Case Studies

The company is conducting a Phase 2 Clinical Trial of their novel HB-1 compound aimed at treatment of PTSD. The company is looking to address a challenge that has become increasingly common in the neuropsychiatric drug development space: proving clinical efficacy in the face of biological heterogeneity.

In recent years, numerous psychiatric drugs have failed in clinical trials—not necessarily because the compounds lack therapeutic potential, but because they are evaluated across broad, heterogeneous patient populations. This “one-size-fits-all” approach overlooks crucial biological and phenotypic differences that influence how individual patients respond to a given treatment. As a result, many promising therapies appear ineffective at the population level, even though they may be highly effective for specific subgroups.

To overcome these challenges, Honeybrains Biotech selected Brainify.AI to provide a comprehensive ‘white glove’ biomarker discovery service. As part of this engagement, Brainify.AI will collect EEG data and apply its EEG Foundational Model to identify the drug’s responder sub-population, thereby improving HB-1’s observed clinical effectiveness.

Brainify.AI was engaged to address this challenge with a tailored biomarker solution leveraging EEG Foundational Model. Brainify.AI has come up with a strategy to enable biomarker discovery and implementation:

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

This approach powered by the EEG Foundational Model offers several key advantages for Honeybrains Biotech:

1. 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.

2. Adaptability: The EEG Foundational Model serves as a versatile basis from which specific biomarkers for various psychiatric conditions and treatments can be derived. This flexibility accelerates the development and validation of treatment-specific biomarkers, significantly reducing time and costs.

3. Enhanced Prediction Accuracy: Such a model allows for precise prediction of treatment and placebo responses, greatly increasing the likelihood of clinical trial success and the efficiency of biomarker discovery and validation processes.

Electroencephalography (EEG) is considered an excellent choice for biomarker research for several reasons:

1. Objective Biomarkers: EEG provides objective neurophysiological biomarkers that can measure brain activity directly, offering insights into the neurological effects of treatments and placebo responses.

2. Non-invasive and Scalable: EEG procedures are non-invasive, relatively low-cost, and practical for widespread implementation across clinical trial sites, thus being scalable and accessible for diverse patient populations. 

The expected outcomes of adopting Brainify.AI’s EEG biomarker approach for Honeybrains Biotech include:

• Enhanced Clinical Trial Success: By incorporating EEG-based biomarkers, particularly for placebo response prediction, Honeybrains Biotech can significantly improve trial outcomes, 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, substantially expanding market reach and revenue potential.
• Cost Efficiency: Adopting Brainify.AI’s platform would substantially reduce overall clinical trial costs by minimizing required sample sizes and enhancing statistical power without compromising trial quality.
• Regulatory Advantage: The EEG biomarkers (once validated) facilitate regulatory approval processes by clearly demonstrating treatment efficacy, thus streamlining FDA interactions and approvals for HB-1 and associated companion diagnostics.

Overall, adopting Brainify.AI’s full-stack neurotech platform (integrated hardware, software, AI and CDx) presents a strategic advantage for Honeybrains Biotech by addressing critical clinical and commercial challenges in psychiatric drug development.