Darwin Biotechnology Enrolls First Patient in Phase II Trial of MSC-Derived Protein Complex for Persistent Neurological Deficits After Ischemic Stroke

Key Points

• Darwin Biotechnology enrolled the first patient on October 27, 2026, in its Phase II trial of Darwin-ALT001 for persistent neurological deficits following ischemic stroke.
• On November 4, Darwin reported that the first patient was in stable condition with favorable safety observations.
• Darwin-ALT001 is an investigational, cell-free, non-exosomal protein complex derived from mesenchymal stem cells.

Darwin Biotechnology (Hubei) Co., Ltd. announced that the first patient was enrolled on October 27, 2026, in its Phase II trial evaluating Darwin-ALT001 for patients with persistent neurological deficits following ischemic stroke. On November 4, 2026, Darwin reported that the patient was in stable condition with favorable safety observations and that trial activities were progressing as planned.

Many ischemic stroke survivors experience lasting neurological impairments, including motor deficits, that severely affect daily functioning and quality of life. This population still has substantial unmet medical needs.

Darwin-ALT001 is an investigational, cell-free, non-exosomal, allogeneic (donor derived) mesenchymal stem cell (MSC)-derived protein complex developed through Darwin’s ECIWEP® platform. The platform uses stress induction to stimulate targeted protein complex secretion from MSCs.

The Phase II trial will further evaluate the efficacy and safety of Darwin-ALT001 and explore its potential to improve neurological function in this patient population.

Darwin said it will work closely with participating clinical study sites to advance the trial in accordance with Good Clinical Practice, with patient safety as its foremost priority.

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