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Roche Provides Community Update on BMS-986089 (RG6206)

Earlier this year, Bristol-Myers Squibb (BMS) announced it had entered into an agreement to license BMS-986089 (RG6206), an anti-myostatin adnectin in development for Duchenne muscular dystrophy, to Roche. Today, the Roche team has provided an update to our community outlining their transition plan with this therapy, including the progress of their ongoing recruitment for the BMS-986089/RG6206 trial.


We appreciate both BMS and Roche’s transparency during this transition and look forward to continued updates on this trial.


Related Resources:

Community Update from Roche:

Dear Duchenne community,


We at Roche and our U.S. affiliate Genentech are privileged to take on development of BMS-986089. Moving forward this investigational molecule will be called RG6206. Our team is looking forward to partnering with the Duchenne community to make a meaningful difference to young people with Duchenne.


Our immediate priority is to ensure a seamless transition of the development programme. To achieve this we are working in close partnership with BMS. The phase 2/3 study of RG6206 in ambulatory boys with Duchenne is actively recruiting in the US and five boys have been dosed to date. We assure you there will be no impact on participants in the study during the transition from BMS to Roche. We are working closely with the study sites to ensure that study participants have all the information they need to continue participation without interruption.


The following US study sites are currently open for recruitment:

  • Neuromuscular Research Center, Arizona
  • David Geffen School of Medicine UCLA, California
  • University of Florida, Florida
  • Kennedy Krieger Institute, Maryland


Planned US sites include:

  • Stanford University, California
  • University of Kansas Medical Center, Kansas
  • Saint Louis Children's Hospital, Missouri
  • University of California Davis Medical Center, California
  • Cincinnati Children's Hospital Medical Center, Ohio
  • Nemours Children's Hospital, Florida
  • Rush University Medical Center, Illinois
  • University of Iowa, Iowa
  • Children's Hospital of Philadelphia, Pennsylvania
  • Seattle Children's Hospital – Washington
  • Center for Integrative Rare Disease Research (CIRDR), Georgia
  • Las Vegas Clinic, Nevada
  • Nationwide Children's Hospital, Ohio
  • Yale University School of Medicine, Connecticut


Additional countries planned for 2017 and 2018 (pending Regulatory and Ethics approvals) include:


Argentina, Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Spain, Sweden and United Kingdom.


Please visit www.clinicaltrials.gov (using protocol number NCT03039686) and www.clinicaltrialsregister.eu (using EudraCT Number: 2016-001654-18) for up to date information on countries and sites.


We would like to thank all the boys and families who consider taking part in clinical studies; your commitment is helping to advance research in Duchenne.


We look forward to working together with the Duchenne community and sharing more updates about RG6206 in the future.


If you have any questions or would like to discuss this, please reach out to me at sangeeta.jethwa@roche.com Best regards,


Sangeeta Jethwa, MD, on behalf of the Roche Duchenne Muscular Dystrophy team 

Head, Patient Partnership, Rare Diseases 

Roche

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