Medeor gets FDA go-ahead for Phase 3
- San Mateo biotech Medeor Therapeutics has gained clearance from the Food and Drug Administration for a Phase 3 trial of its lead immunotherapy MDR-101, along with a special protocol assessment (SPA) agreement on protocol design, amendments and analysis for the trial in kidney transplant patients.
- The trial, designed to assess the efficacy and safety of the cellular immunotherapy MDR-101 in HLA-matched living donor kidney transplant recipients, with the primary endpoint being functional donor-specific immune tolerance, could begin as early as the second half of this year.
- There were over 79,000 kidney transplants globally in 2014, and over 18,000 in the U.S. alone in 2015. The immunosuppressants market was worth around $5.1 billion in 2014 with kidney transplants responsible for over half of this, and expected to increase.
"The current standard of care to prevent rejection of organ transplants is far from optimal due to unacceptably high long-term failure rates and treatment-associated complications, and new approaches are greatly needed to relieve organ transplant recipients from the litany of undesirable effects associated with anti-rejection drug regimens," said D. Scott Batty, Jr., CMO of Medeor Therapeutics.
Medeor's approach with MDR-101 is to trigger hematologic mixed chimerism, reprogramming the immune system so that it will tolerate both the donors' and recipient's tissue without rejection. This could do away with the need for immunosuppressants, and therefore reduce the need for toxic and long term drug treatment.
"While our first indication is HLA-matched, living donor kidney transplants, the proprietary technology on which MDR-101 is based has the potential for use in all solid organ transplant recipients, regardless of degree of HLA match," said Batty.
The value of the market for immunosuppressants in organ transplant is predicted to fall by 5% between 2014 and 2023, in response to inadequate medical coverage, and high costs. While the cellular therapy approach is still relatively new, and Medeor appears to be the only company in the space, the changes in the market could be an important opportunity for the small biotech.
In a similar approach, researchers at the University of Wisconsin-Madison aim to take stem cells from a kidney donor and infused these into the organ recipient after the transplant, in a project that is moving towards clinical trials.
The first long-term kidney transplant was carried out in Boston in 1954, between two identical twins. While these patients didn't require immunosuppression, the first successful non-twin transplant was in 1959 in the UK, using total body irradiation to suppress the immune system. Kidney transplantation has come on in leaps and bounds since then, with patients living longer and healthier lives and incurring lower health costs, but the long-term use of immunosuppressants can lead to infection, sepsis, post-transplant lymphomas and other side effects.
- Medeor Therapeutics Statement
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