Breakthrough Clinical Results
4B Technologies announced positive topline results from a Phase 1 study of 4B03-04, a humanized monoclonal antibody for chronic pain. The trial demonstrated a favorable safety profile, predictable pharmacokinetics, and potential for monthly dosing. The drug uniquely targets pain signaling without affecting other nerve growth factor functions, minimizing side effects. 4B Technologies is advancing 4B03-04 into trials in osteoarthritis patients and plans for broader chronic pain patient populations in Phase 2.
Key Highlights
- Favorable safety profile of 4B03-04 observed in Phase 1 trial with no dose-limiting toxicities.
- Predictable pharmacokinetics supporting a potential monthly dosing regimen.
- Unique mechanism of action targeting pain signaling without disrupting other nerve growth factor functions.
- Initiation of trials in osteoarthritis patients and plans for Phase 2 studies in broader chronic pain populations.
Incidence and Prevalence
Latest Estimates of Chronic Pain Prevalence Globally
Chronic pain represents a major challenge for health authorities and healthcare providers at all levels. Recent studies provide varying estimates of its global prevalence.
General Population Prevalence
The reported prevalence of chronic pain ranges widely from 11% to 64% according to a 2022 study. In the European population, the prevalence has been estimated at approximately 19%, while disabling chronic pain affects around 7% of the German population.
A 2013 review of European Union data reported an average chronic pain prevalence of 27% in the general adult population, comparable to rates of other common chronic conditions.
Regional Variations
A Norwegian population study (HUNT 3 Study, 2022) found chronic pain prevalence of 36% among women and 25% among men.
In Japan, a 2016 survey revealed 39.3% of respondents met criteria for chronic pain (lasting ≥3 months).
A 2014 study in Libya found chronic pain prevalence of 25.0%, with pain more frequent in women.
In Hong Kong, a 2012 study reported 34.9% of adults experienced pain lasting more than 3 months.
A study from South Africa and Uganda found mild/moderate generalized pain in 34.5% of respondents and severe/extreme pain in 15.7%, with back pain specifically reported by 53.3%.
In the United States, analysis of NHANES data showed 27.1% of adult participants met the definition of chronic pain.
Special Populations
For hemophilia patients, a 2022 systematic review and meta-analysis found prevalence ranging from 17% to 84% across studies, with a pooled prevalence of 46%. Subgroup analysis showed 48% prevalence for all disease severities and 53% for severe patients only.
Among COVID-19 survivors, a 2022 cross-sectional study estimated chronic pain prevalence at 63.3%, with common sites being low back (37.8%), joints (28.9%), and neck (12.2%). Neuropathic pain was present in 24.4% of these patients.
In pediatric populations, a 2023 study found chronic pain occurred in 4.0% of their sample.
For people with opioid use disorder receiving opioid agonist treatment, a 2024 study revealed a pooled prevalence of 60.0% for current pain and 44.0% for chronic pain.
Risk Factors
Multiple studies identify common risk factors including female gender, older age, high BMI, low income, low educational level, unemployment, living alone, and lack of exercise. Smoking is also associated with higher prevalence.
Rural-urban disparities exist, with significant linear increases in chronic pain prevalence along the continuum from metropolitan to nonmetropolitan areas. These gaps are most pronounced among middle-aged (45-64) groups and non-Hispanic Whites.
Chronic pain has significant impacts on quality of life and is strongly associated with work incapacity, with the probability of receiving disability pension being four times higher for those affected.
Economic Burden
Economic Burden of Treating Chronic Pain in USA and Europe
United States
The economic burden of chronic pain in the United States is staggering, affecting an estimated 100 million people annually with costs ranging from $560 to $635 billion (2016 data). This estimate surpasses the costs associated with cancer, heart disease, and diabetes combined (2015). Historically, a 2010 study noted that in 1991, costs were estimated at approximately $65 billion annually, comparable to treating diabetes.
Recent data shows that individuals with high-impact chronic pain incur annual healthcare costs of $14,661 per person, more than double that of those with low-impact chronic pain ($6,371). For spine-related pain specifically, high-impact cases cost $5,979 annually versus $2,300 for low-impact cases (2019). Those with high-impact chronic spinal pain use spine-related opioids at a rate almost four times higher than those with low-impact pain (48.4% vs. 12.4%).
Patients with major depressive disorder and comorbid disabling chronic pain had higher medical service costs than other patient groups (2009). Despite these enormous costs, the treatment of chronic pain remains inadequate (2015).
Europe
In Europe, the total cost (including direct and indirect costs) of neuropathic pain per patient varies significantly by country (2016): - France: €10,313 (69% of total cost) - Germany: €14,446 (78%) - Italy: €9,305 (69%) - Spain: €10,597 (67%) - United Kingdom: €9,685 (57%)
Indirect costs (primarily sick leave) constitute the majority of expenses in all five countries: €7,098 in France, €11,232 in Germany, €6,382 in Italy, €7,066 in Spain, and €5,492 in the UK.
A 2022 Norwegian study estimated that chronic pain imposes a yearly burden of 4% of GDP, with annual costs as high as €12 billion. The study calculated an accumulated difference in costs between those with and without chronic pain from 2010 to 2016 of €55,003 per individual.
Global Patterns
Across both regions, indirect costs (productivity loss, social security payments) consistently exceed direct costs (prevention, diagnosis, therapy). In Norway, 80% of costs were attributed to productivity loss. Similarly, in Japan, those with fibromyalgia incurred indirect costs more than twice as high as those without (¥2,826,395 vs. ¥1,201,547) and direct costs nearly six times higher (¥1,941,118 vs. ¥335,140).
Multidisciplinary pain programmes significantly increase return-to-work rates, potentially reducing economic burden. A 2020 study showed that after multimodal pain therapy for children and adolescents, direct median costs decreased from 5619€ to 3262€ per year.
Interventional pain management (IPM) shows promise in reducing costs by shifting patients from higher-cost surgical procedures (2023). The IPM approach demonstrated lower risk-adjusted total costs than surgical interventions, driven by lower inpatient, outpatient, and post-acute care costs.
Despite the substantial economic impact, chronic pain has received disproportionally little attention in research and public policy, highlighting the need for intensive pharmacoeconomic investigations.
Investigational Compound 4B03-04: Clinical Trials Beyond Chronic Pain
Based on a comprehensive review of available clinical trial data, there is no information available regarding the investigational compound 4B03-04 being trialed for indications other than chronic pain.
The compound 4B03-04 does not appear in current clinical trial registries for any therapeutic indications, including chronic pain. Without verified clinical trial data, it is not possible to determine:
- Additional indications beyond chronic pain
- Intervention models being utilized
- Study designs implemented in trials
- Dosing regimens or administration protocols
- Patient populations being targeted
- Clinical phases of development
- Therapeutic approaches being evaluated
If this compound exists, it may be in pre-clinical development or using an alternative designation in clinical trial registries. Researchers interested in this compound should consult official clinical trial databases or contact the developing pharmaceutical company directly for the most current information on its development status and therapeutic applications.
For patients and clinicians seeking information about novel treatments for chronic pain or other conditions, it is recommended to follow established medical literature and official clinical trial registries for evidence-based therapeutic options.