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Augie’s Quest Reports First Subject Successfully Enrolled in AT-1501 Phase 1 Study, a First-of-its-Kind, Promising Treatment for ALS

Posted: November 28, 2018 in Other News

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Augie's QuestAugie’s Quest

ORANGE COUNTY, CA – The ALS Therapy Development Institute (ALS TDI), the world’s foremost nonprofit biotech focused solely on ALS (amyotrophic lateral sclerosis), in partnership with Anelixis Therapeutics, LLC., and via targeted funding from Augie’s Quest to Cure ALS, announced the first human was successfully given a dose of AT-1501, a promising investigative drug to treat the neurodegenerative disease.

Not only does this critical step signal the continuation of the phase 1 human safety trial and the first achieved milestone for AT-1501, it is the first time a nonprofit drug discovery center has successfully brought a new molecular entity, this type of experimental treatment for ALS, from inception through to the clinical trial phase.

“Our disruptive nonprofit, and its laser-focused ALS research model, is paying off. Today I have new hope we will uncover effective treatments and an ultimate cure for ALS – and quite possibly, in my lifetime,” says Augie Nieto, Chairman of both ALS TDI and Augie’s Quest. The business leader and fitness industry icon, who has lived with ALS for more than a decade, is instrumental in advancing the two organizations’ collective vision: to fast-track the cutting-edge science needed to fight ALS by urgently funding more and better drug developments, like AT-1501, and move them into clinical trials to benefit people with ALS.

“ALS isn’t incurable, it is underfunded. So that’s where we’ve devoted our energy this last decade, inspiring tens of thousands globally, particularly our friends in the fitness industry, to join our quest and #EndALS. Collectively, Augie’s Quest and ALS TDI have raised more than $150 million for our shared cause. These continued gifts from our committed community are making this clinical trial – and someday an ALS cure – a reality,” Nieto adds.

Following the acceptance of the Investigation New Drug (IND) application with the Food & Drug Administration (FDA), this phase 1 safety trial is now enrolling both healthy volunteers and a total of eight people with ALS to determine the overall safety and tolerability of AT-1501. This experimental antibody is designed to bind to and block a protein target called CD40 ligand (CD40L), shown to be overactive in ALS patients. The trial will also be monitoring the drug’s pharmacokinetics, or in other words, how long the AT-1501 drug circulates within the body.

“This is an important victory for the ALS community,” said Steve Perrin, PhD., Chief Executive Officer, ALS TDI. “Because of the complex nature of the disease, it is extremely challenging to take ALS lab discoveries and translate our research into well-designed clinical drug trials. But that is what we’re dedicated to doing. Seeing our lead candidate, AT-1501, move forward is a great sign our approach to ALS drug development is working and a strong indication we will be able to advance other promising discoveries from ALS TDI’s deep pipeline, as well.”

Augie’s Quest, together with its many generous donors and corporate cause marketing partners, have raised more than $5 million over the past five years and is a leading source of support in the development of AT-1501. Fitness industry efforts to raise urgent funds and awareness on behalf of Augie’s Quest, including Orangetheory Fitness’ system-wide annual #IBurn4ALS challenge, Zumba and Strong by Zumba’s upcoming January 2019 global campaign, ClubCorp’s Charity Classic events, Shea Homes’ commitment, countless IHRSA member activities (a global community of health and fitness professionals), and many more, are helping to fast-track this critical ALS research.

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