$RAPH Raphael Pharmaceutical Announces Positive Proof-of-Concept Clinical Study Results for the Company’s Cannabinoid-Based Formula for the Treatment of Rheumatoid Arthritis
https://www.globenewswire.com/news-release/20...ritis.html
* Patients in Study Reported Lower Pain Levels, Better Sleep Quality, and Improved Wellbeing
* Disease Activity Score Decreased by 19.2%, Reflecting a Shift in Disease Activity from High to Moderate
* More than 80% of the Study’s Participants Expressed a Desire to Continue Using Product
NEW YORK, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Raphael Pharmaceutical Inc. (“Raphael Pharmaceutical” or the “Company”) (OTCQB: RAPH), a clinical-stage biotechnology company advancing a novel cannabinoid-based research platform, today announced positive proof-of-concept clinical study results for the Company’s cannabinoid-based formula for the management of rheumatoid arthritis (“RA”). Citruslabs, a leading contract research organization, successfully completed this proof-of-concept clinical study in the United States under Institutional Review Board (“IRB”) approval and in compliance with U.S. Food and Drug Administration (“FDA”) regulations.
Shlomo Pilo, Chairman and CEO of Raphael Pharmaceutical, commented, “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. Beyond rheumatoid arthritis, 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.”
Key Findings of the Proof-of-Concept Clinical Study
The single-group clinical trial evaluated the effects of Raphael Pharmaceutical’s highly purified cannabinoid-based formula on RA and involved 12 adult participants, each of whom used 0.5 mL of the formula daily over an eight-week period. The study results demonstrate promising efficacy, with significant improvements observed in critical health outcomes, including pain levels, sleep quality, and overall well-being. These benefits became evident as early as Week 4 and were sustained through the end of the trial. The study’s key findings:
Reduction in Disease Activity Score (“DAS28”): DAS28, a comprehensive metric assessing RA disease activity, declined by 19.2%, reflecting a shift in participants from high to moderate disease activity. DAS28 is a widely used measure of RA disease activity that combines the number of tender and swollen joints, levels of inflammation, and the patient's self-assessed health. A lower DAS28 score indicates reduced disease activity, and achieving low scores is a key goal in RA management. Of note, among the data:
Participants in remission increased from 0% at baseline to 16.67% by Week 8.
Low disease activity prevalence rose from 8.33% to 16.67%.
High disease activity prevalence decreased from 66.67% at baseline to 41.67%.
Improved Symptom Reporting:
Pain-related symptoms improved significantly, with participants reporting a reduction in negative pain outcomes from 75% at baseline to 50% by Week 8.
Morning stiffness also showed notable improvement, decreasing from 75% at baseline to 41.67% at Week 8.
Patient Satisfaction and Feedback:
83.33% of participants expressed a desire to continue using the product.
91.67% indicated they would recommend the formula to others living with RA.
Biomarker Analysis:
Although blood biomarker analysis did not reveal statistically significant changes, the overall findings emphasize the clinical potential of Raphael Pharmaceutical’s formula.
This study reinforces the Company’s extensive preclinical research, which suggests that Raphael Pharmaceutical’s formula effectively reduces key parameters of rheumatoid arthritis—thereby demonstrating potential to slow the progression of RA by acting as an anti-inflammatory agent.
Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from select non-psychoactive strains of cannabis with excellent anti-inflammatory potential. The formulation is designed to interact and communicate with the endocannabinoid system in the human body, activating cannabinoid receptors expressed by immune cells.
The Company intends to protect its intellectual property and highly purified cannabinoid formulation with a registered patent.
https://www.globenewswire.com/news-release/20...ritis.html
* Patients in Study Reported Lower Pain Levels, Better Sleep Quality, and Improved Wellbeing
* Disease Activity Score Decreased by 19.2%, Reflecting a Shift in Disease Activity from High to Moderate
* More than 80% of the Study’s Participants Expressed a Desire to Continue Using Product
NEW YORK, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Raphael Pharmaceutical Inc. (“Raphael Pharmaceutical” or the “Company”) (OTCQB: RAPH), a clinical-stage biotechnology company advancing a novel cannabinoid-based research platform, today announced positive proof-of-concept clinical study results for the Company’s cannabinoid-based formula for the management of rheumatoid arthritis (“RA”). Citruslabs, a leading contract research organization, successfully completed this proof-of-concept clinical study in the United States under Institutional Review Board (“IRB”) approval and in compliance with U.S. Food and Drug Administration (“FDA”) regulations.
Shlomo Pilo, Chairman and CEO of Raphael Pharmaceutical, commented, “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. Beyond rheumatoid arthritis, 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.”
Key Findings of the Proof-of-Concept Clinical Study
The single-group clinical trial evaluated the effects of Raphael Pharmaceutical’s highly purified cannabinoid-based formula on RA and involved 12 adult participants, each of whom used 0.5 mL of the formula daily over an eight-week period. The study results demonstrate promising efficacy, with significant improvements observed in critical health outcomes, including pain levels, sleep quality, and overall well-being. These benefits became evident as early as Week 4 and were sustained through the end of the trial. The study’s key findings:
Reduction in Disease Activity Score (“DAS28”): DAS28, a comprehensive metric assessing RA disease activity, declined by 19.2%, reflecting a shift in participants from high to moderate disease activity. DAS28 is a widely used measure of RA disease activity that combines the number of tender and swollen joints, levels of inflammation, and the patient's self-assessed health. A lower DAS28 score indicates reduced disease activity, and achieving low scores is a key goal in RA management. Of note, among the data:
Participants in remission increased from 0% at baseline to 16.67% by Week 8.
Low disease activity prevalence rose from 8.33% to 16.67%.
High disease activity prevalence decreased from 66.67% at baseline to 41.67%.
Improved Symptom Reporting:
Pain-related symptoms improved significantly, with participants reporting a reduction in negative pain outcomes from 75% at baseline to 50% by Week 8.
Morning stiffness also showed notable improvement, decreasing from 75% at baseline to 41.67% at Week 8.
Patient Satisfaction and Feedback:
83.33% of participants expressed a desire to continue using the product.
91.67% indicated they would recommend the formula to others living with RA.
Biomarker Analysis:
Although blood biomarker analysis did not reveal statistically significant changes, the overall findings emphasize the clinical potential of Raphael Pharmaceutical’s formula.
This study reinforces the Company’s extensive preclinical research, which suggests that Raphael Pharmaceutical’s formula effectively reduces key parameters of rheumatoid arthritis—thereby demonstrating potential to slow the progression of RA by acting as an anti-inflammatory agent.
Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from select non-psychoactive strains of cannabis with excellent anti-inflammatory potential. The formulation is designed to interact and communicate with the endocannabinoid system in the human body, activating cannabinoid receptors expressed by immune cells.
The Company intends to protect its intellectual property and highly purified cannabinoid formulation with a registered patent.
