Cannabinoid-Based Formula Demonstrates Proof-of-Concept for Treating RA

Raphael Pharmaceuticals has announced proof-of-concept data supporting the development of its cannabinoid-based formula for the potential treatment of rheumatoid arthritis (RA).1

The findings are from a single-group clinical trial that evaluated 0.5 mL of the cannabinoid-based formula daily over 8 weeks in 12 adult participants. The investigators observed significant improvements observed in critical health outcomes, including pain levels, sleep quality, and overall well-being, signaling promising efficacy of the formula as early as week 4 and sustained throughout the trial period.

“The results of our proof-of-concept clinical study are very promising and underscore the potential of our formula to improve quality of life for those suffering from rheumatoid arthritis. We intend to build on this study to create a new, improved, and cost-effective treatment option for members of the large and growing rheumatoid arthritis patient population. Our go-forward pathways include, among other options, potentially partnering with a larger global biopharma company through licensing to develop a patentable drug delivery format for our formula and to advance the manufacturing, marketing and distribution of the final product,” Shlomo Pilo, Chairman and CEO of Raphael Pharmaceutical, said in a statement.1

Specifically, investigators observed a 19.2% reduction in Disease Activity Score (DAS28): DAS28, from high to moderate disease activity. The proportion of participants in remission increased from 0% at baseline to 16.67% by Week 8. Additionally, low disease activity prevalence rose from 8.33% to 16.67%, and high disease activity prevalence decreased from 66.67% at baseline to 41.67% by week 8.1

Looking at patient reported outcomes, participants reported a reduction in negative pain outcomes from 75% at baseline to 50% by Week 8 and a reduction in morning stiffness from 75% at baseline to 41.67% at Week 8. Notably, 83.33% of participants wanted to continue using the product and 91.67% indicated they would recommend it to others living with RA. However, no statistically significant changes have been seen on blood biomarker analysis.1

“Beyond RA, we believe that our highly purified cannabinoid-based technology platform may have broader applications to other chronic conditions linked to inflammation, such as autoimmune disease and chronic lung inflammation. We intend to advance our research in these areas as well,” Pilo added.1

The development of a cannabinoid-based formula builds on a growing trend of cannabis use for pain management symptoms in RA and other rheumatic diseases in recent years. Recent studies, such as one led by Kevin F. Boehnke, PhD, out of University of Michigan, have supported the efficacy and growing prevalence of medical cannabis (MC) for pain management. Boehnke and colleagues found that in 763 participants with rheumatic diseases surveyed, 62.5% (n = 477) reported substituting MC products for medications, including nonsteroidal anti-inflammatory drugs (54.7%), opioids (48.6%), sleep aids (29.6%), and muscle relaxants (25.2%).2

Most participants that substituted medications decreased or ceased medication use. Participants’ reasons for substituting included fewer adverse events (AEs) with MC compared with medication (39%), better symptom management (27%), fewer AEs (12%), other (9%), ability to obtain (8%), and greater social acceptance (5%). A higher proportion of substitutors used inhalation routes than those who did not (P <.001).2

REFERENCES

1. Raphael Pharmaceutical Announces Positive Proof-of-Concept Clinical Study Results for the Company’s Cannabinoid-Based Formula for the Treatment of Rheumatoid Arthritis. News release. Raphael Pharmaceuticals. January 7, 2025. https://www.globenewswire.com/news-release/2025/01/07/3005316/0/en/Raphael-Pharmaceutical-Announces-Positive-Proof-of-Concept-Clinical-Study-Results-for-the-Company-s-Cannabinoid-Based-Formula-for-the-Treatment-of-Rheumatoid-Arthritis.html

2. Boehnke KF, Scott JR, Martel MO, et al. Substituting Medical Cannabis for Medications Among Patients with Rheumatic Conditions in the United States and Canada. ACR Open Rheumatol. Published online September 5, 2024. doi:10.1002/acr2.11717