TrivarX Limited Reveals Positive Results from Phase 2 SAMDE Study
TRI (TRI) Share Update July 2024 Monday 29th
TrivarX Announces Positive Phase 2 Results for Depression Screening Algorithm
TrivarX Limited (ASX: TRI) has announced promising results from its Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study, showcasing the potential of its AI-driven algorithm, MEB-001, in effectively screening for major depressive episodes.
Instant Summary:
- Analysis involved 400 patients in Phase 2 SAMDE study.
- MEB-001 is TrivarX’s proprietary AI-driven algorithm for screening cMDE.
- MEB-001 showed high performance with 87% sensitivity and 72% specificity.
- Positive Predictive Value (PPV) of 35% and Negative Predictive Value (NPV) of 97%.
- Results validate MEB-001’s effectiveness in screening and diagnosing cMDE.
- No current screening for cMDE in sleep centers globally, representing a major commercial opportunity.
- TrivarX aims to make MEB-001 the first depression screening tool used in clinical practice in sleep centers.
Study Overview
TrivarX Limited has successfully completed its Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study, utilizing its proprietary AI-backed algorithm, MEB-001. The study aimed to use MEB-001 to detect the likelihood of a current Major Depressive Episode (cMDE) using Clinician Reporting Outcomes (CRO) assessment in individuals referred to sleep clinics. A total of 400 patients were recruited across 15 sleep centers in the US.
Out of the 400 patients, 73 were excluded due to incomplete data or a split night/titration sleep study. Additionally, MEB-001 automatically identified 32 patients with significant anomalies in their sleep data. The algorithm was locked prior to the analysis, ensuring no data from Phase 2 was used in its training.
Performance Results
The analysis of the results showed that MEB-001 reported promising performance across key parameters, including:
- Sensitivity: 87% (95% CI 73-95%)
- Specificity: 72% (95% CI 66-77%)
- Positive Predictive Value (PPV): 35% (95% CI 27-45%)
- Negative Predictive Value (NPV): 97% (95% CI 93-99%)
These results provide considerable validation of MEB-001 and its ability in the screening and diagnosis of a current Major Depressive Episode (cMDE) in test subjects.
Management Commentary
Non-executive Chairman, David Trimboli, expressed excitement over the results, highlighting the effectiveness of MEB-001 in screening for cMDE. He noted the significant increase in sensitivity from 71% in Phase 1 to 87% in Phase 2, demonstrating the algorithm's improved ability to identify individuals with cMDE. The high NPV of 97% further validates MEB-001’s potential as a reliable screening test.
Trimboli emphasized that there is currently no screening undertaken for cMDE in sleep centers in the US or globally. The recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centers, marking a significant achievement in the company’s history.
The positive results from the Phase 2 SAMDE study are likely to have a favorable impact on TrivarX's stock, as investors recognize the commercial potential of MEB-001. The high sensitivity and specificity rates, along with the strong NPV, suggest that MEB-001 could become a valuable tool in the early detection and diagnosis of major depressive episodes. This could lead to increased adoption in clinical settings, driving revenue growth for TrivarX.
Investor Reaction:
Analysts are expected to react positively to the announcement, given the significant commercial opportunity presented by MEB-001. The lack of existing screening tools for cMDE in sleep centers globally highlights the potential market for TrivarX's algorithm. Investors may view this development as a strong indicator of the company's future growth prospects.
Conclusion:
Investors should keep an eye on TrivarX's progress as it moves towards commercializing MEB-001. The positive Phase 2 results mark a significant milestone for the company and suggest a promising future for its AI-driven depression screening tool. Staying informed on further developments will be crucial for making informed investment decisions.