Spinogenix's SPG302 ALS Drug Shows Positive Phase IIa Results, Advances to Registrational Trial Amid Lingering Questions

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Spinogenix's SPG302 met its primary endpoint of safety and tolerability in a Phase IIa study (NCT05882695) with no serious adverse events over six months of daily dosing1.

82% of patients showed stable or improved ALS Functional Rating Scale (ALSFRS-R) scores, with a 76% slower decline rate compared to historical PRO-ACT database controls1.

EEG recordings indicated improvements in ALS-associated brain patterns, and biomarkers supported effects on ALS-impacted brain areas1.

The company plans a registrational-directed trial following the positive November 4 data, amid challenges in ALS drug development1.

Recent long-term data on approved drug tofersen (Qalsody) for SOD1-ALS showed ~25% of patients with improvements in strength and function over 3-5 years, but this is a separate therapy23.

Sources:

1. https://www.clinicaltrialsarena.com/news/spinogenix-als-spg003-phase-iia-success/

2. https://medicine.washu.edu/news/new-als-drug-stabilizes-decline-with-trend-toward-improved-strength-mobility-for-some/

3. https://www.psychiatrist.com/news/first-targeted-als-drug-shows-it-can-change-the-disease/