
Galapagos and Servier report topline results for ROCCELLA Phase 2 clinical trial with GLPG1972/S201086 in knee osteoarthritis patients
Mechelen, Belgium and Paris, France, 15 OCTOBER 2020, 22.01 CET; regulated information –Servier and Galapagos NV (Euronext & NASDAQ: GLPG) report that no signal of activity was observed in the topline results in their ROCCELLA Phase 2 trial with GLPG1972/S201086.
ROCCELLA is a global, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in 932 patients with knee osteoarthritis (OA) over 52 weeks of treatment. The study population was aged between 40 to 76 years (mean age was 63), mainly female (70%), and with a mean disease duration of 7 years.
The primary objective of ROCCELLA was to demonstrate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo after 52 weeks of treatment in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI.
The trial failed to meet the primary objective. The change from baseline to week 52 in cartilage thickness, in mm (SD) was -0.116 (0.27) for the placebo group and -0.068 (0.20), -0.097 (0.27) and -0.085 (0.22), for the low, medium and high dose, respectively. Statistically significant difference versus placebo was not reached in any of the treated groups.
There was no significant difference compared to placebo observed on secondary endpoints, including clinical outcomes.
Additional analyses are being conducted to fully evaluate the results, which will be presented at upcoming medical conferences.
GLPG1972/S201086 was generally well-tolerated by patients in this Phase 2 trial.
“While we are disappointed that ADAMTS-5 inhibition by GLPG1972/S201086 proved not to make a difference in this trial,we want to express our gratitude to all participating patients and investigators. This study result, while not what we hoped for, does add to the body of knowledge to help fight OA, a disease with substantial unmet medical need,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.
“We are pleased to have performed this study with Galapagos. Unfortunately, the ROCCELLA results provided insufficient evidence of GLPG1972/S201086 efficacy in patients with knee osteoarthritis. We acknowledge the importance of assessing this innovative mechanism of action in the clinical setting and we will continue analyzing the data for better knowledge of the disease for the benefit of the patients and for future developments. We would like also to thank all patients and investigators for participating in this very important study,” said Dr. Patricia Belissa-Mathiot, Director of Clinical Development and R&D Chief Medical Officer at Servier.
About the ROCCELLA trial
ROCCELLA was a multi-regional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in patients with knee osteoarthritis. ROCCELLA included 932 patients in 12 countries in Europe, Asia, North and South America. Galapagos was responsible for ROCCELLA in the United States, where 326 patients were recruited. Servier was responsible for this trial in 11 countries, where 606 patients were recruited.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
About Servier
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 150 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22,000 people worldwide. Entirely independent, the Group invests on average 25% of its total revenue (excluding generics) every year in research and development and uses all its profits for its development. Corporate growth is driven by Servier’s constant commitment in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, oncology and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. More information: www.servier.com.
Contacts Galapagos
Investor contacts Galapagos: Elizabeth Goodwin VP IR +1 781 460 1784 Sofie Van Gijsel Senior Director IR +32 485 19 14 15 ir@glpg.com | Media contacts Galapagos: Carmen Vroonen Global Head of Communications & Public Affairs +32 473 82 48 74 Anna Gibbins Senior Communications Director - Therapeutic Areas +44 7717 801900 communications@glpg.com |
Contacts Servier:
Media Relations:
Sonia Marques : presse@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13
Jean-Clément Vergeau : presse@servier.com – Tel. +33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96
Galapagos forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with GLPG1972/S201086 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG1972/S201086 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including our collaboration partner for GLPG1972/S201086, Servier) and that Galapagos’ estimations regarding its GLPG1972/S201086 development program and regarding the commercial potential of GLPG1972/S201086, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).
Attachment
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.About GlobeNewswire by notified
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
Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release
Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a
DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release
Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68
Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release
Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.
Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release
AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us
Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release
VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin