Seelos Therapeutics Inc. (NASDAQ:SEEL) has announced that its Phase IIb/III SLS-005 (trehalose) study has been selected by Sean M. Healey & AMG Centre for ALS at Massachusetts General Hospital to be part of the HEALEY ALS platform Study. This is the first-ever study platform for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) treatment.
SLS-005 included in HEALEY ALS Platform Trial
Raj Mehra, the company’s CEO, stated that the inclusion of Seelos’s registrational phase IIb/III SLS-005 study in the first-ever platform trial is a huge milestone. It is a result of considerable work done in the identification of trehalose as a possible treatment to evaluate in ALS. He added that the recognition from the Healey’s Centres of the therapy is a huge validation for the company and being part of the platform trial will help accelerate the trial by offering enhanced access to patients.
Principal HEALEY ALS Platform Trial Investigator, Merit Cudkowicz said that they are delighted to work with Seelos. Merit said that they are looking forward to working with Seelos to study SLS-005 in expedited format via the HEALEY ALS platform. The trial design team is expected to work closely with the company on their regimen specific protocol and completion of necessary steps with the FDA’s and central ethics review board.
HEALEY ALS Platform Trial enabling the simultaneous study of ALS therapies
It is important to note that the HEALEY ALS Platform Trial has been designed to evaluate potential ALS treatments simultaneously thus accelerating potential treatment timing from identification through testing. Most importantly the platform trial model which has been successful in oncology aims to expedite multiple therapies studies this giving investigators a chance to test more possible therapies, reduce costs, shorten development timelines and increase patient access.
The FDA recently granted SLS-005 Orphan Drug Designation for ALS treatment. SLS-005 is a molecular disaccharide that can cross the blood-brain barrier to stabilize and activate autophagy, the process which releases materials from cells. It activates autophagy through Transcription Factor EB activation which is a vital factor in autophagy gene expression.