Swedish biopharmaceutical firm Hansa Medical has begun dosing patients in its Phase II clinical trial of drug candidate IgG degrading enzyme of Streptococcus pyogenes (IdeS), to treat patients with severe anti-GBM antibody disease / Goodpasture’s disease.
IdeS is currently being developed to allow kidney transplantation in sensitised patients and is said to quickly and effectively reduce IgG antibodies.
The investigator-initiated, open-label Phase II trial will evaluate the safety and tolerability of IdeS in 15 patients on standard care with pulse methylprednisolonene, oral prednisolone and intravenous cyclophosphamide (CYC) in combination with plasma exchange (PLEX).
The efficacy of the drug candidate will be further examined through analysis of renal function at six months post-treatment.
Set to be conducted at 15 clinical sites in Europe, the Phase II trial will be led by Linköping University Hospital professor Mårten Segelmark.
Efficacy data reported from three prior Phase II trials of IdeS demonstrated a rapid and significant decrease in anti-HLA antibodies, facilitating transplantation in patients who previously could not undergo the surgery because of the presence of anti-HLA IgG antibodies.
The drug candidate is being further assessed in a multi-centre clinical trial in the US in highly sensitised patients who did not respond to existing desensitisation methods.
The results from the US trial are expected to be available next year.
It is expected that aside from transplantation, IdeS has applications in other solid organ transplants and various autoimmune diseases.
