GlobeNewswire

Roche provides update on tominersen programme in manifest Huntington’s disease

Share
  • Dosing to stop in Phase III clinical study of tominersen following recommendation from an Independent Data Monitoring Committee (iDMC)
  • No new safety signals were identified for tominersen in the iDMC’s review


Basel, 22 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). The iDMC made its recommendation based on the investigational therapy’s potential benefit/risk profile for study participants. No new or emerging safety signals were identified for tominersen in the review of the data from this study. Roche intends to continue following participants for safety and clinical outcomes, without the dosing of the investigational medicine or placebo. Once full data from the Phase III study are available and analysed, Roche will share learnings and future plans with the HD community.

Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study.

“This is very unfortunate news to deliver on the tominersen Phase III study and we know it will be especially difficult for people with Huntington’s disease to hear. The HD community currently has no treatments to stop or slow the progression of this rare neurodegenerative disease that impacts families across generations.” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “GENERATION HD1 is the largest clinical trial in Huntington’s disease to date and we do know that the data generated will significantly advance our understanding of huntingtin-lowering as a potential treatment approach. We would like to thank all of the individuals and families participating in the study for their contribution, as well as the broader HD community for their commitment and collaboration.”

The Phase I PK/PD study (GEN-PEAK) of tominersen and the observational Roche HD Natural History Study will continue.

About tominersen and the clinical trials
Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals.

Tominersen is being investigated in HD in the following clinical studies:

  • GENERATION HD1: a randomised, multicenter, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of treatment with tominersen in people with manifest HD over 25 months. Study participants were randomised to either 120 mg every-2-months or 120 mg every-4-months intrathecal injections of tominersen, or placebo. The study has recruited 791 participants from 18 countries around the world.
  • GEN-EXTEND: an open label extension study for participants coming from any Roche HD study. Participants receive 120mg tominersen every-2-months or every-4-months in the study.
  • GEN-PEAK: a Phase I study aiming to better understand the pharmacokinetics of tominersen and how tominersen affects mHTT levels and other markers in the spinal fluid and blood, which studies a range of doses from 30 mg to 120 mg of tominersen over two administrations.

About Huntington’s disease
Huntington’s disease is a rare genetic, progressive condition that causes the nerve cells in the brain to break down, causing problems with a person’s ability to think, move and function, leading to increasing disability and loss of independence. It has a devastating impact on people living with the disease, and the hereditary nature of HD means it profoundly affects entire families for generations. Survival ranges from approximately 10-20 years following motor onset of the disease. There is no known cure for HD and no approved therapies that treat the underlying cause.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17

Patrick Barth
Phone: +41 61 688 44 86
Dr. Daniel Grotzky
Phone: +41 61 688 31 10

Karsten Kleine
Phone: +41 61 682 28 31
Nina Mählitz
Phone: +41 79 327 54 74

Nathalie Meetz
Phone: +41 61 687 43 05
Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67


Roche Investor Relations
Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com

Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Dr. Lisa Tuomi
Phone: +1 650 467 8737
e-mail: tuomi.lisa@gene.com

Attachment


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire 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

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Chief Executive Officer12.4.2021 18:46:17 CEST | Press release

The Board of Golar LNG has today received a resignation notice from its CEO Iain Ross. The contractual termination period is 6 months however the final duration can be prolonged or reduced upon mutual agreement. Golar LNG is currently in the final stages of closing the announced sale of its 50% interest in Hygo Energy Transition Limited (“Hygo”) and 32% interest in Golar LNG Partners LP (“GMLP”) to New Fortress Energy Inc. (“NFE”) for a total enterprise value consideration for the two companies of approximately USD 5 billion. The NFE transactions will simplify the Golar group structure, crystalize underlying value and strengthen the balance sheet. The majority of the closing conditions have been completed, including prepayment notices issued to several of GMLPs lenders. Closing of the transactions is expected shortly. The Board of Golar LNG will immediately start the process to recruit Mr. Ross’s successor. Forward-Looking Statements This press release contains forward-looking statemen

Agfa-Gevaert: Share buyback program – regulated information12.4.2021 17:40:00 CEST | Press release

Mortsel, Belgium – April 12, 2021 – 5:40 p.m. CET Within the framework of the share buyback program which was announced in the press release of March 10, 2021, Agfa-Gevaert NV proceeded with the purchase of own shares on the market of Euronext Brussels. The authorization to acquire own shares was granted to the Board of Directors by the Extraordinary General Meeting of Shareholders of May 12, 2020. Agfa-Gevaert NV has requested a financial intermediary to repurchase Agfa-Gevaert shares for a maximum amount of 50.000.000 Euro on its behalf under the terms of an initial discretionary mandate agreement with validity until 31 March 2022, effective as from 1 April 2021. On April 9, 2021, the Agfa-Gevaert Group held 246,467 own shares, which represents 0,15% of the total number of shares of the Group. Detailed operations per day: DateNumber of sharesAverage price (€)Minimum price (€)Maximum price (€)Total price (€)April 1, 202154,7174.01983.96504.1500219,951.40April 6, 202128,4684.01933.9950

NOVA Chemicals Surpasses 65% Completion of its Growth Projects in Ontario, Targets 2022 Start-Up12.4.2021 17:00:00 CEST | Press release

Canadian innovation brings new premium-value, polyethylene resins for recyclable packaging to North American and global markets; The combined projects represent an investment of approximately $2.5 billion (CAD) in the community; Early equipment has been put in service; start-up will commence in late 2022 Sarnia, Ontario, April 12, 2021 (GLOBE NEWSWIRE) -- NOVA Chemicals Corporation, 1000 Seventh Avenue S.W., Calgary, Alberta, Canada T2P 5L5 www.novachemicals.com | 403.750.3600 tel | 403.269.7410 fax NOVA Chemicals Corporation (“NOVA Chemicals”) today announced its second Advanced SCLAIRTECH™ technology (AST) unit and the third phase of the Corunna Cracker Expansion Project have each safely surpassed 65% completion. The first of eight electrical substations were safely energized in March, and the company estimates that both projects will commence full start-up activities in late 2022, after the Corunna Site turnaround which is targeted for spring 2022. The new AST polyethylene unit, loc