Biogen Announces AFFINITY Phase 2 Trial Initiation for Opicinumab (Anti-LINGO-1) in Multiple Sclerosis
Biogen (NASDAQ: BIIB) announced today the recent initiation of the Phase 2 clinical trial AFFINITY, designed to evaluate opicinumab as an investigational add-on therapy in people with relapsing multiple sclerosis (MS). The trial follows the comprehensive review of SYNERGY, a Phase 2 trial, which identified a specific population that may be more likely to respond to treatment.
These data are being presented at MSParis2017, the seventh Joint Meeting of the European Committee for Treatment and Research in MS and Americas Committee for Treatment and Research in MS (ECTRIMS-ACTRIMS; 25 – 28 October).
The post-hoc analysis of SYNERGY data indicated an increased clinical effect of opicinumab versus placebo (when used at the same time as interferon beta-1a intramuscular injection) in patients who had the disease for shorter periods of time and in whom MRI showed certain brain features that suggest repair of MS lesions may be possible through remyelination.1
“As part of our long-standing commitment to the MS community, Biogen remains dedicated to advancing the treatment of MS and continues to pursue next-generation research to understand the therapeutic potential of repairing damage caused by the disease,” said Michael Ehlers, executive vice president, Research & Development at Biogen. “The SYNERGY data provide intriguing evidence that opicinumab, which has demonstrated remyelination properties in a previous Phase 2 study, may have a treatment effect in certain patients.”
The recently-initiated AFFINITY study is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study that aims to enroll 240 people with relapsing MS. It will evaluate opicinumab as an add-on therapy in patients who are adequately controlled on their anti-inflammatory disease-modifying therapy (DMT), versus the DMT alone. The primary endpoint of the study, Overall Response Score (ORS), is an integrated measure of both the improvement and worsening of disability over time.
“When analyzing the SYNERGY results, we discovered which patients with relapsing MS may be more responsive to opicinumab, and this became a significant component of the trial design for AFFINITY,” said Professor Gavin Giovannoni, chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry. “We now have an exciting opportunity to apply a more precise biological approach when evaluating the potential of opicinumab as a therapy that may improve patients’ disability and lead to a better overall outcome.”
Data on opicinumab will be presented as follows:
- Predictors of an Opicinumab Treatment Effect and Identification of an Efficacy Subpopulation: A Post Hoc Analysis of the SYNERGY Study – Poster P718 – Thursday, 26 October, 15:30-17:00 CET
- Overall Response Score: A Novel Disability Endpoint That Allows for the Integrated Assessment of Improvement and Worsening Over Time in Patients with MS – Poster P777 –Thursday, 26 October, 15:30-17:00 CET
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman and Nobel Prize winners Walter Gilbert and Phillip Sharp , today Biogen has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics. We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor
This press release contains forward-looking statements, including statements relating to the development of and potential benefits, safety and efficacy of the investigational drug, opicinumab, results of certain clinical studies and real-world data. These statements may be identified by words such as “aim,” “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements or the scientific data presented. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Factors which could cause actual results to differ materially from our current expectations include: uncertainty of success in the development of opicinumab, which may be impacted by, among other things, the occurrence of adverse safety events, the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected, unexpected concerns that may arise from additional data or analysis, including data, analysis or results obtained during our clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles such as, among other things, failure to obtain regulatory approvals in certain jurisdictions, failure to protect intellectual property and other proprietary rights, product liability claims, third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
