BrainStorm Cell Therapeutics Inc (BCLI)

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Brainstorm Cell Therapeutics: Upcoming BLA In ALS

Aug. 21, 2022 3:57 AM ETBrainstorm Cell Therapeutics Inc. (BCLI)

Summary

Brainstorm Cell Therapeutics is a company developing NurOwn as an autologous stem cell-based treatment for ALS and MS.
NurOwn’s mechanism of action relies on bringing down neuroinflammation and altering glial activity, a recipe that seems to be a winner in neurodegenerative diseases.
After its Phase 3 trial in ALS did not reach its primary endpoint, the company announced on August 15, 2022 that it would still file a BLA in ALS.
Upon reanalysis of the data, statistical significance was in fact found in a predefined subgroup as well as in a larger group of ALS patients.
Like Biogen’s Tofersen but unlike Amylyx’s Albrioza, NurOwn significantly reduces the biomarker Neurofilament Light Chain, which the FDA’s AdCom finds of high value.

On August 15, 2022, Brainstorm Cell Therapeutics (NASDAQ:BCLI) caught the investment community by surprise, announcing that it would file a BLA for ALS. Brainstorm’s NurOwn failed to reach a primary endpoint in its Phase 3 trial in ALS. Yet, corrections to the initial data were reported and an erratum to the initial publication was published. Those corrections, although minor, did mean that statistical significance was shown in a predefined subgroup that had a baseline ALSFRS-R score of ≥35. Additionally, NurOwn also showed benefit in patients with ALSFRS-R scores of at least 26-35. Higher ALSFRS-R score mean less neurodegeneration, meaning NurOwn shows benefit in patients that have not yet reached the final stages of ALS disease.

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