Research & Development
Hansa Medical's receives Fast Track Designation from US FDA for Imlifidase for transplantation
18 October 2018 -

Hansa Medical AB (STO:HMED), a biopharmaceutical company focusing on inhibition of immunoglobulin G (IgG) -mediated immunopathologies, announced on Wednesday the grant by the US Food and Drug Administration (FDA) of Fast Track Designation to imlifidase for the investigation of imlifidase for transplantation.

Imlifidase (IdeS) is an enzyme in late-stage clinical development that specifically cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response.

According to Hansa Medical, it is initially developing imlifidase as a proprietary treatment to enable kidney transplantation in sensitised patients previously unable to undergo transplant surgery due to the presence of donor-specific antibodies (DSAs).

Imlifidase is being evaluated in a phase 2 study in anti-GBM antibody disease, a rare and acute autoimmune disorder, and imlifidase has potential applications in other solid organ transplants and in a variety of additional acute autoimmune indications.

The company added that it continues to actively engage with the regulatory agencies and anticipate submitting a Biologic License Application (BLA), as well as a Marketing Authorisation Application (MAA), in either Q4 2018 or Q1 2019.

Reportedly, the imlifidase Fast Track Designation is supported by efficacy data reported from four successfully completed phase 2 studies that demonstrate imlifidase's ability to rapidly and significantly reduce Donor Specific Antibodies (DSAs), thereby enabling kidney transplantation.

The FDA's Fast Track programme is designed to facilitate the development and expedite the review of new drugs to treat serious or life-threatening conditions that demonstrate the potential to address an unmet medical need. Fast Track designation provides a company more frequent communication with the FDA regarding the investigational drug's development plan and also provides eligibility for priority review if certain criteria are met.

Hansa Medical is developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases.