Opyl (ASX: OPL) has unveiled software that harnesses artificial intelligence (AI) to calculate a probability of success for pharmaceutical companies currently developing vaccines, drugs and medical devices in clinical trials.
Importantly, the new AI platform will be able to assist companies in developing drugs and vaccines as part of existing COVID-19 trials.
Opyl claims it is a new generation company operating “at the intersection of artificial intelligence, social media and healthcare”.
The company said its technology provides a means for pharmaceutical companies to improve their chances of success when developing new medical treatments.
Uncertainties and delays around clinical trials remain a challenge and carry a significant risk for drug developers, investors, clinical strategists and medical researchers who value the ability to predict the outcome of an individual clinical trial.
Opyl’s software platform is designed to be deployed by drug and device development companies to refine their clinical trial approaches to improve the outcomes of their clinical studies – with the overarching goal of reducing costs, expediting treatment approval and quantifying the chances of future success – a key consideration for pharma companies when allocating R&D budgets.
Knowing a specific predicted probability score allows developers to tweak trial parameters before they commence, thereby improving upon the trial design and potentially saving “hundreds of millions of dollars”, Opyl said.
Changing the game
According to the company, its software platform can be applied to any therapeutic area or any drug, diagnostic, vaccine or medical device with existing COVID-19 treatments set to be gauged by the new system as a proof of concept.
Opyl said that after completing a major proof-of-concept study, it had found that therapies show a much higher probability of success in clinical studies than vaccines and that it had “identified the two vaccines most likely to succeed their current stage of development compared to all others”.
Opyl attributed the best chance of success to one antibody therapy which it says has the best probability of success of getting a positive phase III outcome over all other programs.
“The early outcome of this software trial, investigating the 475 registered COVID-19 clinical trials related to vaccines or treatments, has delivered results that give us an indication of the power of the predictive platform in identifying the COVID19 trials, or any drug or device trial, with the greatest chance of success,” said Opyl’s chief executive officer Michelle Gallaher.
According to statistics from previous studies, around 13.8% of all drugs in phase I clinical trials eventually win approval from regulators and become marketable.
Typically, vaccines have a higher success rate of 33.4% than most other drugs, while cancer drugs have a far lower rate of success of 3%.
“Our approach is to use AI to not just predict the outcome, but to demonstrate that changing specific clinical trials variables can improve the probability of success. And our goal is to improve the efficiency, improve the application of research funding and ultimately the return on investment for scientists, clinicians, health technology developers and investors,” Ms Gallaher said.
One of the first practical case studies for Opyl’s platform will be the ongoing development of drugs combatting the effects of COVID-19. Currently, there are hundreds of drugs undergoing clinical trials.
Opyl’s AI platform can assist developers by using current and historical global data and considering multiple factors including the numbers of participants in each trial, the dropout rate, trial duration, trial endpoints relative to related studies, and, according to Opyl, can consider the mode of action such as type of protein or vector being employed in a program.
Given the novelty of Opyl’s platform, the next stage of development is to increase the data pool from additional sources, expanding the variables to streamline the existing algorithm and refining specificity and reliability of results.
However, the COVID-19 response could be the tip of the iceberg with Opyl already eyeing wider applications including medical devices.
“Although looking at the current pipeline of COVID-19 programs is an initial application of the AI platform, we are not limiting ourselves to just COVID19 trials,” said Ms Gallaher.
“The AI platform can be applied to all drugs, diagnostics, vaccines and medical devices about to begin or in clinical trials, and our goal is to improve the clinical trial process which will, in turn, save money, time and ensure patients can access treatment options sooner,” she said.