The ALS Association

ALS Ice Bucket Challenge Progress

UPDATE: Origent Data Sciences Moves Forward with Cytokinetics’ Phase III Trial Data

May 2, 2017

In March 2016, The ALS Association awarded Origent Data Sciences a grant to enable a research partnership with Cytokinetics Inc. with the objective to improve clinical trial design in people with ALS by harnessing the power of predictive computer algorithms. Dr. David Ennist, Chief Scientific Officer of Origent, and his team designed the models to predict the course of ALS disease progression using publicly available clinical trial data. The ultimate goal for the models is to enable faster, less expensive ALS clinical trials that may require fewer people, resulting in a more rapid path to new therapeutics.

In the past year, Origent, under Dr. Ennist’s leadership, made progress in this collaboration and presented the first part of the research project at the 27th International Symposium on ALS/MND in Dublin. Using results from BENEFIT-ALS, Cytokinetics’ phase IIb clinical trial of tirasemtiv, a fast skeletal troponin activator (FSTA), Origent reported that their computer algorithms could successfully predict slow vital capacity (SVC) at times subsequent to baseline and that forced vital capacity (FVC) records could predict SVC score of people living with ALS. Both observations are a promising step forward.

With these data in hand, Origent is now ready to begin to prospectively validate their computer model to predict the course of ALS disease progression. This time around, they are using screening and baseline data from VITALITY-ALS, Cytokinetics’ ongoing phase III clinical trial of tirasemtiv, to predict outcomes in these patients, prior to unblinding the data. After unblinding, Origent’s prospective predictions will be compared with actual outcomes in these patients. This is the first time a dataset from an ongoing clinical trial in patients with ALS will be used for prospective analyses before actual results are available.

The ALS Association is pleased with this fruitful collaboration and its progress. We look forward to hearing more from Origent about their predictions of outcomes in VITALITY-ALS later this year.

Learn more:
Read original ALS Association press release.
Read joint Cytokinetics Origent press release.

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