The Sean M. Healey & AMAG Centre for ALS at Mass General has received FDA approval, and The Mass General Brigham Institutional Review Board has authorized Seelos Therapeutics Inc.’s (NASDAQ: SEEL) SLS-005 as an additional treatment in the HEALEY ALS Platform Study.
SLS-005 to be included in HEALEY ALS Platform Trial
The HEALEY ALS Trial Design Committee worked with Seelos to incorporate SLS-005’s phase 2b/3 study in amyotrophic lateral sclerosis on the platform. ALS expert scientists and Healey Centre Science Advisory Committee members will choose experimental treatments entering the platform study.
SLS-005 is a trehalose injection for intravenous infusion, which is a low molecular weight disaccharide that activates autophagy, stabilizes proteins, and crosses the brain barrier. Trehalose has demonstrated in animal models the potential of reducing misfolded proteins aggregation and reduction of pathological material accumulation. In addition, it activates autophagy via Transcriptor Factor EB activation.
Principal investigator Merit Cudkowicz said, “The addition of the fifth regimen continues this new approach of more rapidly testing new therapies for people with ALS. We are grateful to all the foundations and individuals who support the HEALEY ALS Platform Trial, including but not limited to The AMG Charitable Foundation, Tackle ALS, the ALS Association, ALS Finding A Cure, ALS One and The Muscular Dystrophy Association.”
More treatments to be introduced to the Healey ALS platform
Zilucoplan, a small macrocyclic peptide inhibitor of complement component 5 [C5], verdiperstat, an oral myeloperoxidase inhibitor, CNM-Au8, catalytically-active gold nanocrystals to support increased cellular energy production, and pridopidine, a highly selective Sigma1 receptor (S1R) agonist, are the first four investigational treatments. Future treatments are currently being developed and will be introduced to the HEALEY ALS Platform Trial in the near future.
Co-lead investigator in the Trehalose regimen for the trial Shafeeq Ladha said, “We are immensely grateful to all the people living with ALS who have trusted our group and allowed us to continue our long but rewarding path towards finding a treatment for ALS.”