OA MEDICAL

Company

Focused on inflammation and pain.
Leadership team with extensive, senior level, global experience in academia & biopharma.

Mission

Discovering & developing innovative and transformative drug therapies to satisfy the unmet needs for effective treatment of inflammation & chronic pain in widespread disease conditions.

Our lead clinical stage compound is CLX-002, now entering Phase 2 human clinical trials for osteoarthritis (OA).

The Problem:
Inflammation is the underlying cause of many diseases

OA osteoarthritits, a common medical condition with unmet needs for satisfactory treatments. OA is too often dismissed as a “normal” part of aging. In fact, there is nothing “normal” about OA.

The true picture: OA is a serious disease, not just a “normal” part of aging.

Significant health consequences
Progressive loss of function, decreased mobility and reduced “quality of life” caused by chronic pain, associated inflammation and progressive joint structure damage
Catastrophic outcomes for the individuals, their families and society in general.

OA-associated pain, inflammation and progressive joint damage actually result in:

“Premature” ageing with crucial loss of everyday functioning and quality of life

OA is the one of the highest causes of work loss

“Premature” mortality by inducing or sustaining other serious conditions such as obesity, diabetes and hypertension

Those with OA have a greater risk of dying than their age- and gender-matched peers.
For example, US adults with symptomatic knee OA were found to be 23% more likely to die prematurely than people free from OA, independent of age, sex and race.

OA has proven frustratingly difficult to manage and cure

No new oral drugs have been approved specifically for OA since Vioxx (withdrawn in 2004 because of serious safety issues) and Celebrex over 20 years ago.
The mainstays of drug therapy remain the NSAIDs (ibuprofen, naproxen, diclofenac etc.), Celebrex and opioids, which have limited therapeutic effect and serious side effects.

Unmet Medical Need in Arthritic Diseases: the Damage Done

OA, most common form of arthritis: a degenerative joint disease, most frequently of knee, hip & hands.
Progressive breakdown & loss of articular cartilage in synovial joints.
Most common symptoms: joint pain, stiffness, swelling, loss of mobility.
Fastest growing cause of disability worldwide.

The Numbers & Facts

Chronic Pain and the Need for New Analgesic Drugs

Chronic pain is a major symptom of not only osteoarthritis (OA), but also several other widespread common medical conditions. The most common pain locations are the back, the knee, the hip and foot.
Chronic pain is defined as pain that persists either beyond the normal healing time of an injury or for longer than three months. (NIH)
Chronic pain has a complex set of possible causes. It is a medical condition that can affect every aspect of a person’s life. It can contribute to considerable loss of both physical and emotional function. Those suffering from chronic pain experience diminishing levels of activity, productivity, social relationships and overall well-being. Moreover, they have an increased risk of premature mortality.
Because of the high prevalence of chronic pain, the high level of patient dissatisfaction with existing treatments and on opioids as generally the best current option for relief, despite their known risks, there is an urgent need to develop safe and effective analgesics without the liability of misuse, abuse and addiction.
Most recently, however the heterogeneity of clinical pain conditions together with the complexity and multiplicity of underlying pathophysiological mechanisms has made it difficult to identify biological targets that have proven fruitful for drug development and commercialization. These issues have led to most drug development efforts being diverted to reformulations for validated existing drug classes despite their known efficacy or safety limitations.

The Problem: Opioid Use in Chronic Pain

Treatment guidelines include the use of strong opioids for moderate-to-severe pain.
However, about 60-70% of CP patients are dissatisfied with their treatment underscoring the prevalence of refractory pain (i.e., pain that cannot be treated with the available medication).
The use of prescribed opioids has contributed, at least in part, to an unprecedented opioid epidemic & the opioid crisis equal about 5% of the US GDP.
Initiation and progression of opioid abuse are due to several factors, including ease of access and dose escalation to obtain the desired effects (tolerance).

Current Opioid Crisis

Although opioids play an important role in the practice of medicine, particularly in critical care & pain management; long-term use often leads to tolerance and addiction.
The opioid crisis is currently an epidemic & continues to be a major concern of authorities.
Cost to society is huge.
Drug overdose is the leading cause of accidental death in the US. According to US government’s most recent surveys: 11 million Americans misused opioids last year.
2.1 million had an opioid use disorder due to prescription opioids.

Resolution of Chronic Inflammation and Pain: A New Therapeutic Frontier

Our Lead Product: CLX-002 safe and ready for phase 2 clinical studies

Novel, first-in class
Oral, once-daily

Potential benefits:

Very safe and effective vs. current oral Rx drugs (NSAIDs & opioids)

Superior analgesic properties & no risk of addiction
Superior anti-inflammatory properties
Treats moderate-to-severe pain unlike NSAIDs
Reduces disability and co-morbidities
Mitigates disease progression
Reduces enormous burden of costs of OA

References and methodologies used

1 — Level of satisfaction with treatment: www.cdc.gov/nchs/products/databriefs/db390.htm

2 — Estimated number of patients in advanced countries:
For US: Patients with all forms of arthritis; data from CDC at https://www.cdc.gov/arthritis/data_statistics/national-statistics.html Percentage of patients with OA = 60%. (Source: Lawrence RC et al. Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States, Part II. Arthritis Rheum. 2008: 58(1): 26–35
Europe: 2004 OA population based on citation in Kingsbury et al 2014 (Source: Kingsbury SR, Gross HJ, Isherwood G, Conaghan PG. Osteoarthritis in Europe; impact on health status, work productivity and use of pharmacotherapies in five European countries. Rheumatology. 2014; 53(5): 937-47)
For Canada, Australia & New Zealand: pro-rated from US data based on relative overall population size
For Japan: Based on number of patients with OA of knee (25 million) in 2008. (Source. Yoshimura N. Epidemiology of osteoarthritis in Japan: the ROAD study. Clin Calcium. 2011 Jun;21(6):821-5). Growth from that base mirrors the US.

3 — Gaskin DJ, Richard P. The economic costs of pain in the United States. Pain. 2012; 13(8): 715-724

4 — Barbour KE, Helmick CG, Boring M, Brady TJ. Prevalence of Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation. CDC MMWR. 2017; 66(9): 246–253

5 — Burden of cost:
OA: estimates from CDC https://www.cdc.gov/arthritis/data_statistics/cost.htm
Estimate of direct costs adjusted to 2020$.
CVD & stroke: estimates from CDC https://www.cdc.gov/chronicdisease/resources/publications/factsheets/heart-disease-stroke.htm,.
Last reviewed 10/7/2020.
Cancer: CDC https://www.cdc.gov/chronicdisease/resources/publications/factsheets/cancer.htm. Last reviewed September 21, 2020), Mariotto AB et al. Projections of the cost of cancer care in the United States.: 2010–2020. J Natl Cancer Inst. 2011; 103:117–128. Bradley CJ et al. Productivity costs of cancer mortality in the United States: 2000–2020. J Natl Cancer Inst. 2008; 100:1763–1770.
Diabetes : CDC for 2017 https://www.cdc.gov/chronicdisease/resources/publications/factsheets/diabetes-prediabetes.htm
Estimate of direct costs adjusted to 2020$

Contact

Corporate Offices

➝ Montréal, Québec — Canada
➝ Bowie, Maryland — USA

info@oamedic.com