A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration

A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.

Start Date07 Jun 2021

Sponsor / Collaborator

Galapagos NV

NCT04700280

/ TerminatedPhase 2

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's Syndrome

This is a first exploration of GLPG3970 in participants with active primary Sjogren's Syndrome (pSS) to evaluate the efficacy, safety and tolerability and to determine its pharmacokinetics (PK) profile compared to placebo.

Start Date28 Jan 2021

Sponsor / Collaborator

Galapagos NV

NCT04708184

/ CompletedPhase 1

A Randomized, Open-label, 3-period, Single-dose, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of GLPG3970 Given as an Oral Tablet Formulation Versus the Oral Solution Formulation of GLPG3970 and to Assess the Effect of Food on the Oral Tablet Formulation.

This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.

Start Date11 Jan 2021

Sponsor / Collaborator

Galapagos NV

100 Clinical Results associated with GLPG-3970

100 Translational Medicine associated with GLPG-3970

100 Patents (Medical) associated with GLPG-3970

Literatures (Medical) associated with GLPG-3970

01 Feb 2025·CLINICAL PHARMACOLOGY & THERAPEUTICS

Effects of GLPG3970 on Sulfasalazine and Methotrexate Pharmacokinetics in Healthy Adults: Two Open‐Label, Phase I, Drug–Drug Interaction Studies

Article

Author: Gistelinck, Fien ; Bellaire, Susan ; Dao, Justine ; Zabela, Volha ; van der Plas, Mariska

GLPG3970 is a selective salt‐inducible kinase 2/3 inhibitor intended for the treatment of inflammatory diseases. In vitro studies suggest GLPG3970 strongly inhibits breast cancer resistance protein (BCRP), indicating a possible interaction with BCRP substrates such as sulfasalazine (SSZ; a probe substrate for intestinal BCRP inhibition) and methotrexate (MTX), both inflammatory disease medications. Two open‐label, nonrandomized, phase I, drug–drug interaction (DDI) studies assessed the pharmacokinetics of SSZ 1,000 mg (NCT04720183) and MTX 7.5 mg (EudraCT: 2020‐000391‐37) with and without GLPG3970 350 mg. Healthy participants aged 18–55 years with wild‐type homozygous BCRP genotype (c421C/C) received: SSZ on day (D)1, GLPG3970 + SSZ on D5, and GLPG3970 2 hours after SSZ on D9 (N = 8; SSZ/GLPG3970 DDI study); MTX on D1, GLPG3970 + MTX on D5, and GLPG3970 on D6–8 (N = 15; MTX/GLPG3970 DDI study). Primary end points were AUC and Cmax (“exposure”) of SSZ and its metabolite (sulfapyridine [SPD]), SPD:SSZ AUC ratio (SSZ/GLPG3970 study), and AUC and Cmax (“exposure”) of MTX (MTX/GLPG3970 study). DDIs were evaluated using the geometric mean ratio of each end point; a > 2‐fold increase in SSZ or MTX exposure was deemed clinically relevant. GLPG3970 demonstrated mild inhibition of intestinal BCRP in vivo: GLPG3970 + SSZ increased SSZ exposure ~1.7–1.8‐fold and decreased SPD:SSZ ratio ~ 2‐fold vs. SSZ alone. GLPG3970 administered 2 hours after SSZ did not change the magnitude of the interaction. GLPG3970 + MTX had no relevant effect on MTX pharmacokinetics vs. MTX alone. Therefore, the strong in vitro BCRP inhibition was not confirmed in vivo. No safety concerns were observed when GLPG3970 was coadministered with SSZ or MTX.

