Our mission at Pax Neuroscience is to incorporate the biology of depression in the design of agents to improve and transform the standard of care for clinical depression and related mood disorders.

Pax’s technology platform analyzes the biology of depression and mood disorders, and the mechanism of action of antidepressants to inform decisions of patients and physicians about the diagnosis and treatment of depression, as well as to improve antidepressant drug development.

MoodMarkDx and MoodMarkRx are the first evidence-based tests to provide unbiased, biological evidence of depression diagnosis and treatment-response prediction derived from physiological changes specific to clinical depression. U.S. and international patents protect Pax’s biomarker assays for antidepressant drug development and Pax’s blood tests.

Value Proposition

Pax’s technology provides value to stakeholders including: patients, pharmaceuticals, doctors, payers, employers and the economy.  Please find below a brief description of some of the key value propositions for each entity:

  • Patients: Pax’s technology improves the quality of care and enhances patient outcomes, lowers costs and reduces the stigma of depression while improving compliance
  • Pharmaceutical/Biotechnology companies: MoodMark assists in target identification and validation, mechanism determination and validation of a preclinical hypothesis. In clinical trials MoodMarkDx can improve trial design and trial data, demonstrate clear clinical impact, make better therapies, lower R&D costs, derisk investment in development of new drugs and boost the odds of FDA approval
  • Physicians: Confirms clinical diagnosis and improves overall standard and quality of care
  • Payers: Reduces healthcare spend on inaccurate diagnoses and ineffective drugs
  • Employers: Screening for depression in work place can improve productivity and save money. Fewer layoffs of unproductive workers; fewer sick days; less disability awarded; etc.
  • Health Care System: Lower cost of health care burden by 11%, or $9.6 billion; lower burden on social services; decrease unnecessary hospitalizations and high ER costs
  • Social Services: Trim Social security disability, unemployment, Medicare and Medicaid costs and social impact

Clinical Depression

True clinical depression is a mood disorder in which feelings of sadness, loss, anger, or frustration interfere with everyday life for a long period of time and so impair function that it requires clinical intervention. Clinical depression varies in severity. The most severe type is major depressive disorder (MDD).

The World Health Organization (WHO) states that as of 2018, depression is the leading cause of disability worldwide. Depression adversely affects the course and outcome of common chronic conditions, such as arthritis, asthma, cardiovascular disease, cancer, diabetes, and obesity, increasing morbidity and mortality.

Depression is costly to society, employers, individual patients and families. One reason for the high cost is that most patients endure lengthy and ultimately unsuccessful antidepressant trials before a successful medication is identified through ‘trial and error.’ Secondly, but as important, is the fact that depression diagnosis is a subjective clinical decision based on self-reports of symptoms and limited observations, often in a 15 minute appointment. Current rating scales are not sufficiently accurate and most times are not used in primary care where the majority of depression is diagnosed and treated.

The goal of treatment is remission from all symptoms. But, the treatment is frequently ineffective and/or inadequate. In fact, after an adequate initial trial of a single antidepressant, failure (defined as not reaching full remission: 60%-70%) is twice as likely as success (remission: 30%). When response (at least 50% reduction in symptoms) is considered a “success” instead of remission, the “success” rate can climb to 40% to 60%. However, most patients do not find a 50% reduction of presenting symptoms to be a “success.”

Accurate recognition and effective treatment can relieve the personal, social and economic burden of depression on the individual, society and the healthcare system.

Our Technology Platform

Pax products target clinical depression due to the serious unmet need that is well documented, expensive and growing.

Pax’s lead product is a simple blood test- the first evidence-based test to provide unbiased, biological evidence of depression diagnosis and treatment-response prediction derived from physiological changes specific to clinical depression.

Dr. Mark Rasenick, Pax Founder, developed a patented biomarker assay platform technology based on the location of a protein called Gs alpha (Gsα) in blood cell membranes providing quantitative biological evidence of depression and treatment efficacy. MoodMarkDx and MoodMarkRx Proof-of-concept has been established in both animal and human cells.

