Research & Development Services
Using a Blood-Based Biomarker to
Bring Better Treatments Forth Faster
Pax's technology platform is CURRENTLY 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, enhance sales with superior demonstration of efficacy, and identify new targets and IP 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 making clearer determinations of efficacy.
For Preclinical Research
The MoodMark® biomarker in vitro assay can identify and evaluate the most effective targets and also allow for study of the mechanism of action. It can also assist in identifying new anti-depressant uses for previously approved drugs and synergistic anti-depressant effects in novel combination therapies. It could even transform previous failed trials into successes by enabling the re-submission for approval in a smaller subsets of patients.
For Clinical Trials
MoodMark® will provide quantitative endpoints and predict treatment response. Subject recruitment via rating scale leads to the inclusion of subjects who are not biologically depressed, resulting in higher costs and less reliable data. Targeting biologically-validated depressed patients can improve trial success rates as well as regulatory approval likelihood, while lowering R&D costs. Using MoodMark® to confirm a clinical diagnosis and identify responders and non-responders will minimize the distortion of placebo effects.
Guiding Drug Discovery Beyond the Current Stagnation
Antidepressant efficacy clinical trials are extremely expensive (involving chronic treatment of hundreds of patients) and high risk (with large placebo response causing many to fail). Without a biological target and without a precise way to identify patients who are clinically depressed, or how their depression responds, 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.