11 Apr 2024·Journal of medicinal chemistryQ1 · MEDICINE

Discovery of Clinical Candidate GLPG3970: A Potent and Selective Dual SIK2/SIK3 Inhibitor for the Treatment of Autoimmune and Inflammatory Diseases

Q1 · MEDICINE

Article

Author: López-Ramos, Miriam ; Dupont, Sonia ; Amantini, David ; Joncour, Agnes ; Jary, Hélène ; Merciris, Didier ; Pereira Fernandes, Anna ; Desroy, Nicolas ; Roca Magadan, Carlos ; Tirera, Amynata ; Andrews, Martin ; Bucher, Denis ; De Vos, Steve ; Dos Santos, Aurélie ; Lavazais, Stephanie ; Temal-Laib, Taouès ; Drennan, Michael ; Monjardet, Alain ; Delachaume, Carole ; Jimenez, Juan-Miguel ; Borgonovi, Monica ; Wakselman, Emanuelle ; Laenen, Wendy ; Brys, Reginald ; Peixoto, Christophe ; Saccomani, Corinne

The salt-inducible kinases (SIKs) SIK1, SIK2, and SIK3 belong to the adenosine monophosphate-activated protein kinase (AMPK) family of serine/threonine kinases. SIK inhibition represents a new therapeutic approach modulating pro-inflammatory and immunoregulatory pathways that holds potential for the treatment of inflammatory diseases. Here, we describe the identification of GLPG3970 (32), a first-in-class dual SIK2/SIK3 inhibitor with selectivity against SIK1 (IC₅₀ of 282.8 nM on SIK1, 7.8 nM on SIK2 and 3.8 nM on SIK3). We outline efforts made to increase selectivity against SIK1 and improve CYP time-dependent inhibition properties through the structure-activity relationship. The dual activity of 32 in modulating the pro-inflammatory cytokine TNFα and the immunoregulatory cytokine IL-10 is demonstrated in vitro in human primary myeloid cells and human whole blood, and in vivo in mice stimulated with lipopolysaccharide. Compound 32 shows dose-dependent activity in disease-relevant mouse pharmacological models.

News (Medical) associated with GLPG-3970

24 Feb 2023

·endpts.com

Galapagos goes 0-for-3 on inflammation program as it cuts an early-stage candidate

Galapagos has cut anti-inflammatory drug candidate GLPG4399 following the completion of an early-stage healthy volunteer trial, according to its 2022 annual report released Thursday afternoon. GLPG4399 was a SIK3 inhibitor, one in a line of such salt-inducible kinase (SIK) inhibitors that Galapagos has been trying to develop for inflammatory diseases like rheumatoid arthritis and ulcerative colitis. Originally, the biotech had been planning to move the drug forward in a study with rheumatoid arthritis patients in the middle of this year, but now it’s halting the program and going back to search for new SIK inhibitors. “Medicinal chemistry activities to identify SIK inhibitors with improved pharmacology continues,” Galapagos noted briefly in its press release. GLPG4399 was the third SIK inhibitor Galapagos brought out of the clinic — all part of a franchise Galapagos dubbed Toledo. The first candidate, GLPG3312, similarly only made it through healthy volunteer studies before Galapagos scrapped it. The second, GLPG3970, disappointed in Phase II trials in ulcerative colitis and rheumatoid arthritis, and though it showed some signs of efficacy in psoriasis, Galapagos opted to toss that candidate as well. The small pipeline prune comes after Galapagos laid off 200 staffers and discontinued work on its fibrosis and kidney disease programs, cuts that followed a long string of setbacks at the biotech. In December, Galapagos also announced that its chief business officer André Hoekema and chief medical officer Walid Abi-Saab are retiring, though the latter is remaining with the company until the end of May. Galapagos shares $GLPG fell almost 8% after the markets opened Friday. The biotech did not immediately return request for comment.

