SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Medeor Therapeutics, Inc., a clinical-stage company dedicated to the development and commercialization of immunotherapies for transplantation, today announced that the U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to MDR-101, Medeor’s therapy designed to enable immune tolerance in kidney transplant patients, thereby eliminating the need for chronic immunosuppressive therapies.
The RMAT program was developed under the 21st Century Cures Act in order to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious condition.
“This important designation underscores the tremendous unmet medical need for alternatives to today’s immunosuppressive therapies for transplantation,” said Giovanni Ferrara, President and CEO of Medeor Therapeutics. "We have the potential to help people live longer, healthier lives without the need for high dose and chronic immunosuppression and we thank the FDA for this designation that will assist us progressing as efficiently as possible toward a commercially available product.”
The current standard of care for kidney transplants is a lifelong regimen of immunosuppressive drugs in order to avoid organ rejection. While critical for survival, these immunosuppressants and the ensuing chronic immunosuppression are accompanied by long-term unwanted effects, the most significant of which are increased risk of infections and malignancies, as well as onset of metabolic diseases. Overall, despite compliance to the strict regimen of immunosuppressive drugs, 30 to 50% of transplants still fail after only a decade.
MDR-101 is being developed to avert transplant kidney rejection by the recipient’s immune system without the need for chronic use of immunosuppressive drugs. The treatment uses the organ donor’s immune cells transfused into the organ recipient to create a mixed chimeric immune state in the recipient – a continued co-existence of donor and recipient cells in the recipient.
The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. Additional information on the study can be found at ClinicalTrials.gov.
About Medeor Therapeutics, Inc.
Medeor Therapeutics is working to improve the lives of transplant patients by eliminating or reducing the need for a life-long regimen of immunosuppressant medications and their potential life-threatening side effects. Medeor’s Phase 3 clinical study is demonstrating the significant opportunities of this one-time therapy. For more information, visit www.medeortx.com