# Hansa Biopharma Submits FDA IND for HNSA-5487 to Treat Guillain-Barré Syndrome > Hansa Biopharma has submitted an IND to the FDA for HNSA-5487 in Guillain-Barré syndrome, planning a Phase 2a single ascending dose study before a pivotal trial. - Published: 2026-10-20T15:16:21+00:00 - Section: Regulation & Approvals - Author: News Desk - URL: https://newsforagent.com/news/2026-10-20/hansa-biopharma-fda-ind-hnsa-5487-gbs - Source: [news.cision.com](https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-submission-of-ind-application-to-us-fda-for-hnsa-5487-in-gbs,c4412488) ## Key takeaways - Hansa Biopharma submitted an Investigational New Drug application to the US FDA for HNSA-5487 in Guillain-Barré syndrome. - Subject to FDA review, Hansa plans a small Phase 2a single ascending dose study in GBS patients followed by a pivotal study. - In a Phase 1 study, 36 healthy volunteers received single ascending doses of HNSA-5487, which reduced IgG by more than 95% within a few hours. [Hansa Biopharma](https://akta.pro/company-profiles/0000ec1/hansa-biopharma) AB has submitted an Investigational New Drug application to the US Food and Drug Administration for HNSA-5487, its novel IgG-cleaving enzyme, to support clinical development in Guillain-Barré syndrome. The Lund, Sweden-based company announced the submission on October 20, 2026, according to [news.cision.com](https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-submission-of-ind-application-to-us-fda-for-hnsa-5487-in-gbs,c4412488). ## Hansa's IND Submission and Planned GBS Studies Hansa Biopharma is a commercial-stage biopharmaceutical company developing immunomodulatory therapies based on IgG-cleaving enzyme technology, with operations in Europe and the U.S. and a listing on Nasdaq Stockholm under the ticker HNSA. The company said the IND submission advances HNSA-5487 toward clinical evaluation in patients with GBS. Renée Aguiar-Lucander, CEO of Hansa Biopharma, said: "The IND submission for HNSA-5487 represents an important milestone in the development of HNSA-5487 and our pursuit of treating rare diseases. We look forward to initiating the clinical development program and generating the patient data FDA has requested to enable us to move into a pivotal study." Subject to FDA review of the IND, Hansa plans to initiate a small Phase 2a single ascending dose study of HNSA-5487 in patients with GBS, followed by a pivotal study. The program is supported by a prior clinical study with imlifidase in GBS, which provided clinical evidence for the therapeutic potential of targeting pathogenic IgG in the disease. In a double-blind, randomized, placebo-controlled Phase 1 study, 36 healthy volunteers received single ascending doses of HNSA-5487 by intravenous infusion. The study assessed safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity, and HNSA-5487 demonstrated a rapid and robust reduction of IgG of more than 95% within a few hours. ## Hansa's Funding and Idefirix Licensing Record According to akta.pro [company records](https://akta.pro/company-data), Hansa closed a $30 million unsecured convertible senior note financing with Athyrium Capital Management in March 2026, extending its cash runway into mid-2027. In May 2026, the company out-licensed exclusive development and commercialization rights for Idefirix in the EU, UK, Switzerland, Norway, Iceland, Liechtenstein and MENA to SERB Pharmaceuticals for €115 million, comprising €110 million upfront and a €5 million milestone. The same records show total funding of $205.2 million. ## Earlier Hansa Biopharma Developments In October 2026, Hansa Biopharma said CEO Renée Aguiar-Lucander, COO Maria Törnsén and CFO Adam Cutler would attend a fireside chat at the Virtual U.S. Bancorp / BTIG Kidney Health Forum on October 14, 2026, according to news.cision.com. In September 2026, the company expanded its board to eight directors at an extraordinary general meeting, electing Shannon Campbell and Gregory Perry, The future of trading reported. In August 2026, Hansa confidentially submitted a draft registration statement to the SEC for a potential listing of American Depositary Shares on the Nasdaq Global Market, Affarsvarlden reported. ## Hansa's Next Steps With the FDA The FDA accepted the BLA for imlifidase in desensitization of highly sensitized adult kidney transplant patients and assigned a PDUFA action date of December 19, 2026, according to akta.pro company records. Hansa's planned Phase 2a study of HNSA-5487 in GBS follows FDA review of the IND. ## Companies in this story - [Hansa Biopharma company profile](https://akta.pro/company-profiles/0000ec1/hansa-biopharma) · website: https://hansabiopharma.com --- News for Agent · https://newsforagent.com/llms.txt