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EEG Biomarker Discovery forPhase 2 PTSD Clinical Trial

How Honeybrains Biotech partnered with Brainify.AI to identify treatment responders and improve clinical trial outcomes using our EEG Foundational Model.

The Challenge

Honeybrains Biotech is a U.S.-based life science company focused on treating anxiety-related disorders such as Panic Disorder and PTSD. The company is conducting a Phase 2 Clinical Trial of their novel HB-1 compound aimed at treatment of PTSD.

The challenge: proving clinical efficacy in the face of biological heterogeneity. In recent years, numerous psychiatric drugs have failed in clinical trials—not because the compounds lack therapeutic potential, but because they are evaluated across broad, heterogeneous patient populations.

Many promising therapies appear ineffective at the population level, even though they may be highly effective for specific subgroups.

Our Strategy

Brainify.AI was engaged to address this challenge with a tailored biomarker solution leveraging our EEG Foundational Model.

1

EEG Protocol Development

Design protocols including scales, ERP (event-related potential) tasks, and standardized procedures for biomarker discovery

2

EEG Protocol Implementation

Install, verify, and test EEG/ERP hardware and software to ensure readiness for data collection

3

EEG Data Collection

Conduct day-to-day EEG acquisition at clinical sites by trained Brainify.AI technicians

4

Biomarker/CDx Research

Leverage Brainify.AI's EEG Foundational Model, trained on 150,000+ subjects, for biomarker discovery and validation

5

Post-Approval CDx Deployment

Implement the biomarker on Brainify.AI's neurotech platform for clinical practice use

Why EEG Foundational Model

Large-scale Training Data

Brainify.AI's EEG Foundational Model is trained on an extensive dataset (over 150,000 subjects), enabling it to recognize complex, generalized patterns associated with neuropsychiatric disorders.

Adaptability

The EEG Foundational Model serves as a versatile basis from which specific biomarkers for various psychiatric conditions and treatments can be derived, significantly reducing time and costs.

Enhanced Prediction Accuracy

The model allows for precise prediction of treatment and placebo responses, greatly increasing the likelihood of clinical trial success.

Why EEG?

Objective Biomarkers

EEG provides objective neurophysiological biomarkers that measure brain activity directly.

Non-invasive & Scalable

EEG procedures are non-invasive, relatively low-cost, and practical for widespread implementation.

Expected Outcomes

Enhanced Clinical Trial Success

By incorporating EEG-based biomarkers, particularly for placebo response prediction, ensuring clearer differentiation of HB-1's efficacy versus placebo.

Increased Market Penetration

With validated EEG biomarkers serving as companion diagnostics (CDx), HB-1 could potentially be elevated from fourth- or fifth-line treatments to second- or third-line options.

Cost Efficiency

Substantially reduce overall clinical trial costs by minimizing required sample sizes and enhancing statistical power without compromising trial quality.

Regulatory Advantage

Objective neurophysiological measures can support an efficacy narrative alongside clinical scales. Regulatory acceptance depends on the sponsor’s data and FDA’s review.

Full-Stack Neurotech Platform

Adopting Brainify.AI's full-stack neurotech platform (integrated hardware, software, AI and CDx) presents a strategic advantage by addressing critical clinical and commercial challenges in psychiatric drug development.