Pax is developing a platform (MoodMarkPredict) based on this technology that utilizes a patient’s blood cells, subjected to a panel of drugs and drug combinations, that will determine the appropriate course of initial therapy.

MoodMarkDx and MoodMarkRx will also guide Pharma in the selection of subjects for clinical trials. Additionally, Pax has developed a pre-clinical screen (MoodMarkR&D) that allows Pharma to make initial decisions about the possible antidepressant efficacy of pipeline products.

Our Business

The Company has two distinct business segments:

1) The diagnostic blood test: commercialization of a patented biomarker-based blood test to assist physician diagnosis and treatment efficacy for each patient diagnosed and in treatment for depression. A variant of this is in development for a prospective predictive screen using a patient’s leukocytes to guide treatment options, including drug combinations

2) The drug development services business: offers pharmaceutical and biotechnology companies the opportunity to work with Pax to analyze antidepressant compounds in early stage discovery and in antidepressant clinical trials. In clinical trials, the blood test can streamline recruitment by identifying potential subjects who are and are not biologically depressed, identify responders and non-responders, provide quantitative data, produce greater efficiencies in development, lower costs, and develop better drugs. Preclinical neurobiology and central nervous system(CNS) drug discovery solutions allow the Company to work with pharmaceutical companies to identify and validate targets, select new compounds, and reposition or repurpose shelved compounds.

Revenues generated from drug development services are intended to bootstrap the continued development of the blood test assay for the consumer and pharmaceutical markets; and, novel new antidepressant development.

Key Markets and Financial Projections

1. Biomarker for Depression Diagnosis and Treatment Efficacy: The U.S. patient care market for our  biomarker-based blood test is estimated at $5B. The market size estimate includes diagnostics for diagnosis and efficacy in all cases of clinical depression including the newly diagnosed and patients with treatment-resistant depression; complex patients, and patients with comorbid diseases exacerbated by depression, in both inpatient and outpatient settings. Management believes there are further growth opportunities in this market. The government extension of parents’ insurance to children until the age of 26 will be an important event for our blood test since the average age of onset for major depression  is the mid 20’s, and depression is the leading cause of disability in ages 15-45. The non-Asia, ex-U.S. market represents a potential additional $2.6B opportunity

2. Novel Antidepressant Compounds: Approximately $5B in drugs is coming off patent by 2013. New competition will come from Astra Zeneca, Otsuka, Takeda, Cephalon, Shire, Sumitomo and Novartis. Pax has a patent pending on new antidepressants based on the technology platform.

3. R&D Services: There is high demand for biomarkers in drug discovery. The fastest growing segment is the application of biomarker testing in clinical trials, which will grow by 23.5%, reaching US$1.8B by 2012. Biomarker-based diagnostics are driving personalized medicine, which in turn, is powering drug development. Pax is growing its service-based preclinical and clinical business for pharmaceutical companies to improve antidepressant R&D and lower costs. The service market is estimated at $154M.

Milestones

Biomarker Research and Development:

  • Conduct human proof of concept clinical studies
  • Strategize and begin FDA approval process
  • Develop a high throughput assay (HTP) for scalability

Corporate Development:

  • Build out the management team
  • Protect intellectual property and seek new patent opportunities
  • Create and initiate reimbursement strategy

Business Development: Collaborations to develop new antidepressants and further technology development

Sales and Marketing: Grow Drug and Biotech R&D services contracts

Biomarker Assay:PAX plans to conduct two human proofs of concept studies designed to demonstrate clinical value.  In addition, the blood test is under study in a Phase IV clinical trial in Europe with a major pharmaceutical company. The results of this trial are expected in 2013. Management predicts the results of these three studies will confirm that the location of Gsα is both a state marker for depression and a biomarker for antidepressant response.

Corporate Development: Pax intends to build out the management team, continue to protect our intellectual property and seek new patent opportunities; and create a reimbursement strategy.

Sales: Pax is working to secure additional Pharma and Biotech R&D contracts and build our services pipeline.