Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with dermatomyositis
- GLPG3667 is an investigational, novel, oral, reversible, and selective tyrosine kinase 2 (TYK2) inhibitor
- GLPG3667 is currently in development for the treatment of inflammatory and auto-immune diseases and, if approved, has the potential to be the first selective oral TYK2 inhibitor in dermatomyositis
Mechelen, Belgium; 23 May 2023, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was dosed in GALARISSO, the Phase 2 dermatomyositis (DM) trial with GLPG3667.
The GALARISSO Phase 2 trial (NCT05695950) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667. A daily oral administration of GLPG3667 150mg or placebo will be investigated in approximately 62 adult patients with DM over 24 weeks. The primary endpoint is the proportion of patients with at least minimal improvement in the signs and symptoms of DM at Week 24 according to the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) criteria.1
“We remain committed to delivering transformational medicines to patients living with severe immunological disorders and are pleased to further advance our novel, orally administered TYK2 inhibitor, GLPG3667, into Phase 2 development in dermatomyositis,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at Galapagos. “Dermatomyositis is a debilitating inflammatory disease marked by muscle weakness and a distinctive skin rash that can severely impact patients’ daily lives. There is a significant unmet need for effective and convenient treatment options for patients living with this rare disease, and we hope that our novel drug-candidate can help address this need and improve patient outcomes.”
GLPG3667 is an investigational drug and is not approved by any regulatory authority. Its efficacy and safety have not been established or fully evaluated by any regulatory authority.
Idiopathic inflammatory myopathies (IIM) are a heterogenous group of rare autoimmune disorders primarily affecting the proximal muscles. They are characterized by severe muscle weakness, muscle enzyme elevations, inflammation on muscle biopsy, and extra-muscular manifestations. DM is the most common form of IIM and is characterized by inflammatory and degenerative changes of the muscles and skin. Early symptoms of DM include distinct skin manifestations accompanying or preceding muscle weakness. The quality of life (QoL) of patients with DM is impaired due to muscle weakness, pain and skin disease activity.2 The overall mortality ratio in DM patients also remains three times higher when compared to the general population; with cancer, lung, and cardiac complications and infections being the most common causes of death.3 DM-specific prevalence has been estimated at one to six per 100,000 adults in the United States, and a recent analysis of 3,067 patients in the Euromyositis registry identified DM in 31% of the sampled patients.4 DM is a rare disease and with only one currently approved treatment, there is a high unmet need for alternative safe and effective treatment options.
Galapagos is a fully integrated biotechnology company united around a single purpose: to transform patient outcomes through life-changing science and innovation for more years of life and quality of life. We focus on the key therapeutic areas of immunology and oncology, where we have developed a deep scientific expertise in multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to commercialized programs and our first medicine for rheumatoid arthritis and ulcerative colitis is available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter.
+32 479 490 603
|Investor relations contact |
Sofie Van Gijsel
+1 781 296 1143
+32 495 58 46 63
This press release includes forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “will,” “can,” “commit,” “deliver,” “potential,” “remains,” “advance,” and “improve,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements related to our plans and strategy with respect to GLPG3667, including our planned Phase 2 clinical development in dermatomyositis with GLPG3667 and, the GALARISSO study, statements in relation to the envisaged timelines for the GALARISSO study, statements regarding patient enrollment for the Phase 2 program with our TYK2 inhibitor product candidate, GLPG3667, and statements regarding the timing or likelihood of approval for our product candidate, GLPG3667, for DM. Any forward-looking statements in this release are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause our actual results, performance or achievements to be materially different from any historic or future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that the clinical study with GLPG3667 for DM, GALARISSO, and any future clinical studies with GLPG3667 may not be completed in the currently envisaged timelines or at all, the inherent risks and uncertainties associated with competitive developments, clinical trial and product development activities, including with respect to the GALARISSO study, risks related to regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration of GLPG3667 due to safety, efficacy or other reasons), risks related to our reliance on collaborations with third parties, the risk that our estimations regarding our GLPG3667 development program and regarding the commercial potential of GLPG3667 may be incorrect, the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will need to revise our business plan, and risks related to the ongoing COVID-19 pandemic, as well as those risks and uncertainties identified in our most recent Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC), as supplemented and/or modified by any other filings and reports that we have made or will make with the SEC in the future. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if our results, performance or achievements are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release unless required by law or regulation.
1 Minimal improvement per ACR/EULAR is defined as a total improvement score (TIS) of >= 20 points. The TIS is a score derived from the evaluation of the results from 6 core set measurements of myositis disease activity.
2 Goreshi R, et al. Quality of life in dermatomyositis. J Am Acad Dermatol. 2011 Dec;65(6):1107-16.
3 Marie I. et al. Morbidity and mortality in adult polymyositis and dermatomyositis. Curr Rheumatol Rep. 2012 Jun;14(3):275-85.
