EryDel SpA, a global late-stage biotech company aimed at developing and commercializing therapies for the treatment of rare diseases delivered by its proprietary red blood cell technology, announced the completion of patient enrollment of ATTeST, the Phase 3 pivotal trial in Ataxia Telangiectasia (AT). Topline data from the study are expected at the end of 2020. “This is a significant milestone for the AT community who have collaborated with us in this endeavor” stated Luca Benatti, Ph.D., Chief Executive Officer. “Positive data would enable EryDel to file our first NDA in the second half of 2021 and would represent an important step toward becoming a fully integrated company that can bring innovative therapies to patients.”
“We have completed enrollment of ATTeST, the largest clinical study ever conducted in AT”, said Guenter R. Janhofer, M.D., Ph.D., EryDel's Chief Medical Officer. “We thank all of the patients in this trial and their families, who have sacrificed time and energy to participate in this trial. We are also deeply grateful for the support we have received from investigators and the clinical site staff, as well as for the extensive participation of the patient associations.” Janhofer continued, “following the positive Phase 2 study we hope that the ATTeST trial will confirm the effect of EryDex on improving neurological symptoms and potentially delaying disease progression.”
“Treatment of the neurologic problems associated with AT is paramount to improve the lives of our patients and their families, as there are no treatments known today to slow or stop the neurological decline. Therefore, we look forward to seeing the data from ATTeST, when it becomes available later this year” said Howard Lederman, M.D., Ph.D., Professor of Pediatrics at the Johns Hopkins University School of Medicine, and director of the Ataxia Telangiectasia Clinical Center. Dr. Lederman is an investigator in the ATTeST trial along with 21 other investigators in 11 countries on 5 continents.
For more info:
https://www.erydel.com/uplPdf/erydel-announces-completion-of-patient-enrollment-in-phase-3-attest-trial-the-largest-clinical-study-ever-conducted-in-ataxia-telangiectasia-at.pdf