Pfizer Inc. announced on August 30, 2018 that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD). Yesterday, ROCHE released a letter stating why Pfizer’s termination of domagrozumab does not affect ROCHE’s ant-myostatin trial.
13 September 2018
Dear Duchenne community,
By now, many have heard about Pfizer’s decision to stop their clinical studies of domagrozumab in Duchenne Muscular Dystrophy1. We have received questions as to whether Pfizer’s decision has an impact on our clinical development program of RG6206 in Duchenne.
RG6206 is an investigational anti-myostatin adnectin that is designed to block the activity of myostatin and is given subcutaneously (by injection under the skin). The safety and efficacy of RG6206 in ambulatory boys (6-11 years old) is being evaluated in the Phase 2/3 SPITFIRE clinical study (www.clinicaltrials.gov reference NCT03039686, Roche study WN40227). Enrollment in the SPITFIRE clinical study is ongoing globally, and there are no planned changes to the study or its timelines as a result of Pfizer’s recent decision.
When evaluating investigational therapies, individual clinical studies are designed to address questions of safety and/or efficacy in a way that is specific and unique to the investigational molecule being studied. This means that studies with different study designs cannot be easily or directly compared. As such, it is not possible to draw comparisons or conclusions about RG6206 based on studies of other molecules with different study designs.
We are very grateful and appreciate the continuous partnership of the Duchenne community and would like to extend our thanks to all study participants and their families.
If you have questions:
Regarding your ongoing participation in the SPITFIRE study, or if you are in the screening phase, please contact your study physician.
If you are not in the SPITFIRE study, but have questions about RG6206, please contact me at firstname.lastname@example.org.
Elena Zhuravleva, MD, PhD on behalf of the Roche Duchenne team
Patient Partnership Director, Rare Disease, Roche, Switzerland