By Karen Roman
Darwin Biotech said it presented data from its placebo-controlled Phase 1 study of ALT001 to treat amyotrophic lateral sclerosis at the 2026 Network of Excellence for ALS (NEALS) Annual Meeting.
ALT001 is a cell-free protein complex derived from human mesenchymal stem cells, with test results highlighting that treatment was well tolerated with no serious adverse events, the company stated.
Darwin Biotech mentioned it expects to move further evaluating ALT001 in a U.S. Phase 1/2a study with higher doses over a longer period.
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“These results give us a clear path forward for ALT001 globally,” said Wang Yu, Darwin’s founder and CEO. “Our team at the NEALS Annual Meeting has been holding conversations with some of the most prominent U.S. members of the ALS medical community and we look forward to advancing our clinical program in the United States as well.”
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