1 As measured by magnetization transfer ratio (MTR) and diffusion tensor imaging-radial diffusivity (DTI-RD).
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Bajaj Electricals Showcases ‘Smart Indoors and Connected Outdoors’ at Light + Building 201819.3.2018 19:00 | Tiedote
Bajaj Electricals Limited, India’s leading player in consumer durables, fans, lighting and engineering projects, participates in world’s leading trade fair Light + Building 2018 at Frankfurt, Germany from March 18th-23rd, 2018. Bajaj Electricals is featuring its smart solutions at Stall D10 in outdoor arena-Agora. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180319005049/en/ Mr. Anant Bajaj, Joint Managing Director, Bajaj Electricals Ltd. (Photo: Business Wire) Based on the key theme of ‘Smart Indoors and Connected Outdoors’, the stall demonstrates the connection between indoors and outdoors through cloud computing. With almost eight decades of experience and expertise in lighting solutions and luminaires, Bajaj Electricals has a host of products exhibited at the trade fair ranging from smart indoor lights for home, commercial and industrial spaces to smart outdoor lights, sensor-based light, smart poles and various integra
Louis Chevrolet Watch Company launches the Chrono-Tour Bitcoin Special Edition19.3.2018 18:00 | Tiedote
Code name: Chrono-Tour Bitcoin Special Edition – Launch: 20/03/2018 – 14.00 GMT This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319005494/en/ (Photo: Louis Chevrolet Swiss Watches) Event! Louis Chevrolet Swiss Watches launches a Swiss Made automatic chronograph dedicated only to Bitcoin owners. An exclusive and limited-edition series to symbolise and affirm the unique sales channel chosen by the brand: its e-commerce store. Each Louis Chevrolet Chrono Tour Bitcoin Special Edition will be Unique Chrono-Tour Bitcoin Special Edition, a well-thought-out stylish design, elegantly bringing the Bitcoin to the forefront. In addition to a specific dial, a Bitcoin logo textured around a printed circuit board will be inserted into the back glass. This gives a technological holographic effect while highlighting the mechanics of the watch. The background will be personalised with a laser and will indicate the purchase price in Bitcoins
New Global Survey Points to Key Issues, Needs and Gaps in Fight to End Smoking19.3.2018 17:00 | Tiedote
The Foundation for a Smoke-Free World released findings today from a global survey to better understand smokers, their experiences, and challenges they face when they try to quit smoking. The survey also highlights their awareness regarding the harm caused by smoking and how their perceptions of cigarettes, alternative products, and nicotine influence their motivation to move away from smoking. The data will shape the development of research to determine the best solutions to accelerate the end of smoking across diverse cultures and economic conditions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319005647/en/ Figure 1: Which of the following situations, if any, apply to you? (% - Top Three Answers per Country) (Graphic: Business Wire) The 2018 State of Smoking Survey included 17,421 current smokers, ex-smokers, and non-smokers from 13 countries: Brazil, France, Greece, India, Israel, Japan, Lebanon, Malawi, New Zealan
New Documentary Raises Global Water Crisis Awareness As 844 Million People Still Lack Access to Clean Drinking Water19.3.2018 16:12 | Tiedote
Procter & Gamble’s (P&G) non-profit Children’s Safe Drinking Water (CSDW) Program and National Geographic are raising awareness about the global water crisis with the release of a new documentary and national survey in conjunction with World Water Day. The documentary, titled “The Power of Clean Water,” follows the lives of three women and their families, providing a first-hand perspective on the daily challenges of accessing clean drinking water. As the film progresses, viewers witness how P&G’s Purifier of Water packets, distributed by partners ChildFund in Indonesia, CARE International in Kenya and World Vision in Mexico, have helped transform these communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319005689/en/ P&G conducted a survey* to understand Americans' level of awareness and concern with the global water crisis and its effects. (Graphic: Business Wire) Global awareness of the water crisis is growing,
If You Previously Purchased or Otherwise Acquired Certain Petrobras Securities, You Could Get a Cash Payment from a Class Action Settlement19.3.2018 16:00 | Tiedote
The following statement is being issued by Pomerantz LLP regarding In re Petrobras Securities Litigation. Important Legal Notice from the United States District Court for the Southern District of New York Two proposed settlements have been reached in a securities class action lawsuit brought by investors against Petróleo Brasileiro S.A. (“Petrobras”) and certain of its affiliates, underwriters, external auditors, and current and former directors and officers. The Settlements include certain securities issued by Petrobras. Petrobras, the Underwriter Defendants, and PricewaterhouseCoopers Auditores Independentes (“PwC Brazil”) deny any and all allegations of wrongdoing, and the District Court has not decided who is right. If you requested exclusion in response to the previously mailed notice of pendency of class action dated May 9, 2016, you are included in this Settlement, and you must request exclusion again if you do not want to be included in the Settlement Class. Am I included in th
YuppTV Awarded Rights for Vivo-IPL 2018 for Australia, Continental Europe and South East Asia19.3.2018 15:30 | Tiedote
As the most awaited event of the year, the Vivo-IPL 2018, which is Season 11 of the world’s biggest T20 tournament, approaches, cricket fans have yet another reason to rejoice! YuppTV, the world’s leading OTT brand for South-Asian content, has announced that it has awarded the exclusive digital & television media rights for Vivo-IPL 2018 by Star India for Europe, South America, South East Asian countries, and non-exclusive rights for Australia. Scheduled to take place from 7 April to 27 May 2018, the Vivo-IPL 2018, the biggest and most eagerly awaited cricketing extravaganza in a decade of IPL history, will witness eight teams playing this season including Chennai Super Kings and Rajasthan Royals that are back in action after serving two years of suspension. With the enormous anticipation and such high stakes in the offing and an exciting line-up of teams, cricket fans the world over have the perfect window to catch every swing and ball of the Vivo-IPL 2018, thanks to the YuppTV app. C
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme