18 Nov November 2016 Update on HERA Phase 2 Study
Regulus Therapeutics recently provided an update on the worldwide HERA study on Alport syndrome.
Temporary Pause in Enrollment
As previously communicated by Regulus, the international Phase 2 study RG012-03, also known as the “HERA” study for patients with Alport syndrome, is currently authorized by the United States Food and Drug Administration (FDA) and has been approved by institutional review boards (IRBs) in the US. However, in the process of submitting the study for authorization in other countries, Regulus received feedback from various European regulatory agencies requesting additional information on how the drug works and interacts with the body after repeated injections.
To appropriately respond to this feedback, Regulus has decided to temporarily pause enrollment in the HERA study and start a Phase 1 multiple dose study in healthy volunteers. This study is projected to begin dosing in December 2016.
The decision to pause the HERA study is not the result of any safety concerns regarding the study drug or overall study.
In addition, a number of modifications to the HERA study are currently being considered, including the addition of a 6-month extension to provide active drug to all patients, a reduction in the number of patients from whom kidney biopsies will be required, and modifications to the enrollment process to facilitate study eligibility. We believe these changes will significantly enhance our patients’ experiences in the HERA study.
Regulus understands that the decision to pause the study at this time presents an inconvenience to patients. However, it is important that Regulus appropriately responds to all regulatory requests so that all sites and countries follow the same study protocol.
Enrollment in the HERA study will resume globally in the first half of 2017 once the Phase 1 study is complete.
How is the ATHENA Study Impacted?
During this pause, the ATHENA study will continue to enroll. Please keep in mind that a patient’s participation on ATHENA will be used to assess eligibility for the HERA study and if eligible, patients will have the ability to screen for the HERA study upon reopening.
For more information about the HERA and ATHENA studies or to find a study site near you, please go to www.alportstudy.com.