Ra Pharmaceuticals has started dosing patients in a Phase lb clinical trial assessing RA101495 SC in patients with renal impairment.
The multi-centre, open-label trial is designed to evaluate and compare the pharmacokinetics (PK) profile of RA101495 SC in patients with renal impairment with subjects with normal renal function.
The trial expects to enrol around 16 subjects, including eight patients with severe renal impairment and another eight healthy control subjects with normal renal function.
During the trial, each patient will be given a single, SC dose of 0.3mg/kg of RA101495.
The trial eventually aims to assess RA101495 SC in complement-mediated renal diseases, including atypical hemolytic uremic disorder (aHUS) and lupus nephritis (LN).
Ra Pharmaceuticals president and CEO Doug Treco said: “The initiation of dosing in this Phase lb trial is a meaningful step for advancing RA101495 in multiple complement-mediated renal indications.
“The convenient, once-daily, SC, self-administration dosing profile of RA101495 provides a compelling alternative to currently available, intravenously-administered (IV) therapies, and we continue to work toward providing a differentiated treatment option for these patients and addressing this significant unmet need.”
Ra Pharmaceuticals is currently developing RA101495 as a new, subcutaneously-administered (SC) inhibitor of complement component 5 (C5).
The company is also investigating RA101495 SC under a Phase ll clinical trial for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and generalised myasthenia gravis (gMG).