Inclusion Criteria:
- ALS diagnosis - Age 18 -80 years at time of signing informed consent form - Ineligible for other interventional ALS clinical research participation - Vital Capacity less than 50% of predicted capacity for age, height, and sex - If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking SPG302.
- Life expectancy of at least 6 months, according to Investigator's judgement Exclusion Criteria:
- Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient - Known ongoing or clinically uncontrolled cardiac disease - Clinically significant liver disease - Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement - Concomitant use of another investigational medical product for treatment of ALS - Unable to reliably and regularly swallow whole oral medications on a daily basis

This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to SPG302 to adult patients with ALS who have progressed following available standard of care.

• Spinogenix

NCT07088159 (First Published: 7/18/2025)