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    GLPG   BE0003818359

GALAPAGOS NV

(GLPG)
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Galapagos NV Demonstrates Early Clinical Activity with SIK2/3 Inhibition in Inflammation

07/14/2021 | 04:01pm EDT

Galapagos NV reported topline results with GLPG3970 in three patientstudies.GLPG3970, the first product candidatefrom a broad portfolio of SIK inhibitor compounds, provides clinicaldatasupporting the role of SIK inhibition in inflammation. SIK is a novel target class discovered by Galapagos. Galapagos evaluated GLPG3970, a proprietary salt inducible kinase (SIK) 2/3 inhibitor, in three randomized, placebo-controlled, double-blind studies: a Phase 1b study in patients with moderate to severe psoriasis and two Phase 2a studies in patients with moderate to severely active UC and RA. GLPG3970 or placebo were administered orally once-daily for 6 weeks. Main objectives were to evaluate the safety and tolerability of GLPG3970 as well as early signs of biologic and clinical effect. Across the three studies, GLPG3970 was generally safe and well tolerated. There were no deaths nor serious adverse events, and the majority of treatment emergent adverse events (TEAEs) were mild or moderate in nature. CALOSOMA study: Phase 1b trial in psoriasis - This study randomized 26 patients with moderate to severe psoriasis in a 3:2 ratio, GLPG3970 to placebo. Two out of 15 patients discontinued in the treatment arm (COVID-19 and pruritus) versus 1 out of 11 on placebo (psoriatic arthropathy). At Week 6, four out of 13 patients on GLPG3970 had a PASI1 50 response, defined as at least a 50% improvement of baseline PASI, compared to none on placebo. Specifically, the four responders achieved 50%, 50%, 56%, and 77% improvement in their PASI scores from baseline, reaching statistical significance compared to placebo (p=0.002) at Week 6. Positive signals of clinical effect were also consistently observed for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at Week 6. LADYBUG study: Phase 2a trial in RA - This study randomized 28 patients with moderate to severely active RA and an inadequate response to methotrexate in a 3:2 ratio, GLPG3970 to placebo. Three out of 16 patients discontinued in the treatment arm (COVID-19, ALT increase and physician decision) versus 2 out of 12 on placebo (COVID-19). At Week 6, patients on GLPG3970 showed no differentiation from placebo on change from baseline DAS28 (CRP)2 response (GLPG3970 -1.29, placebo -1.24), nor on the majority of other efficacy endpoints. GLPG3970 is the first compound from Galapagos’ broad portfolio of novel molecules to provide clinical evidence for the potential role of SIK inhibition in inflammation. Biomarker data from these signal-finding studies with GLPG3970 will be further analyzed for signature profiles. The company's aim with the Toledo program is to explore this novel mode of action fully and bring forward improved molecules directed toward SIK2/3 as well as other SIK selectivity profiles. Galapagos currently has two compounds exhibiting SIK2/3 inhibition in preclinical development. Galapagos intends to submit study outcomes with GLPG3970 for publication at scientific conferences and in peer-reviewed medical journals.


ę S&P Capital IQ 2021
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Financials
Sales 2021 519 M 609 M 609 M
Net income 2021 -224 M -263 M -263 M
Net cash 2021 3 243 M 3 801 M 3 801 M
P/E ratio 2021 -15,0x
Yield 2021 -
Capitalization 2 984 M 3 494 M 3 497 M
EV / Sales 2021 -0,50x
EV / Sales 2022 -0,37x
Nbr of Employees 1 397
Free-Float 73,8%
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Mean consensus HOLD
Number of Analysts 10
Last Close Price 45,53 €
Average target price 59,71 €
Spread / Average Target 31,1%
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Managers and Directors
Onno van de Stolpe Chief Executive Officer
Bart Filius President & Chief Operating Officer
Raj B. Parekh Chairman
Piet Wigerinck Chief Scientific Officer
Walid Abi-Saab Chief Medical Officer
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