Spinogenix’s ALS Drug Advances Toward Registrational Trial
Spinogenix is moving its lead candidate, SPG302, closer to a registrational trial after promising results in a mid-stage study for amyotrophic lateral sclerosis (ALS).
Phase IIa Trial Results
In the Phase IIa study (NCT05882695), SPG302 demonstrated a strong safety profile, meeting its primary endpoint of safety and tolerability with no treatment-emergent serious adverse events during six months of daily dosing in ALS patients.
Effectiveness in Slowing ALS Decline
The drug showed encouraging efficacy by stabilizing or improving the rate of ALS-associated decline in 82% of patients, measured by the revised ALS Functional Rating Scale (ALSFRS-R) at the end of treatment.
Compared to historical controls from the PRO-ACT database—the largest publicly integrated ALS clinical trial dataset—patients on SPG302 experienced a 76% slower decline over six months.
Supporting Neurological Evidence
Electroencephalogram (EEG) recordings taken during the trial revealed “improvements in ALS-associated patterns,” reinforcing the drug’s potential to delay functional loss in ALS.
“Improvements in ALS-associated patterns,” which Spinogenix says supports the drug’s observed capacity to stave off functional decline.
About Spinogenix and SPG302
- SPG302 is a potentially disease-modifying drug for ALS.
- Spinogenix plans to initiate a registrational trial based on positive Phase IIa data.
- The trial’s goal is to address significant unmet needs in the ALS treatment market.
Spinogenix’s SPG302 offers promising advances in slowing ALS progression while maintaining safety during extended daily use, justifying further late-stage clinical evaluation.