Clinical-stage biotechnology company ProJenX has announced a collaboration with Unlearn to implement generative AI technology for a Phase I PRO-101 trial of prosetin, a potential amyotrophic lateral sclerosis (ALS) treatment.
Prosetin is a brain-penetrant, MAP4 kinase (MAP4K) inhibitor.
Go deeper with GlobalData
The partnership aims to enhance the trial’s evaluation process by employing the ALS-Digital Twin Generator (ALS-DTG) of Unlearn to create digital twins for trial participants with ALS.
Digital twins will serve as virtual placebos for patients receiving prosetin.
This approach is expected to assist in assessing clinical outcomes such as ALSFRS-R, Slow Vital Capacity, and plasma neurofilament light during a 52-week open-label extension.
The ALS-DTG is a machine-learning generative model that has been trained on patient-level data. It is capable of producing probabilistic forecasts of individual health outcomes, which are used to predict longitudinal clinical placebo outcomes, biomarkers, and lab results, irrespective of the trial participant’s randomisation assignment.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataWith four parts, the hybrid Phase I trial will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of prosetin in both healthy subjects and ALS patients.
Parts 1a and 1b enrolling healthy volunteers have been completed.
The prospective Parts 1c and 1d portions of the trial will evaluate prosetin in ALS patients.
ProJenX president and CEO Stan Abel said: “ProJenX and Unlearn’s collaboration aims to extract valuable insights that will help us expedite clinical trials and more efficiently evaluate prosetin in individuals living with ALS.
“Digital twins provide the opportunity for us to compare participants with ALS who are dosed with prosetin to their digitally generated placebo versions of themselves based on their baseline measurements. In PRO-101, this collaboration will enhance our interpretation of the effects of prosetin on ALS patients to support a more efficient and data-driven clinical development programme.”
In November last year, ProJenX received authorisation from Health Canada to commence the final part of the Phase I trial of prosetin in ALS patients.
