As of November 2019, the HERA clinical trial has been officially re-initiated.
The HERA study was re-initiated after the study was put on hold in 2018 by Regulus Therapeutics for non-safety and non-regulatory reasons. Sanofi has taken over the development of SAR339375 and re-initiated the clinical study after the protocol design was re-assessed and optimized. Sanofi is seeking Alport patients who meet the inclusion criteria in the US, Europe, China and Australia.
The effectiveness and safety of lademirsen (SAR339375), an anti-miR21 compound, is being investigated in a two years study consisting of different periods. In the double-blind period (first year), Sanofi is comparing the investigational drug with a placebo (which looks like the investigational drug, but contains no active medicine). The second year is an open-label period where every patient receives the active investigational medicine. After two years of treatment, there is a 10-week follow-up period.
Patients will have weekly visits, either at the study center or at home. At a minimum, patients will need to visit the study center every 3 months. There will be no cost to the patient while participating in this trial. Travel and lodging will be reimbursed. The investigational drug (and placebo) are provided as an injection under the skin using a small gauge needle. Periodic tests and assessments are to be done, such as blood and urine tests, hearing assessments, ECG, genetic sequencing. Biopsies are not required during the study.
The study is looking for male and female patients who:
· Are 18-55 years of age (inclusive)
· Have a confirmed diagnosis of Alport syndrome
· Have a certain value of kidney filtration rate (eGFR >35 ml/min/1.73m2 and <90 ml/min/1.73m2)
· Have not received a kidney transplant
· Are currently not on dialysis
· Are less than 110kg (242 pounds)
· Do not have diabetes mellitus
More information on this study can be found on the HERA Clinical Trial website and the ClinicalTrials.gov website. As of May 25, 2021, there are five active investigational sites in the United States (Los Angeles, California; Minneapolis, Minnesota; New York City, New York; Cleveland, Ohio; Salt Lake City, Utah). Updated site information will be posted as it becomes available.
ASF invited a medical expert at Sanofi-Genzyme who designed the HERA clinical trial to speak to the larger Alport community about this ongoing study and to answer patients’ questions as part of a webinar held on June 30, 2021. You can watch a closed-captioned recording of the webinar at this link.