Antidepressant Drug Research & Development Services

Pax’s technology platform is presently available to Pharma to quickly confirm a clinical diagnosis of depression and assess antidepressant activity to identify responders and nonresponders in clinical trials. The goal is to shorten time to market, add additional sales and patent opportunities and create greater efficiencies in drug development.

Clinical Trial

Use of the MoodMarkDX blood test in antidepressant clinical trials will help streamline recruitment to eliminate potential subjects who are not biologically depressed, improve efficiencies, reduce costs, provide quantitative end points, predict treatment response and characterize and identify responders and nonresponders

In clinical trials, subject recruitment is often based on self-described symptoms and rating scales leading to inclusion of patients who may not be biologically depressed. The result is higher costs and less reliable data. Use of the Pax biomarker assay can confirm a clinical diagnosis and identify responders and nonresponders, potentially reducing the placebo effect. Targeting biologically depressed patients can improve success rates; improve chances for regulatory approval and lower R&D costs.

Preclinical

Use of the MOODMARKSCREEN biomarker assay in drug discovery will identify potential compounds for future development to maximize resource utilization

In preclinical development, use of the biomarker in vitro assay can identify and evaluate the most effective targets, allow for study of the mechanism of action, and maximize resource utilization.  Additionally, the assay can identify new uses for previously approved drugs; synergistic relationships between drug combinations; and salvage data from failed trials turning past failures into future successes by re-submitting drugs for approval for smaller subsets of patients.

Antidepressant drug discovery is at a crossroads. Antidepressant efficacy clinical trials are extremely expensive (involving chronic treatment of hundreds of patients) and high risk (large placebo responses cause many trials to fail). Without a biological target and no way to identify patients who are depressed, or will respond, it is difficult to prove that an antidepressant works. This is a significant drawback in an era when insurers and other healthcare payers want to see clear value for their money.

Companies want to know as early as possible in the development process whether or not a drug could be effective and whether or not to move forward or cut losses. There exists an urgent need to increase effectiveness and probability of success by integrating biomarkers as early as possible into the research and development process.

The motivation is to “fail early and fail cheap” as the cost of failure is high. The FDA estimates that just a 10% improvement in the ability to predict drug failures before clinical trials could save $100 million in development costs per drug.

The cell-based MOODMARKSCREEN can be employed to validate the preclinical hypothesis and identify putative compounds for targeted future development, without regulatory approval.