Auritec Pharmaceuticals has completed patient enrolment in its Phase I trial to evaluate the safety and pharmacokinetic (PK) of sustained-release tacrolimus (SR-TAC) for the treatment of organ transplant rejection.
An estimated 250,000 to 500,000 people worldwide live with solid organ transplants requiring immunosuppression, with more than 100,000 transplants conducted worldwide every year.
The single-center, open-label, first-in-human, single group assignment trial has enrolled eight healthy participants aged between 18 and 45.
Patients will receive a single dose of 0.1mg/kg SR-TAC by subcutaneous injection and will be followed for up to 60 days.
The trial’s primary endpoints include treatment-emergent adverse events and individual blood concentration-time curve Cmax.
Its short-term general investigational plan is to assess SR-TAC in the enrolled subjects for up to 30 days to determine safety and drug concentrations in blood.
Auritec Pharmaceuticals CEO Dr Thomas Smith said: “The results from this study will inform the long-term goal of this programme, which is to provide an improved treatment modality for prophylaxis of organ (kidney, liver, and heart) transplant rejection with the additional benefit of enhancing medication compliance.
“These improvements have the potential to mitigate both the personal and economic burden of this disease.
“Subsequent trials could lead to a product that improves adherence and reduces toxicity in transplant recipients.”
Auritec’s SR-TAC features tacrolimus monohydrate coated with a biocompatible polymer to extend drug release. It has the potential to treat autoimmune diseases such as psoriasis.