Breakthrough Clinical Results
Artelo Biosciences announced positive results from its first-in-human Phase 1 study of ART26.12, a novel, orally administered FABP5 inhibitor for persistent pain. The study demonstrated excellent safety and a predictable pharmacokinetic profile in 49 healthy volunteers. No drug-related adverse events were observed. ART26.12's mechanism of action involves modulating lipid signaling pathways, offering a potential non-opioid solution for the large chronic pain market. A Phase 2 Multiple Ascending Dose study is planned for the fourth quarter of 2025.
Key Highlights
- Positive first-in-human data for ART26.12, a novel non-opioid pain treatment.
- Excellent safety profile observed with no drug-related adverse events.
- Predictable pharmacokinetic profile confirming dose-dependent, linear absorption.
- A wide safety margin observed, supporting potential dose titration for efficacy.
Incidence and Prevalence
Global Prevalence and Impact of Persistent Pain
Persistent pain represents a major public health issue that is estimated to affect approximately a quarter of the world's population. Chronic pain has emerged as one of the main health problems in modern society due to its high prevalence and significant impact on quality of life.
Regional Prevalence
In Western countries, the prevalence of chronic pain affects between 20-30% of the population. More specifically:
Spain
- A study in Spain found the prevalence of chronic pain was 25.9% (95% CI: 24.8-26.9)
- Non-chronic continuous pain affected 7.7% (95% CI: 7.1-8.3) of the population
- Women presented a higher prevalence of both chronic pain (30.5% vs. 21.3%) and non-chronic continuous pain (8.8% vs. 6.6%)
- Chronic pain was more common in people between 55 and 75 years old (30.6%, 95% CI = 28.6-32.6%)
- Non-chronic continuous pain most affected the population between 18 and 34 years old (11.2%, 95% CI = 9.6-12.7%)
- The lumbar region was the most frequent pain site (58.1%)
- Chronic pain affects one in four Spanish people and impairs mental, physical and social health
China
- Up to 2016, the ratio of pain incidence in China was over 30%
- Unlike Spain, the proportion of males having chronic pain (33.86%) was higher than that of females (29.53%)
- The average age of participants with pain was 45.02 ± 15.07 years
United States
- Over 120 million Americans report experiencing pain in the past 3 months
- Among these individuals, 50 million report chronic pain
- 17 million report pain that limits daily life or work activities on most days (i.e., high-impact chronic pain)
Impact on Health and Quality of Life
Chronic pain is associated with: - Greater frequency of limitations on activities of daily living - More anxiety and depression - Worse quality of life
In China specifically: - About 43.042% of patients thought that pain resulted in sleep disorder - 38.99% thought that it causes anxiety - About 33% thought depression and irritable bowel was the result of their pain
Musculoskeletal pain conditions in particular are a major contributor to: - Global disability - Health care costs - Poor quality of life
These findings highlight that persistent pain is a widespread global health challenge affecting significant portions of populations across different countries, with varying demographic patterns but consistently negative impacts on quality of life and daily functioning.
Economic Burden
Economic Burden of Persistent Pain in the USA
The economic impact of persistent and chronic pain poses a substantial burden on individual patients, their families, employers, economies and societies in general. According to the latest estimates from the context, the annual economic cost of pain in the United States is as high as $635 billion.
Chronic pain affects an estimated 100 million people a year in the United States and costs society anywhere from $560 to $635 billion annually. This represents a significant increase from earlier estimates - in 1991, costs were estimated to be approximately $65 billion annually, comparable to the cost of treating diabetes.
The economic consequences of inadequately treated chronic pain translates into lost work days, overutilization of health care resources (excess hospitalizations, surgical procedures and inappropriate medications) and other out-of-pocket patient expenses.
Cost Breakdown by Pain Interference Level
Research shows that even "a little bit" of chronic pain-related interference was associated with a $2,498 increase in total adjusted expenditures over no pain interference and a $1,008 increase over nonchronic pain interference.
More severe pain leads to higher costs: - Moderate chronic pain-related interference was associated with a $3,707 increase in expenditures over no pain interference and a $2,218 increase over nonchronic interference - Severe chronic pain-related interference was associated with a $5,804 increase in expenditures over no pain interference and a $4,315 increase over nonchronic interference
Types of Expenditures
Expenditure increases were most pronounced for inpatient and hospital outpatient expenditures compared to other types of health care expenditures. Health care costs due to chronic pain are particularly high during the first year after pain onset, and remain high compared with health care costs before pain onset.
The majority of chronic pain patients incur the costs of alternative treatments, adding to the overall economic burden.
Broader Economic Impact
The impact of persistent pain is recognized as greater than most other health conditions, due to its effects on rates of absenteeism, reduced levels of productivity and increased risk of leaving the labour market, as well as the costs to the healthcare system and other government agencies.
Chronic pain causes production losses at work, as well as impairment of non-work activities.
International Perspective
While the context provides limited information on Europe, it does mention that in Vietnam, the median cost of treatment was between 150 and 250 USD, representing a significant economic burden.
Future Directions
The management of chronic pain is remarkably complex and resource intensive. There is a clear need for intensive pharmacoeconomic investigations, specifically evaluating costs related to chronic pain and the associated treatment modalities.
Drug used in other indications
ART26.12 Clinical Trials Information
Based on the provided context, there is no information available about ART26.12 clinical trials for persistent pain or any other indications. The context explicitly states that no information about "ART26.12" or any trials related to this specific intervention could be found in the provided texts.
Without available information in the context, it is not possible to provide details about: - Clinical indications beyond chronic persistent pain syndrome - Intervention methodologies, dosing regimens, or administration protocols - Phases of clinical development for various therapeutic indications
The context indicates that none of the provided texts mention this treatment or medication.