Unlearn.AI and Merck KGaA have signed a multi-year partnership to expedite late-stage immunology clinical trials using new designs that comprise Digital Twins.

In the initial stage, the alliance will work on progressing the regulatory approval of candidates in the immunology pipeline of Merck.

The partnership will potentially be extended into various other treatment areas.

In collaboration with various pharma, biotech firms and academic researchers, Unlearn streamlines human clinical trials by integrating artificial intelligence (AI) methods into historical patient data.

It produces Digital Twins, which are complete, longitudinal forecasts of the prognosis of patients on a control therapy.

Incorporating Digital Twins into trials is anticipated to lower the enrolment numbers of study subjects without compromising on unbiased estimates of therapy effects.

Twintelligent RCTs merge AI, Digital Twins and new statistical approaches to support smaller clinical trials.

As against current methods such as external control groups, Unlearn’s method for integrating Digital Twins into Twintelligent RCTs does not cause bias and upholds randomisation.

Merck intends to leverage Twintelligent RCTs to integrate prognostic information from Digital Twins into its randomised controlled trials in order to facilitate smaller control arms and create appropriate evidence to back regulatory decisions.

Unlearn founder and CEO Charles Fisher said: “We are very pleased to establish this collaboration with Merck KGaA, Darmstadt, Germany and to be working with its world-class team who shares our vision for how AI and other innovative technologies can expand access to new medicines.

“Our solution has successfully proven that it can reduce the size of control arms by 30% or more and generate reliable clinical evidence in a fraction of the time.”

In April 2020, Unlearn.AI raised $12m in a Series A financing round to expedite the use of its ML technology to boost effectiveness of trials.