4 DeWane ME, et al. Dermatomyositis: Clinical features and pathogenesis. J Am Acad Dermatol. 2020 Feb;82(2):267-281.
- Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with dermatomyositis
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Telesis Bio Announces Closing of $28.0 Million Private Placement of Preferred Stock And Warrants to Purchase an Additional $46.2 Million of Common Stock5.6.2023 23:30:00 CEST | Press release
SAN DIEGO, June 05, 2023 (GLOBE NEWSWIRE) -- Telesis Bio Inc. (NASDAQ: TBIO), a leader in molecular biology automation solutions for multi-omic and synthetic biology applications, today announced the closing of its private placement of redeemable convertible preferred stock and warrants resulting in initial gross proceeds of $28.0 million to Telesis Bio. The warrants issued in the private placement will provide Telesis Bio with approximately $46.2 million in additional gross proceeds if they are cash exercised. The financing was led by Novalis LifeSciences LLC with participation from Northpond Ventures, BroadOak Capital Partners and M-185 Corporation, an affiliate of the Company’s Chief Executive Officer and Founder, Todd R. Nelson, PhD. The Company also announced the appointment of Paul Meister, a partner at Novalis LifeSciences LLC, to the Company’s board of directors immediately following the closing. Please refer to the Company’s Form 8-K to be filed with the Securities and Exchang
Galapagos to showcase CAR-T point-of-care manufacturing and initial Phase 1/2 CLL data with CD19 CAR-T candidate, GLPG5201, at the EHA 2023 congress5.6.2023 22:01:00 CEST | Press release
All 7 out of 7 eligible patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter’s Transformation (RT), responded to treatment (Objective Response Rate of 100%)1 GLPG5201 showed no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICANS)2 A functionally closed, automated manufacturing platform for cell therapies at the point-of-care will be shown at the Galapagos booth A.103at the EHA 2023 congress Mechelen, Belgium; 5 June 2023,22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will feature theCAR-T point-of-care manufacturing platform and willpresent previously disclosed initial Phase 1/2 data with CD19 CAR-T candidate, GLPG5201, at the European Hematology Association (EHA) 2023 congress, taking place from 8 June to 11June 2023 in Frankfurt, Germany. “Patients who develop rrCLL and become resistant to new agents have a very poor prognosis and a significant high
Hoylu AB: Publicerar årsredovisning för 20225.6.2023 21:15:00 CEST | Pressemelding
Hoylu AB (publ) meddelar idag att årsredovisningen för räkenskapsåret 2022 bifogas detta pressmeddelande och finns tillgänglig på bolagets hemsida: (https://www.hoylu.com/investor-relations/financial-reports/). För mer information kontakta: Truls Baklid, CEO, +47 924 38 900 Email: email@example.com Karl Wiersholm, CFO, +1 425 829 2316 Email: firstname.lastname@example.org Om Hoylu Hoylus uppdrag är att ge distribuerade team möjlighet att samarbeta enkelt och sömlöst samtidigt som de alltid håller sig synkroniserade. Hoylus Adaptive Workspaces™ hjälper företag såväl stora som små att driva projekt, program och initiativ över olika tidszoner och kontinenter med samma engagemang och tydlighet som om alla arbetade i samma rum. För mer information: www.hoylu.com Kortnamn: Hoylu Marknadsplats: Nasdaq First North Growth Stockholm Certified Adviser: Mangold Fondkommission AB +46 (0) 8 50 301 550; email@example.com Publicering Informationen lämnades, genom ovanstående kontaktpersons försorg för offentliggörande den 5 ju
Hoylu AB: Publishes its Annual Report for 20225.6.2023 21:15:00 CEST | Press release
Hoylu AB (publ) announced today that the Annual Report for 2022 is attached to this press release and is available on Hoylu's web site: (https://www.hoylu.com/investor-relations/financial-reports/). For more information contact: Truls Baklid, CEO, +47 924 38 900 Email: firstname.lastname@example.org Karl Wiersholm, CFO, +1 425 829 2316 Email: email@example.com About Hoylu Hoylu’s visual collaboration technology empowers distributed teams to translate ideas into actions. Large enterprises as well as small and medium companies rely on Hoylu to run projects, programs, and initiatives across time zones and continents as seamlessly as when working in the same room. For more information: www.hoylu.com Try Hoylu for free: https://app.hoylu.com/ Ticker symbol: Hoylu Marketplace: Nasdaq First North Growth Market Certified Adviser: Mangold Fondkommission AB +46 (0) 8 50 301 550, firstname.lastname@example.org Publication The information was submitted for publication, through the agency of the contact person set out above, at 21:15 CE
Nokia Corporation: Repurchase of own shares on 05.06.20235.6.2023 20:00:00 CEST | Press release
Nokia Corporation Stock Exchange Release 5 June 2023 at 21:00 EEST Nokia Corporation: Repurchase of own shares on 05.06.2023 Espoo, Finland – On 5 June 2023 Nokia Corporation (LEI: 549300A0JPRWG1KI7U06) has acquired its own shares (ISIN FI0009000681) as follows: Trading venue (MIC Code)Number of sharesWeighted average price / share, EUR*XHEL308,5933.85CEUX48,4053.86AQEU4,7293.86TQEX3,3733.87Total365,1003.86 * Rounded to two decimals On 3 February 2022, Nokia announced that its Board of Directors is initiating a share buyback program under the authorization granted by Nokia’s Annual General Meeting on 8 April 2021 to return up to EUR 600 million of cash to shareholders in tranches over a period of two years. The second phase of the share buyback program in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR), the Commission Delegated Regulation (EU) 2016/1052 and under the authorization granted by Nokia’s Annual General Meeting on 5 April 2022 started on 2 January 2023 and en