Unlearn

Unlearn is a pioneering AI company dedicated to revolutionizing medicine by eliminating trial and error. The company has developed a groundbreaking platform that creates Digital Twins of patients for clinical trials. These Digital Twins are comprehensive, longitudinal forecasts of what would happen to a specific patient if they were in a control group. By leveraging these AI-generated prognostic models, Unlearn enables pharmaceutical companies and biotechs to run smaller, faster, and more successful clinical trials. Their mission is to advance AI to transform medicine into a computational science, making precision medicine the new standard of care for everyone.

The technology is built on disease-specific machine learning models trained on an extensive and proprietary database of over 1 million longitudinal clinical study records. This vast dataset spans more than 20 indications, including complex areas like neuroscience (Alzheimer's, Parkinson's, ALS), immunology, and metabolic diseases. This rich data foundation allows Unlearn to generate highly precise and reliable forecasts for each trial participant using only their baseline data.

How to use Unlearn

Engaging with Unlearn is a collaborative process designed for biopharma partners who need speed, security, and adaptability. The typical workflow is as follows:

1. Partnership and Consultation: A pharmaceutical or biotech company partners with Unlearn to support a specific clinical study. Unlearn's team works with the sponsor to understand the trial's objectives, endpoints, and design.
2. Data Integration: For each participant enrolled in the trial, only their baseline data is required. Unlearn's platform ingests this baseline information to generate a corresponding Digital Twin.
3. Digital Twin Generation: Using its disease-specific machine learning models, the Unlearn Platform generates a personalized forecast for each participant. This forecast predicts the participant's clinical outcomes at every future time point as if they were receiving a placebo.
4. Statistical Analysis: The Digital Twin's predicted outcome is used as a prognostic covariate in the final statistical analysis of the trial. This significantly reduces the variance of the treatment effect estimate.
5. Trial Optimization and Decision-Making: The results enable sponsors to achieve higher statistical power with fewer participants, accelerate enrollment timelines, and make more confident go/no-go decisions. The platform can also be used to explore predicted outcomes for any subgroup, supporting interim analyses and trial design optimization.

Unlearn offers flexible engagement models, including a full-service model where they handle the process end-to-end, and a custom infrastructure model where they integrate with a client's proprietary data and systems.

Core Features of Unlearn

• Digital Twin Generators: The core technology that creates a prognostic forecast for each trial participant based on their baseline data.
• Trial Timeline Acceleration: Enables the design of smaller randomized controlled trials (RCTs) that maintain or boost statistical power, leading to faster enrollment and completion.
• Enhanced Decision-Making: Provides predicted outcomes for any subgroup at any time point, supporting critical decisions like interim analyses and go/no-go milestones.
• Trial Design Optimization: Allows sponsors to use digital twins to refine inclusion/exclusion criteria and clinical endpoints, designing more efficient trials with a higher probability of success.
• Regulatory Acceptance: Unlearn's methods are qualified by the European Medicines Agency (EMA) for use in Phase 2 and 3 trials and align with current FDA guidance on using prognostic covariates.
• Broad Therapeutic Area Coverage: Models and expertise cover over 20 indications, with deep specialization in neuroscience, immunology, and metabolic diseases.

Use Cases for Unlearn

Unlearn's technology is being applied by leading global pharmaceutical companies and innovative biotechs to solve critical challenges in clinical development.

• Reducing Sample Size: AbbVie utilized Unlearn's Digital Twins in an Alzheimer's disease trial, demonstrating a significant reduction in treatment effect variance, which could have translated to smaller sample sizes, faster enrollment, and cost savings.
• Strengthening Early Efficacy Signals: In an early-stage Alzheimer's study, remynd partnered with Unlearn to use digital twins to predict disease progression, helping to strengthen confidence in early clinical signals of efficacy.
• External Comparator in Single-Arm Studies: ProJenX used AI-generated digital twins as a built-in placebo control for each participant in an open-label ALS trial, providing greater confidence in efficacy findings compared to traditional external controls.
• Optimizing Trial Design: Trace Neuroscience collaborated with Unlearn to mine their extensive ALS database, enabling smarter trial designs and more informed decisions for planning their Phase 1/2 trial.

Advantages of Unlearn

Partnering with Unlearn provides a distinct competitive edge in drug development. Key advantages include:

• Increased Efficiency: Run smaller, faster trials without sacrificing statistical power.
• Reduced Risk: Make more informed decisions earlier in the development process, reducing the risk of late-stage failures.
• Cost Savings: Lower patient recruitment and trial operational costs by reducing the required sample size.
• Scientific and Regulatory Rigor: The platform is grounded in cutting-edge machine learning research and is recognized by major regulatory bodies like the EMA and FDA.
• Deep Expertise: Unlearn's team consists of experts in machine learning, clinical research, and data science, providing robust support and insights.

Pricing and Plans

Unlearn operates on an enterprise B2B model, providing custom solutions tailored to the specific needs of pharmaceutical and biotech companies. Pricing is not publicly available and is determined based on the scope of the project, the therapeutic area, and the engagement model chosen. To receive a custom quote and a detailed demonstration of the platform, interested parties are encouraged to contact Unlearn directly to book a demo.