This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS. The study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.
Key Inclusion Criteria:
- Diagnosis of ALS according to the World Federation of Neurology revised EI Escorial
criteria.
- Onset of weakness within 3 years prior to Day 1 visit.
- Slow Vital Capacity ≥ 50% of predicted normal adjusted for sex, age, and height
(from the sitting position).
- ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at the Screening visit (Week
-2).
- If female, must be postmenopausal, surgically sterilized, or childbearing potential
must agree to use highly effective methods of contraception from Screening until 3
months after the last infusion with study medication.
- Males with a woman partner of childbearing potential must agree to use highly
effective methods of contraception from Screening until Week until 3 months after
the last infusion with study medication.
- Documented history of vaccinations within 5 years prior to Screening visit against
encapsulated bacterial pathogens or willing to undergo vaccinations.
Key Exclusion Criteria:
- Clinically significant intercurrent illness, medical condition, or medical history
that would jeopardize the safety of the participant, limit participation, or
compromise the interpretation of the data derived from the participant.
- Participants with body weight > 150 kilograms.
- Antinuclear antibodies (ANA) titer ≥ 1:160 (for either of the 2 ANA results a
minimum of 2 weeks apart) during the Screening Period.