Hansa Biopharma ((SE:HNSA)) announced an update on their ongoing clinical study.
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Hansa Biopharma’s recent clinical study, officially titled An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC, aims to assess the renal function in highly sensitized kidney transplant patients one year after desensitization with Imlifidase. The study is significant as it explores a potential solution for patients facing challenges in finding compatible kidney donors due to high sensitization levels.
The intervention being tested is Imlifidase, an enzyme that degrades immunoglobulin G (IgG) antibodies, potentially reducing antibody-mediated rejection risks in transplant patients. This treatment is compared to the best available treatment, which includes various desensitization protocols such as plasma exchange and intravenous immunoglobulin.
The study follows a randomized, open-label, parallel assignment design with no masking. Its primary purpose is treatment-focused, aiming to evaluate the effectiveness of Imlifidase in improving kidney function post-transplantation.
The study began on October 14, 2021, with primary completion and estimated completion dates not specified. The last update was submitted on July 15, 2025, indicating ongoing progress and data collection.
This study update could influence Hansa Biopharma’s stock performance positively if results show improved outcomes for transplant patients, potentially increasing investor confidence. The findings may also impact the competitive landscape in the biopharmaceutical industry, particularly in the field of organ transplantation.
The study is ongoing, with further details available on the ClinicalTrials portal.