Omeros has announced that the activation of clinical trial sites for patient enrolment is now in progress for its Phase III programme of the human monoclonal antibody zaltenibart for treating paroxysmal nocturnal haemoglobinuria (PNH).
Also known as OMS906, Zaltenibart is an investigational mannan-binding lectin-associated serine protease-3 (MASP-3) inhibitor.
Go deeper with GlobalData
The Phase III programme will involve 120 clinical investigative sites across 30 nations, with a significant number already having detected potential PNH patient participants.
Omeros is actively working with these sites to further identify eligible subjects for the trials of the antibody.
The data required for the biologics licencing application (BLA) and worldwide approval dossiers are underway for the fourth quarter of 2026.
The Phase III trials are set to assess the antibody’s intravenous form dosed one time for every eight-week period.
Omeros’ comprehensive Phase III programme comprises two clinical trials: one for subjects not on complement-inhibitor treatment at study entry and another for those without an adequate response to complement component 5 (C5) inhibitors, ravulizumab or eculizumab treatment.
These two trials are designed to compare the antibody’s safety and efficacy as a single agent against these C5 inhibitors, with regulatory approval received from both the Food and Drug Administration (FDA) and European authorities for the trial designs.
Omeros has already manufactured the antibody-drug product needed for the Phase III programme and has sourced the necessary comparator C5 inhibitors.
The head-to-head study designs aim to show the antibody’s “superiority” over C5 inhibitors.
Omeros Corporation CEO and chairman Gregory Demopulos said: “All of us at Omeros are pleased that the Phase III clinical programme for zaltenibart is well underway.
“The zaltenibart Phase II data have demonstrated important differentiators from currently marketed agents, and we expect those same advantages to be evidenced in the Phase III trials, which are similar in design to our Phase II trials.”
In a move to prepare for the commercialisation of the antibody, the German Federal Joint Committee, a decision-making body, provided recommendations on patient-reported-outcome measures.
These recommendations have been “incorporated” into the antibody’s Phase III design, which could be instrumental in achieving appropriate pricing.
