Hansa Biopharma has decided to begin the Phase III clinical trial of an antibody-cleaving enzyme, imlifidase, for the treatment of anti-Glomerular Basement Membrane (anti-GBM) disease.
This decision follows a pre-investigational new drug (IND) meeting with the US Food and Drug Administration (FDA).
At the meeting, Hansa had sought advice on the Phase III trial from the FDA, which had indicated alignment with the company’s proposed trial design, including those on the proposed primary and secondary goals, as well as the number of patients to be enrolled.
Before initiating the Phase III trial, Hansa will submit an IND application to the FDA for anti-GBM disease.
The company also expects to receive input and additional feedback from the regulatory body.
Hansa Biopharma chief scientific officer Christian Kjellman said: “The FDA’s valuable insight and guidance at the pre-IND meeting paves the way for Hansa to potentially bring a new treatment to patients with anti-GBM disease, a devastating autoimmune condition.
“The successful outcome of the meeting with the FDA marks an important milestone for Hansa Biopharma’s efforts to develop potentially lifesaving and life-altering therapies for patients with rare immunological diseases where there is a significant unmet medical need.
“Anti-GBM disease is the first IgG-mediated disease outside transplantation where imlifidase has been shown to halt an ongoing autoimmune injury.”
The company has also begun an advice procedure with the European Medicines Agency for the study on anti-GBM disease in the region.
The Phase III clinical trial is expected to enrol 50 patients suffering with anti-GBM disease across Europe and the US, starting next year.
In this trial, the recruited subjects will be randomised and given either imlifidase in combination with standard of care (SoC) or SoC alone.
The primary goal of the trial is to assess patients’ renal function using eGFR at six months.
During a six-month follow-up period, patients will be assessed for other parameters on their kidney function.
The data for a recently completed Phase II study demonstrated that 67% of patients treated with imlifidase achieved dialysis independence status at the six-month period.
In 2018, Imlifidase was given orphan drug designation for anti-GBM disease by the FDA and the European Commission.