Quotient Sciences Reports AI Clinical Trial Milestone

Editor’s Take: Quotient went all in on AI last year when it announced a multi-year strategic partnership with Intrepid Labs to advance the use of artificial intelligence in early drug development.

Quotient Sciences, a global integrated CRDMO, reported interim results from a clinical study in which a proprietary AI algorithm selected modified-release formulation compositions and doses during the trial. The algorithm reached the preset pharmacokinetic target within three dosing periods, meeting the program’s interim objectives.

“Predicting how a modified-release tablet will behave in humans is difficult,” said Andrew Lewis, Ph.D., Chief Scientific Officer at Quotient Sciences. “The interim data show that the algorithm learned that relationship quickly and accurately.”

The clinical work follows laboratory screening in which the same algorithm learned the relationship between tablet composition and in vitro drug release while screening one-third fewer formulations than conventional methods. The current trial tests whether that capability can translate to pharmacokinetic performance in humans.

How the Trial Worked

The algorithm entered the trial trained only on in vitro release data. After each dosing period, it was retrained on dissolution and pharmacokinetic data from healthy participants, then used to select the next composition and dose. Quotient Sciences set the operating limits, including a first-prototype dose cap, and a safety committee approved each composition before manufacture and dosing.

The study used a generic drug selected for its established safety record and published data. It was included to test the algorithm, not as a development candidate, and Quotient Sciences does not plan to progress it as a product.

“We set out to answer three questions,” Lewis said. “Can the model learn the relationship between formulation composition and performance in humans, and if so, how quickly and how accurately? On the interim evidence, it can, and quickly enough that we expect to need less clinical testing to develop modified-release formulations for other molecules.”

Dosing continues, and Quotient Sciences expects to report full data when the study is complete toward the end of this year.