Phase 2Clinical Trial Failure

26 Jul 2022

·www.prnewswire.com

New Therapeutics Options in Rheumatoid Arthritis Pipeline as 120+ Key Companies are Working on Drug Profiles | DelveInsight

Rise in prevalence of rheumatoid arthritis, increase in demand for rheumatoid arthritis drugs, the entry of biosimilar drugs, the surge in geriatric population are the key factors driving the development of potential treatment of Rheumatoid arthritis. Major key players include Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, and others. LAS VEGAS, July 26, 2022 /PRNewswire/ -- DelveInsight's ' Rheumatoid Arthritis Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline rheumatoid arthritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the rheumatoid arthritis pipeline domain. Key Takeaways from the Rheumatoid Arthritis Pipeline Report DelveInsight's rheumatoid arthritis pipeline report depicts a robust space with 120+ active players working to develop 120 + pipeline therapies for rheumatoid arthritis treatment. Key rheumatoid arthritis companies such as Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others are evaluating novel rheumatoid arthritis treatment drugs candidate to improve the treatment landscape. Promising rheumatoid arthritis pipeline therapies in various stages of development includes TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others. In July 2022, Enosi Therapeutics, announced a partnership with Danuo Science Group, based in Hong Kong, to further develop two products currently in Enosi's pipeline for Greater China. Enosi's Growth Factor Trap (EN-2000 Program) and TNFR1 Blocker (EN-1000 Program) were licensed as part of the partnership. Both programs have the potential to be used as cross-over drugs to treat cancer and autoimmune diseases. EN-2000 blocks inflammatory growth factors that drive cancer and rheumatoid arthritis while EN-1000 is a specific blocker of TNFR1, which Enosi believes may be useful in treating autoimmune disease. In February 2022, Biogen Inc. and Xbrane Biopharma AB announced that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane™, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA® (certolizumab pegol). In June 2022, Biogen Inc. and Bio-Thera Solutions, Ltd. presented positive Phase III data for BIIB800 (BAT1806), a biosimilar candidate referencing. The double-blind 52-week Phase III study randomized 621 patients with moderate to severe rheumatoid arthritis to receive either BIIB800 or the reference tocilizumab administered intravenously every 4 weeks at a dose of 8 mg/kg for the first 24 weeks. Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product. In June 2022, Revolo Biotherapeutics announced that it was awarded an Innovative Medicines Designation, or Innovation Passport, from the Medicines and Healthcare products Regulatory Agency (MHRA) for its immune-resetting drug candidate, '1805, for the treatment of patients with moderately to severely active Rheumatoid Arthritis (RA). In February 2022, Revolo Biotherapeutics secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate two Phase II trials of its autoimmune disease drug candidate '1805. One of the trials will enrol moderate-to-severe active rheumatoid arthritis (RA) patients while another Phase II trial will have individuals with non-infectious, active, intermediate, or posterior uveitis or panuveitis. In December 2021, Theramex, entered into an agreement with Enzene Biosciences Limited to develop, register, and commercialize a biosimilar drug of Roche's reference medicine RoActemra (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialized from 2026 in Europe, the UK, Switzerland, and Australia. Obefazimod is an oral, first-in-class, small molecule being developed by Abivax in Phase II stage of development. Obefazimod generated promising pre-clinical data from collagen-induced arthritis animal models that were the basis for moving into the Phase IIa clinical trial in rheumatoid arthritis (RA). Zunsemetinib, an Investigational Oral MK2 Inhibitor, is being developed by Aclaris Therapeutics. Aclaris initiated study activities and began activating sites in December 2021 in the following two studies: ATI-450-RA-202: Phase IIb clinical trial of zunsemetinib in subjects with moderate to severe rheumatoid arthritis (RA). This is Aclaris' second Phase II clinical trial of zunsemetinib in subjects with moderate to severe RA