Sydney-based Cellmid (ASX:CDY) has announced positive efficacy results from its lead anti-midkine antibody, CAB102, in the rare kidney disease, FSGS.
The study performed at the Westmead Institute confirmed previous findings that blocking midkine alleviates damage to the kidney and prevents ensuing defects in renal function. It also demonstrated a humanised antibody targeting midkine, CAB102, is equally as effective as its murine precursor.
The company said demonstrating efficacy of the humanised midkine antibody in the rare kidney disorder FSGS enables it to apply to the US FDA and European EMA for Orphan Drug Designation.
Midkine has been identified as a contributor in several kidney disorders and blocking the action of midkine has previously been shown to improve disease outcomes in animal models. In previous studies, it was shown that Cellmid’s murine antibody, IP14, preserved renal structure and function (ASX announcement, 18 January 2017).
CAB102 represents the humanised form of the murine antibody and has been developed to pre-GMP quality.
Cellmid received an Australian Government DIIS Innovation Connection Grant to support research projects carried out in the laboratories of Associate Professor Vincent Lee at the Westmead Institute.
The collaboration enabled the testing of Cellmid’s lead antibody assets in a complex preclinical rodent model. It provided proof-of-concept that blocking midkine in this manner could protect the kidney from injury in FSGS patients.
The benefits of Orphan Drug status include tax credits for costs of clinical trials, fee waiver and eligibility for seven years of marketing exclusivity.
“We are excited that engagement with some of the leading renal clinicians and researchers in the field of CKD globally has lead us one step closer to clinical deployment of our anti-midkine assets,” said Cellmid’s CEO Maria Halasz.