Cerium Investigational Drug Product
Primary Membranous Nephropathy (PMN)
Program
Preclinical
Phase I/II
Phase III
SNP-ACTH (1-39) Gel
Long-acting ACTH treatment for Primary Membranous Nephropathy (PMN) in adults
Results from Treatment
Cerium has formulated a synthetic porcine ACTH drug substance into a subcutaneous injectable drug product (SNP-ACTH [1-39] Gel). Similar to other synthetic long-acting ACTH products containing highly purified synthetic ACTH peptides, a quantifiable number of ACTH molecules present in a long-acting synthetic ACTH drug product is a clear advantage for optimizing the dosing required to achieve strong response rates in PMN.
The Company has completed its preclinical studies confirming the safety and potency of SNP-ACTH (1-39) Gel and a Phase 1 clinical trial in healthy subjects which further demonstrated its safety and tolerability. Cerium has engaged with the FDA on its phase 3 trial design and outcome measures for a prospective, randomized superiority trial to determine if SNP-ACTH (1-39) Gel is superior to Rituximab in inducing a durable remission of proteinuria as a first-line immunosuppressive treatment of moderate to high risk PMN patients. Cerium is currently enrolling patients in its Phase 3 clinical trial.
Published Data
There is a large body of published data showing that melanocortins, a class of peptides that includes ACTH, have distinct and organ-dependent nonsteroidogenic actions that likely mediate the physiologic activity and clinical benefit observed upon ACTH administration in a number of disorders, including glomerular disorders (Gong 2011, Gong 2014, Lindskog et al. 2010, Si et al. 2013, Qiao et al. 2016).
kidney specific evidence
Along with the recent kidney specific evidence showing that MC1R activity leads to stabilization of the actin cytoskeleton in the podocyte of the kidneys (Bergwall et al. 2018), the overall immunomodulatory effect from the melanocortin activity (nonsteroidogenic pathway), combined with its steroidogenic effects, makes Cerium’s SNP-ACTH (1-39) Gel a potentially valuable drug candidate for PMN, and are consistent with published clinical data highlighting the potential efficacy of long-acting synthetic ACTH therapies.
