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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
GE’s AffinityTM: The first civil supersonic engine in 55 years – launching a new era of efficient supersonic flight16.10.2018 01:17 | Tiedote
At a press conference with Aerion Corporation today, GE Aviation announced that it has completed the initial design of the first supersonic engine purpose-built for business jets. This new engine class, revealed today as GE’s AffinityTM turbofan, is optimized with proven GE technology for supersonic flight and timed to meet the Aerion AS2 launch. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005961/en/ The name “Affinity” was chosen because it reflects this engine class’ harmonious assemblage of GE’s commercial, non-civil and business aviation propulsion technologies to bring a true step-change in commercial supersonic propulsion. (Photo: Business Wire) The Affinity is a new class of medium bypass ratio engines that provide exceptional and balanced performance across supersonic and subsonic flights. The Affinity integrates a unique blend of proven military supersonic experience, commercial reliability and the most adv
IFF to Release Third Quarter 2018 Results November 515.10.2018 23:15 | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of scent, taste, and nutrition, announced that it will release its third quarter 2018 earnings results following the market close on Monday, November 5, 2018. The management team will host a live webcast on Tuesday, November 6, 2018 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with over 110 manufacturing facilities, 100 R&D centers, and 33,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for
AMPLEXOR to Present on Neural Machine Translation Engine at Artificial Intelligence Event: 30 Years of DFKI – 30 Years of AI for Humans15.10.2018 22:09 | Tiedote
AMPLEXOR: MEDIA ADVISORY: The German Research Center for Artificial Intelligence (DFKI) is one of the largest Artificial Intelligence (AI) centers of excellence globally, and is celebrating the 30th anniversary of its efforts partnering and researching AI for humans with an event, 30 Years of DFKI – 30 Years of AI for Humans. AMPLEXOR is honored to be the only external partner presenting at the event and will join senior researcher from DFKI, Raphael Rubino, to demonstrate AMPLEXOR’s enterprise-grade, neural machine translation (NMT) solution, developed in collaboration with DFKI. The NMT collaboration with DFKI was announced earlier in 2018 to support the translation of content in highly specific and demanding industries, Life Sciences and medical devices. The solution aims to significantly reduce the amount of human intervention to produce professional translation quality and has consistently outperformed customized engines from well-known MT providers. What: AMPLEXOR joins DFKI to c
Lehman Brothers Treasury to Further Explore Strategic Opportunities15.10.2018 19:54 | Tiedote
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that the liquidators of LBT are continuing to explore various strategies to, among other things, facilitate the consolidation of the LBT creditor base and the wind-down of the LBT estate. To that end, the liquidators of LBT intend to engage with certain of LBT’s creditors and other market participants regarding potential strategies, including, but not limited to, a potential sale of a portion of LBT’s assets. No assurances can be made that any strategy will be employed, or if one is employed, the timing of its implementation. LBT does not undertake to publicly update its disclosure to reflect developments in this matter. View source version on businesswire.com: https://www.businesswire.com/news/home/20181015005777/en/ Contact information Kramer Levin Naftalis & Frankel LLP Daniel Eggermann, 212-715-9495
SFL – Third-Quarter 2018 Financial Information15.10.2018 19:28 | Tiedote
Regulatory News: SFL (Paris:FLY): Consolidated revenue by business segment (€000's) 2018 (9 months) 2017 (9 months) Rental income 143,790 147,819 o/w Paris Central Business District 119,038 114,326 Paris Other 22,479 21,526 Western Crescent 2,273 11,967 Other revenue 0 0 Total consolidated revenue 143,790 147,819 At €143.8 million, consolidated rental income for the first nine months of 2018 was down €4.0 million or 2.7% compared to the €147.8 million reported for the same period of 2017. The decline was due to the disposal of the IN/OUT property in September 2017, the effects of which were offset to a significant extent by growth in like-for-like income. On a like-for-like basis (excluding all changes in the portfolio affecting period-on-period comparisons), rental income was €6.0 million (4.6%) higher, reflecting the contribution of new leases signed in 2017 and 2018, mainly in the Washington Plaza, 103 Grenelle, Cézanne Saint-Honoré and 9 Percier properties, as well as an increase i
Hilton Earns #2 Spot as World’s Best Workplace15.10.2018 18:54 | Tiedote
For the third consecutive year, Hilton has been named as one of the World’s Best Workplaces recognized by Great Place to Work®. Hilton climbed seven spots to the highly coveted second spot on the list of the top 25 companies and is the only hospitality company in the top ten. Team Members from the world’s most hospitable company say Hilton’s culture, benefits and travel perks make it a great place for a career. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005711/en/ Hilton President & CEO Chris Nassetta with Team Members. (Photo: Business Wire) “Our Team Members are the heart of our business, and they have been the driving force behind our growth and success around the world for nearly 100 years,” said Christopher J. Nassetta, president & CEO of Hilton. “As the pioneers of hospitality, we are dedicated to creating exceptional experiences for every person we meet - and this starts with our Team Members, who make all o
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