and is primarily designed to assess the efficacy of multiple doses of zunsemetinib to aid in the selection of an optimal dose to progress in future development. Request a sample and discover the recent advances in rheumatoid arthritis treatment @ Rheumatoid Arthritis Pipeline Outlook The rheumatoid arthritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage rheumatoid arthritis products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the rheumatoid arthritis pipeline landscape. Rheumatoid Arthritis Overview Rheumatoid arthritis is classified as an autoimmune disorder. It occurs when the immune system, which is supposed to defend, malfunctions and begins to attack our own tissues. It causes inflammation in the lining of the joints (the synovium). As a result, joints may become red, warm, swollen, and painful, which are common rheumatoid arthritis symptoms. The exact rheumatoid arthritis causes are still unknown. Rheumatoid arthritis can be difficult to detect in its early stages since the early signs and symptoms are similar to those of many other diseases. There is no single blood test or physical finding that can validate the rheumatoid arthritis diagnosis. Rheumatoid arthritis has no known cure. However, rheumatoid arthritis clinical trials show that remission of symptoms is more frequent when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines started early (DMARDs). Find out more about rheumatoid arthritis treatment @ Rheumatoid Arthritis Treatment Drugs A snapshot of the Rheumatoid Arthritis Pipeline Drugs mentioned in the report: Learn more about the novel and emerging rheumatoid arthritis pipeline therapies @ Rheumatoid Arthritis Clinical Trials Rheumatoid Arthritis Therapeutics Assessment The rheumatoid arthritis pipeline report proffers an integral view of rheumatoid arthritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Rheumatoid Arthritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-ocular, Intra-articular, Intrathecal, Intravenous, Oral, Parenteral, Ophthalmic, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Interleukin 6 inhibitor, Tumour necrosis factor-alpha inhibitor, CD22 antigen inhibitor, Janus kinase 1 inhibitor, B cell activating factor inhibitor, Granulocyte-macrophage colony-stimulating factor antagonist, Toll-like receptor 4 antagonist, Emt protein-tyrosine kinase inhibitor, Fibroblast growth factor modulators; T lymphocyte inhibitors, Bacteria replacements. Key Rheumatoid Arthritis Companies: Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Amgen, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others Key Rheumatoid Arthritis Pipeline Therapies: TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others. Dive deep into rich insights for drugs for rheumatoid arthritis, visit @ Rheumatoid Arthritis Medications Table of Contents For further information on the rheumatoid arthritis pipeline therapeutics, reach out @ Drugs for Rheumatoid Arthritis Related Reports Rheumatoid Arthritis Market Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key rheumatoid arthritis companies including Abivax, UCB, Sierra Oncology, Taisho, among others. Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Persistent Depressive Disorder Market | Gene Therapy for Ocular Rare Disease Market | Congestive Heart Failure Market | CRISPR Therapies Pipeline | Desmoplastic Small Round Cell Tumors Market | India Healthcare Outlook Report | Psychosis Market | Dental Lasers Market | Primary Immune Deficiency Market I Dyslipidemia Market | Lateral Epicondylitis Disease Market | Castration-Resistant Prostate Cancer Market | Metrorrhagia Market | Global Messenger RNA-based Vaccines and Therapeutics Market | Negative Pressure Wound Therapy Systems Market | US Healthcare Outlook Report | Mucinous Cystic Neoplasms Market | Hot Flashes Market | Varicose Veins - Market | Hemostats Market | Injectable Drug Delivery Devices Market | Breast Pumps Market | Physiotherapy Equipment Market | Trastuzumab Biosimilars Insight | Deep Brain Stimulation Devices Market | Retinoblastoma Market | Venous Stenosis Market | Tumor Ablation Market | Substance Abuse Market | Insulin Glargine Biosimilar Insight | Interspinous Spacers Market | Anti-hypertension Market Latest Healthcare Blogs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juveline Idiopathic Arthritis Therapy Market About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

31 Aug 2021

·www.biospace.com

Departure of Founder and CEO Heightens Uncertainty for Galapagos

As CEO, Stolpe has presided over some highs with the launch of JAK1 inhibitor Jyseleca (filgotinib) in Europe, as well as the devaluation of the company’s share price by 70%. Galapagos co-founder and chief executive officer Onno van de Stolpe has been in this position with the Belgian biotech for 22 years and is ready to step down, paving the way for new leadership. As CEO, Stolpe has presided over some highs with the launch of JAK1 inhibitor Jyseleca ® (filgotinib) in Europe, as well as the devaluation of the company’s share price by 70% . Stolpe is to stay in his role until a successor is found, the company announced in a statement . Because the biotech has been on potential buyers’ radar as a takeover target/merger candidate, the co-founder’s departure leaves the future of the business uncertain. Putting up a brave face, the CEO tweeted on his exit announcement, “Of course it would have been better if Galapagos was in a better situation. But I will leave a company with €5b in cash, guaranteed independence…” But there is no way of knowing for how long. Galapagos has left many of its investors feeling disheartened after seeing great success throughout 2019 and the beginning of 2020. In 2019, Galapagos and Gilead Sciences signed a 10-year deal worth $5.1 billion, which gave Gilead full access to Galapagos’s product pipeline. Under the terms of the agreement, Gilead gained access to a portfolio of innovative molecules, including six in clinical trials and more than 20 in preclinical development. A partnership with a multinational pharmaceutical company was termed a sure sign of Galapagos’ success since most biotechs tend to get immediate benefits from such relationships. However, there has been more than one disappointment in Gilead’s buy-in and it appears that the deal is crumbling. A string of disappointments has besieged the Belgian biotech. Despite its massive funding and new resources, Galapagos has yet to capitalize on the Gilead deal. In Galapagos’ product pipeline, the drug filgotinib was stated to be a cornerstone development with partner Gilead for rheumatoid arthritis. With a market of $36.11 billion projected for rheumatoid arthritis drugs by 2027, the company was eager to tap into the market. However, as part of a broader investigation into the safety of the drug class, the U.S. Food and Drug Administration rejected the drug due to potential testicular toxicity concerns. This resulted in the pair missing out on a multibillion-dollar opportunity, resulting in a stock price drop of 63% compared to last year. The FDA rejection led Gilead to give back the European marketing rights to Galapagos and abandon its development plans for the drug in the US. As Gilead designated Galapagos as the sole commercialization company for the drug, Galapagos is about to launch Jyseleca in Europe and Japan for rheumatoid arthritis. Galapagos is set to face an uphill battle in the commercialization of drugs and medicines, however, since it can be a very challenging process for small biotech companies. The failures continued to pile up. Another molecule canned was AdamTS-5 inhibitor GLPG1972, which missed the mark in a phase 2 trial in osteoarthritis last year. Again in early February, Galapagos and Gilead decided to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The original formulation of ziritaxestat was developed by Galapagos to inhibit autotaxin, an enzyme thought to be responsible for IPF progression. Ziritaxestat’s ex-European rights were licensed to Gilead, which was sharing Phase III trial costs. Ziritaxestat was developed for the treatment of idiopathic pulmonary fibrosis and was set to penetrate a market that could generate up to $1 billion in sales annually. The dream, however, came undone this February. In May, Galapagos decided to refocus its clinical pipeline and make some cost adjustments expected to save the company €150 million. The Belgian biotech, however, just kept suffering disappointment after disappointment. Lead asset, GLPG3970 turned out to be another failed candidate in the ‘Toledo’ project, which aims to treat a broad range of autoimmune conditions with a range of SIK drugs. Following the failure of two out of three clinical trials of GLPG3970, Galapagos had no choice but to return to the drawing board last month with its SIK inhibitor program. After a Phase I trial with GLPG3312, Galapagos abandoned another Salt-inducible Kinase (SIK) 1/2/3 inhibitor. Though the company still has another idiopathic pulmonary fibrosis drug in its pipeline, these developments allow other companies to break into the market before Galapagos. Though Gilead and Galapagos intend to continue to broaden their pipelines to boost business, their blockbuster relationship has so far done nothing but disappoint. The exit of the CEO marks yet another downturn. “My time at the helm of Galapagos will come to an end. We have built a great company that bridges novel target discovery all the way to new medicines in the clinic and to the patient. Despite recent setbacks, we continue to progress a deep pipeline of novel target-based compounds, while the commercial roll-out of our first approved product is underway,” Stolpe said in a statement. Dr. Raj Parekh, chairman of the Galapagos supervisory board added in the statement that Stolpe has built one of the most important biotechnology companies in Europe, guiding it from a new start-up to a public company that recently launched its first approved medicine. Incidentally, two weeks ago, Galapagos’ chief scientific officer Piet Wigerinck announced that he would end his nine-year term at the company later this year. The question now doing the rounds is: Will the new CEO help Galapagos optimize its position in the European and Japanese market, or will a European heavyweight decide to purchase Galapagos to maximize its exposure and sales of filgotinib in Europe? Only time will tell.

