Sarepta-partnered Hansa touts new phase 2 data of one-trick pony immunological treatment
28 Nov 2022
Phase 2Gene TherapyClinical ResultPhase 3Immunotherapy
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Source: FierceBiotech
Hansa Biopharma plans to initiate a clinical trial in 2023 testing its lead asset as a pre-treatment prior to Sarepta's Duchenne gene therapy.
Hansa Biopharma is hailing new phase 2 data of its all-in-one transplantation treatment imlifidase as evidence of the med’s superiority to standard of care for patients with antibody-mediated rejection.
The new results, released Monday by Hansa, found that imlifidase did a better job than plasma exchange at reducing donor-specific antibodies (DSAs) five days after treatment following a kidney transplant. The company says the treatment reduced the majority of DSAs in the patient population whereas plasma exchange required “multiple sessions” for antibody levels to adequately drop. The company says no safety singals were identified, and more robust data will be published in 2023.
“What we are seeing from the first readout of our AMR phase 2 trial is very encouraging and provides further evidence of the potential imlifidase may have for management of transplant rejection,” said Christian Kjellman, Hansa’s chief scientific officer, in a release. Stanley Jordan, M.D., director of the pediatric and adult nephrology division at Cedars Sinai in Los Angeles and principal investigator of the trial, added in the release that the results were promising and could lead to new therapies for post-transplant AMR.
The global, open-label randomized trial included 30 patients across five countries in three continents, two-thirds of which received imlifidase. The estimated study completion date is March 2023.
The results are an obvious boost for the company, specifically since so much of its clinical ambitions hinge on the success of imlifidase. The med is approved in Europe as a desensitization treatment for kidney transplant patients and is also being tested in six other indications. Two of those indications are as a pre-treatment prior to Sarepta’s treatments for Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy, respectively, with Hansa expecting to initiate a trial for DMD in 2023. Hansa is also partnered with AskBio to test imlifidase as a pre-treatment to the latter’s Pompe disease gene therapy.
But beyond imlifidase, Hansa’s roster is sparse. The only other two drugs in Hansa’s pipeline are in the preclinical stage, with potential indications spanning cancer immunotherapy, transplanation and autoimmune disease.
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