Roche/Genentech has provided an update to the community announcing that enrollment in the SPITFIRE pivotal study has been officially completed globally at 48 sites across the US, Canada, Argentina, Europe, Australia and Japan.

Read Roche/Genentech’s letter to the community:

Dear Duchenne community,

It was wonderful to see many members of the community at the Parent Project Muscular Dystrophy (PPMD} Conference at the end of June in Orlando, Florida, USA. At the conference, on 29 June 2019, we provided an update on the Roche/Genentech anti-myostatin (RG6206} clinical program. RG6206 is an adnectin fusion protein designed to bind to a protein called myostatin and potentially inhibit its function. RG6206 is currently under investigation to evaluate its efficacy, safety and tolerability in ambulatory boys with Duchenne Muscular Dystrophy. With this letter, we are pleased to update the broader community.

As of 3rd July 2019, enrollment in the WN40227 {SPITFIRE} pivotal study has been officially completed globally at 48 sites across the US, Canada, Argentina, Europe, Australia and Japan. A total of 166 boys with Duchenne between the ages of 6 and 11 were randomized. The list of clinical sites as well as study details can be found at www.clinicaltrials.gov (reference NCT03039686, Roche study WN40227}.

As with all our clinical research programs, we continue to monitor our studies to confirm they should continue as planned; as such, we will be reviewing the ongoing SPITFIRE study in October-November of this year. This review is specified per the study protocol and is not prompted by any event or monitoring trends. We will update the community after the review is complete.

As the study is an ongoing placebo-controlled trial, it is important the study remain blind to preserve its integrity. As long as the study is continuing, no data can be shared.

We are sincerely grateful for the continuous partnership of the Duchenne community and would like to thank all of our study participants and their families and caregivers.
Roche/Genentech is committed to working together with the Duchenne community to support the evolving needs of patients and their families.

• If you have any questions regarding your ongoing participation in the SPITFIRE study, please contact your study physician.
• For more information on the ongoing SPITFIRE study please reach out to us via e-mail at genentech@medical-information.com or by phone at +1 888 662 6728.

Warm regards,

Elena Zhuravleva, Patient Partnership Director, Rare Disease, Roche, Switzerland On behalf of the Roche/ Genentech Duchenne team

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