March Progress Report and COVID-19 Impact

As you all are, we too are closely monitoring the impact of COVID-19 on the HEALEY ALS Platform Trial timelines and operations. The bottom line is this: we are committed to beginning the trial as soon and as safely as we can. What exactly that will look like is very much in flux these days as we adapt to the ever changing COVID-19 reality. We will be hosting a webinar on Wednesday, April 8 at 3:00 pm to cover these and other issues related to the trial.

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This groundbreaking approach cuts the time to find an effective treatment in half, decreases costs by a third or more, and is supported by our patients, the FDA, ALS clinicians and scientists and our pharma colleagues.

 Saves TimeSaves Money Merit Cudkowicz, MD, MSc
Director, Sean M. Healey & AMG Center for ALS

 

On March 20, 2019, we issued the first call for proposals for the initial drugs for the HEALEY ALS Platform Trial and we received an outstanding response with almost 30 applicants from 10 countries. We received initial "May Proceed" approval from the US Food & Drug Administration (FDA) in late January, 2020, and expect to begin recruiting and enrolling patients soon.

Read about our FDA approval

Merit Cudkowicz, MD, MSc, Director of the Healey Center for ALS, discusses the impact of the “May Proceed” notice from the FDA for three drugs in first ALS platform trial

We fully anticipate that more treatments will be added to the HEALEY ALS Platform Trial, supported by pharma, foundation partners, philanthropy, federal and other fundraising initiatives. We encourage the academic and industry community to engage with the Healey Center ALS Trial Design Team at any time to work together on ALS therapy development. Nominations of therapies for inclusion in the platform trial will continue on an ongoing, rolling basis.

Platform Trial Presentation

Platform Trial Presentation

View slides from the 30th International Symposium on ALS/MND in Perth, Australia.

Thanks to Our Supporters

Thanks to Our Supporters

The HEALEY ALS Platform Trial is supported by many foundations and generous donors.