Talaris stops 2 kidney transplant trials of cell therapy FCR001 in dcSSc
But company to keep recruiting for Phase 2 FREEDOM-3 study
Talaris Therapeutics plans to continue to recruit people with rapidly progressing diffuse cutaneous systemic sclerosis (dcSSc) at risk for organ failure into FREEDOM-3, a Phase 2 clinical study of its investigational cell therapy FCR001.
That’s in spite of the company’s decision to put a stop to its FREEDOM-1 and FREEDOM-2 trials, whose goal was to test the therapy for its ability to keep the immune system from mounting a response against a kidney transplant.
According to Talaris, the decision comes on the heels of a slow-paced enrollment that would prevent the company from catching up on critical milestones, even with early data showing FCR001 may be able to bring about immune tolerance in people who are having a kidney transplant.
“It was an exceptionally difficult decision to discontinue further development of FCR001 in kidney transplantation tolerance despite the promising early data,” Scott Requadt, Talaris’ CEO, said in a company press release.
“I want to express our sincere thanks, first and foremost, to our patients and their donors, as well as to our investigators and collaborators for their participation in this effort, and hope to see continued improvements in kidney disease care in the future,” Requadt added.
Talaris cites ‘promising early data’ despite trials stop
FREEDOM-3 is now enrolling up to 18 adults with dcSSc, ages 18-69, at the University of Michigan in Ann Arbor.
Those interested in participating can contact the trial’s clinical operations site by phone at (617) 655-7551 or via email at [email protected] They also can find out if they’re a good fit for the study by answering a few questions on the study’s website.
Scleroderma occurs when an autoreactive immune system cause hardening and fibrosis — thickening or scarring — of the skin. Sometimes, scleroderma also affects internal organs.
People with dcSSc are more likely to have widespread skin fibrosis and experience symptoms that worsen more quickly than other scleroderma patients. These individuals also are at higher risk of developing internal organ damage.
“While we are disappointed that our work in kidney transplantation will not continue, given the potential of FCR001 to induce durable tolerance, we intend to continue its evaluation for scleroderma, which remains a very high unmet medical need for which there are limited treatment options,” Requadt said.
FCR001 is an allogeneic cell therapy, which means it uses stem and blood cells obtained from a donor. The therapy is given as a single infusion after recipients go through mobilization, a procedure that stimulates stem cells in the bone marrow to enter the bloodstream. Recipients also undergo conditioning, used to suppress the immune system and make room for the new cells, and apheresis, a procedure that that separates blood components.
While we are disappointed that our work in kidney transplantation will not continue, given the potential of FCR001 to induce durable tolerance, we intend to continue its evaluation for scleroderma, which remains a very high unmet medical need for which there are limited treatment options.
According to Talaris, the therapy has the potential to restore immune tolerance by getting rid of any autoreactive immune cells and feeding the body with a healthy supply of immune cells. Such treatment would be expected to halt the immune attack on the body’s tissues.
FREEDOM-3 is an open-label study that’s been launched to evaluate how safe and well tolerated FCR001 is, and how well it may work in people with dcSSc.
It’s expected to last for about five years, and each participant will visit the clinic at least 21 times. Some of these visits may occur at the same time as routine clinic visits and care, while others may take place at home.