inflammatory diseases, such as inflammatory bowel diseases, RA and psoriasis. The company expects this Toledo program to be a new paradigm in the treatment of inflammatory diseases.
Shares of Galapagos have plunged 31.4% so far this year against the industry’s increase of 2.4%.
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We remind investors that last week, the European Commission granted an approval to Jyseleca (filgotinib 200 mg and 100 mg tablets) as a monotherapy or in combination with methotrexate (MTX) for treating rheumatoid arthritis (RA) in patients who had previously shown an inadequate response or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Jyseleca is the first-approved drug in the Galapagos portfolio, which should drive its growth ahead. The company will receive a milestone payment of $75 million from its partner Gilead Sciences GILD in relation to the approval of the drug in Europe, per their collaboration agreement.
Zacks Rank & Stocks to Consider
Galapagos currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the healthcare sector include Emergent BioSolutions Inc. EBS and Horizon Therapeutics Public Limited Company HZNP, both presently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have been revised 23.9% upward for 2020 and 25.7% for 2021 over the past 60 days. The stock has surged 91.5% year to date.
Horizon Therapeutics’ earnings estimates have moved 43% north for 2020 and 42.3% for 2021 over the past 60 days. The stock has skyrocketed 114.6% year to date.
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