Research & Development Services
How a Blood-Based Biomarker Will
Bring Better Treatments Forth Faster
Pax's technology platform is available to pharmaceutical research and development teams. This advancement will quickly confirm a clinical diagnosis of depression to stratify subjects and and assess antidepressant activity, identify responders and non-responders in clinical trials to bring greater efficiency to drug development, quicken approval and enhance sales with superior demonstration of efficacy, and identify new targets and patent opportunities.
New areas of exploration in anti-depressant treatment, such as device-based and psychedelic approaches, break the research paradigm of placebo comparison altogether, with experiential effects that are not possible to convincingly substitute. Enhancing the quantifiability of change is in these cases even more vital in determining efficacy.
For Preclinical Research
Use of the MoodMark® 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.
Use of the MoodMark® biomarker the assay assists in identifying 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.
For Clinical Trials
Use of the MoodMark® blood test in antidepressant clinical trials will streamline recruitment. By eliminating non-biologically depressed subjects we improve efficiencies, reduce costs, provide quantitative end points, predicting treatment response, characterizing and identifying responders and non-responders.
In clinical trials, subject recruitment based on self-described symptoms and rating scales leads to inclusion of patients who may not be biologically depressed. The result is higher costs and less reliable data. Use of Pax's MoodMark® biomarker assay can confirm a clinical diagnosis and identify responders and non-responders, potentially reducing placebo effect.
Targeting biologically-validated depressed patients can improve success rates, improve chances for regulatory approval, and lower R&D costs.
Guiding Drug Discovery Beyond the Current Stagnation
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 demand 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 MoodMark® can be employed to validate the preclinical hypothesis and identify putative compounds for targeted future development, prior to regulatory approval.