Talaris Therapeutics has initiated the phase 3 FREEDOM-1 clinical trial to evaluate its investigational, allogeneic cell therapy FCR001 in living donor kidney transplant (LDKT) recipients.
The late-stage clinical trial will assess the safety and efficacy of a single dose of FCR001. The investigational cell therapy has been designed to free LDKT recipients from immunosuppression suppression of the immune response without rejection of their transplanted organ.
The FREEDOM-1 clinical trial will compare FCR001 to tacrolimus and mycophenolate-based standard of care regimen for LDKT recipients. The phase 3 clinical trial is likely to feature 120 adult LDKT recipients at various sites across the US.
The primary endpoint of the FREEDOM-1 clinical trial is the proportion of LDKT recipients, who are free from immunosuppression at 24 months after having a kidney transplant. The FREEDOM-1 trial will also assess the safety of FCR001 donors.
Talaris Therapeutics said that the phase 3 clinical trial for FCR001 has started enrolling patients at the Northwestern Memorial Hospital – its first clinical site, while additional trial sites will be disclosed in the coming months.
Commenting on the FREEDOM-1 clinical trial, Scott Requadt – CEO of Talaris Therapeutics said: “Living donor kidney transplants save lives. However, they have a downside: the lifelong regimen of immunosuppressive drugs that organ transplant recipients must take elevates their risks of hypertension, high cholesterol, type 2 diabetes, sleep and CNS disorders, infections and certain cancers. Moreover, immunosuppressive drugs are, themselves, toxic to the kidney, leading to declining kidney function over time.
“On average, a transplanted kidney only lasts between 12-15 years, and many kidney transplant recipients will require multiple transplants over their lifetime.”
Talaris Therapeutics said that a phase 2 clinical trial of FCR001 saw 26 of 37 LDKT recipients of the investigational cell therapy were able to be weaned off all immunosuppression treatments, with 100% durability so far.
Joseph R. Leventhal – a principal investigator for FCR001 phase 2 and phase 3 trials, commenting on the FREEDOM-1 clinical trial, said: “Transplant surgeons have for decades searched for a way to establish durable immune tolerance to a donated organ, due to the risks and lifestyle limitations imposed by immunosuppression therapy.
“FCR001 has shown great promise toward achieving this goal, with all tolerized patients in the Phase 2 study remaining off immunosuppression. It’s gratifying as a physician to be part of a clinical trial for a therapy that has the potential to change the landscape of living donor kidney transplants and, importantly, improve outcomes for patients.”
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