mirococept (APT070) / Inflazyme - LARVOL DELTA

The EMPIRIKAL-2 Trial: Safety Run Outcomes of Mirococept (APT070) in Deceased-Donor Kidney Transplantation and Transition to the Randomised Controlled Phase Trial (ATC 2026) - "The EMPIRIKAL-2 safety run met the predefined safety objectives and demonstrated good tolerance to all Mirococept doses. No dose-limiting toxicity was identified, and systemic exposure remained transient and within a safe range. These results support progression to the multicentre RCT, where 144 participants will be randomised to the three Mirococept doses or placebo on a 1:1:1:1 basis."

Clinical • Cardiovascular • Nephrology • Reperfusion Injury • Transplant Rejection • Transplantation

EMPIRIKAL-2: Safety run evaluation of Mirococept (APT070), an ex-vivo complement-targeting therapy, in deceased-donor kidney transplantation (ERA 2026) - "The three evaluated doses were well tolerated. These findings support proceeding to the randomised controlled phase of the trial, where selected doses will be compared against placebo to identify the optimal regimen for reducing DGF."

Preclinical • Nephrology • Reperfusion Injury • Transplant Rejection • Transplantation

Multicentre, multi-arm, double-blind randomised placebo-controlled dose-finding trial investigating the safety and Efficacy of MirococePt (APT070) In Reducing delayed graft function In the Kidney ALlograft (EMPIRIKAL-2): study protocol for a randomised controlled trial. (PubMed, BMJ Open) - "Registered on 4 July 2024. 2.0 dated 9 May 2024."

Clinical protocol • Journal • Nephrology • Reperfusion Injury • Transplantation

EMPIRIKAL-2: Efficacy of MirococePt in reducing delayed graft function in the kidney allograft (BTS-NHSBT JAC 2025) - No abstract available

Clinical

Ex vivo delivery of Mirococept: A dose-finding study in pig kidney after showing a low dose is insufficient to reduce delayed graft function in human kidney. (PubMed, Am J Transplant) - "The ex vivo administration of Mirococept is a safe and feasible approach to treat DGF in deceased donor kidney transplantation. The porcine kidney study identified an optimal dose of 80 mg (equivalent to 120 mg in human kidney) that provides a basis for further clinical development."

Journal • Preclinical • Nephrology • Reperfusion Injury • Transplantation

Could Complement Inhibition be a Good Therapeutic Target in Alzheimer’s Disease? (AAIC 2017) - "...  14 month old Tg2576 mice were intravenously injected with Mirococept (APT070), an analogue of the human complement regulator CR1... This pilot project sets up the basis for a rationale towards exploring complement inhibition as a good candidate for therapeutic intervention in the context of neurodegeneration."

Preclinical • Alzheimer's Disease • CNS Disorders