Phase 1Phase 3Phase 2Executive ChangeDrug Approval

100 Deals associated with GLPG-3970

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Sjögren's syndrome	Phase 2	Germany	Galapagos NV	28 Jan 2021
Primary Sjögren's syndrome	Phase 2	Greece	Galapagos NV	28 Jan 2021
Primary Sjögren's syndrome	Phase 2	Hungary	Galapagos NV	28 Jan 2021
Primary Sjögren's syndrome	Phase 2	Poland	Galapagos NV	28 Jan 2021
Primary Sjögren's syndrome	Phase 2	Ukraine	Galapagos NV	28 Jan 2021
Rheumatoid Arthritis	Phase 2	Bulgaria	Galapagos NV	12 Oct 2020
Rheumatoid Arthritis	Phase 2	Georgia	Galapagos NV	12 Oct 2020
Colitis, Ulcerative	Phase 2	United States	Galapagos NV	05 Oct 2020
Colitis, Ulcerative	Phase 2	Georgia	Galapagos NV	05 Oct 2020
Colitis, Ulcerative	Phase 2	Poland	Galapagos NV	05 Oct 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04700280 (GLIDER, CTgov)	Phase 2	Primary Sjögren's syndrome	31	GLPG3970 (GLPG3970)	apwiilurix(gbdghyrtbx) = utffxocdxw prykebivyt (ztpmblkoqn, 1.56) View more	-	18 Sep 2023
				Placebo (Placebo)	apwiilurix(gbdghyrtbx) = buapwqpfpi prykebivyt (ztpmblkoqn, 2.03) View more
NCT04577794 (SEA TURTLE, CTgov)	Phase 2	Colitis, Ulcerative	31	GLPG3970 (GLPG3970)	ipvylymoqx(bxlrloasgt) = oretwxfzzn ostimdmvfl (hwkyhzqwat, 0.57) View more	-	27 Jan 2023
				Placebo (Placebo)	ipvylymoqx(bxlrloasgt) = iryvebswez ostimdmvfl (hwkyhzqwat, 0.85) View more
NCT04577781 (LADYBUG, CTgov)	Phase 2	Rheumatoid Arthritis	28	GLPG3970 (GLPG3970)	ieltbygrxd(gikyyhimoo) = tdoyljxapi xfsqbdnvzv (kqfwzndsnq, 0.224) View more	-	18 Jul 2022
				Placebo (Placebo)	ieltbygrxd(gikyyhimoo) = rhviqvbpuv xfsqbdnvzv (kqfwzndsnq, 0.258) View more
NCT04106297 (CALOSOMA, NEWS) Manual	Phase 1	Inflammation	26	GLPG-3970	mnrckxurxh(tqoawxjqfj) = keptleyxur zoamglwutw (dvfwyrnxtu )	Positive	14 Jul 2021
				Placebo	mnrckxurxh(tqoawxjqfj) = vmggtxooic zoamglwutw (dvfwyrnxtu )
NCT04577781 (GlobeNewswire) Manual	Phase 2	Inflammation	28	GLPG-3970	ngpbkzyszk(mksadmpnwy) = sdwnxnsjvo trmrztbsly (mtdeludpgt )	Negative	14 Jul 2021
				Placebo	ngpbkzyszk(mksadmpnwy) = dqpkedqion trmrztbsly (mtdeludpgt )
NCT04577794 (SEA TURTLE, Corporate Publications) Manual	Phase 2	Ulcerative colitis, active severe	31	GLPG-3970	jeykirazcz(fisrbbccum) = aoexeajclo ugmwdnsmjo (gfbzvegfiw ) View more	Negative	14 Jul 2021
				Placebo	jeykirazcz(fisrbbccum) = hwkqfzkdql ugmwdnsmjo (gfbzvegfiw ) View more

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