Business Wire

Biogen Announces AFFINITY Phase 2 Trial Initiation for Opicinumab (Anti-LINGO-1) in Multiple Sclerosis

Jaa

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

About Biogen
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).

Contact information

Biogen
MEDIA CONTACT:
Lindsey Smith, +1-781-464-3260
public.affairs@biogen.com
or
INVESTOR CONTACT:
Ben Strain, +1-781-464-2442
IR@biogen.com

Tietoja julkaisijasta

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, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Tradeshift Announces Q2 2018 Results19.7.2018 14:00Tiedote

Tradeshift, the leader in supply chain payments and marketplaces, today announced results from the second quarter of 2018, showing significant momentum across the company. Tradeshift’s second quarter growth stats announced today include: YoY new bookings grew 315% YoY gross merchandise volume (GMV) grew 350% Largest deal in the quarter was $18.6M Tradeshift’s customer roster showed remarkable growth this quarter, adding 38 new customers, including several Fortune 500 companies such as one of the world’s leading innovators in materials science, the endurance challenge event leader, and the world’s leading platform for clinical development, commercial and real-world data analytics. “It’s amazing to see our strategy work across all areas of our business,” said Christian Lanng, CEO and co-founder of Tradeshift. “We took a big bet that the industry was ready for innovation, and we’re proud that some of the largest companies in the world are now part of the momentum we’re seeing across every

JPMorgan Chase Bank announces the initial exchange price for the cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202019.7.2018 13:58Tiedote

NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. Following the placement on 17 July 2018, JPMorgan Chase Bank, N.A. today announces the initial exchange price of the cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million, referable to H-shares of Ping An Insurance (Group) Company of China Limited (the “Shares”). The initial exchange price of the Bonds has been set at HKD82.1720, representing a 16% premium over the share reference price of HKD70.8379, which was determined in the manner described in the press announcements released on 17 July 2018. Settlement and delivery of the Bonds is expected to take place on 20 July 2018. The Bonds are expected to be rated “Aa3

CORRECTING and REPLACING Connected Objects: a Global Ambition at Total19.7.2018 13:37Tiedote

Please replace the release dated July 10, 2018 with the following corrected version due to multiple revisions. The corrected release reads: CONNECTED OBJECTS: A GLOBAL AMBITION AT TOTAL Total has joined forces with Sigfox, the world’s leading IoT connectivity service, to deploy a solution designed to optimise rolling stock and help manage trailer fleets. What’s the solution? Created by transporters, for transporters, Where’s my Trailer? is an innovative new way to improve how trailer fleets are used and kept secure. The solution works by installing a box on the trailer, to identify any equipment that is underused or has been lost or stolen. Our partnership The solution was developed by Total Marketing France through its subsidiary Stela and has been in test phase for a year with the company’s transporter customers. “Sigfox technology, together with our proximity to Freight and Logistics, has given us the opportunity to offer a reliable and efficient way of geolocalising rolling stock t

FlipNpik Opens Its Private Sale to Public and Introduces Fiat-Based Payment Gateway19.7.2018 11:00Tiedote

In an unprecedented move, FlipNpik, the blockchain-powered social media platform for local businesses, democratises its private sale and allows everyone to enjoy the privileges and bonuses traditionally reserved only for the large investors. Known as 'whales', these powerful investors typically enjoy large bonuses during the private sale phase of ICOs (Initial Coin Offerings). FlipNpik now turns this practice on its head by eliminating the large investment required to benefit from the 'whale' bonus, which offers up to 100% bonus of FNP (FlipNpik) tokens to the public, leveling the playing field for small investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180719005283/en/ Monetize your social media posts by supporting local shops (Graphic: Business Wire) Deploying one of the first fiat-based payment gateways using money transfers to facilitate ICO payments, FlipNpik also allows the larger community who may be new to bu

Pat Johnson Joins UniPrint Team in Europe19.7.2018 10:35Tiedote

UniPrint.net announced today that Pat Johnson has joined the company to support and develop their EMEA Partner Program, as well as with the promotion of their highly successful Cloud solutions UniPrint Infinity™ and ePRINTit™. Pat brings with him 20 years of experience at Xerox UK where he was instrumental in engaging with software vendors to support Xerox Connectkey products and Xerox Business Partner Channels. In joining UniPrint.net, Pat is well placed to support the continued growth of UniPrint.net EMEA Partners with the UniPrint product portfolio. Pat will hold the new position of MPS Partner & Strategy Manager EMEA, continuing UniPrint’s success in engaging valued business partners towards a modern approach for Software as a Service (SaaS) and Cloud printing solutions. Pat comments: “I am excited to start a new challenge within UniPrint.net and I look forward to working with the EMEA team to further develop their Partner Program. I am fortunate to be joining a respected company w

The Poseidon Foundation: Liverpool Bids to Be First ‘Climate Positive’ City by End of 202019.7.2018 10:34Tiedote

The Poseidon Foundation (“Poseidon”) have signed a ground-breaking partnership with Liverpool City Council in a bid to make Liverpool the world’s first climate positive city by the end of 2020. The city council has signed an agreement with Poseidon to integrate its ground-breaking blockchain-powered platform into Liverpool’s day to day operations. Poseidon’s technology offsets the carbon impact of any product or service by transparently supporting essential forest conservation projects, allowing individuals, organisations and governments to reverse the impact of climate change every day through their activities. Poseidon will be moving its operations to the city in order to play a key role in Liverpool’s new climate positive strategy, which will be trialled over the next 12 months. Poseidon, who are already working closely with Liverpool company BAC Mono to create the world’ first climate positive car, will work with local schools, universities and businesses to develop educational pro

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