Raphael Pharmaceutical Announces Positive Proof-of-Concept Clinical Study Results for the Company’s Cannabinoid-Based Formula for the Treatment of Rheumatoid Arthritis  

Rhea-AI Summary

Raphael Pharmaceutical (OTCQB: RAPH) announced positive proof-of-concept clinical study results for its cannabinoid-based formula treating rheumatoid arthritis (RA). The study, conducted by Citruslabs under IRB approval, showed significant improvements in 12 adult participants over eight weeks.

Key findings include a 19.2% reduction in Disease Activity Score (DAS28), shifting patients from high to moderate disease activity. The percentage of participants in remission increased from 0% to 16.67%, while high disease activity cases decreased from 66.67% to 41.67%. Pain-related symptoms improved, with negative pain outcomes dropping from 75% to 50%, and morning stiffness decreased from 75% to 41.67%.

83.33% of participants expressed desire to continue treatment, and 91.67% would recommend it to others. The company aims to potentially partner with a global biopharma company for drug delivery format development and commercialization.

Positive

• Disease Activity Score (DAS28) decreased by 19.2%
• 16.67% of participants achieved remission from 0% baseline
• Pain-related symptoms reduced from 75% to 50%
• 83.33% of participants want to continue treatment
• 91.67% would recommend the treatment to others

Negative

• Blood biomarker analysis showed no statistically significant changes
• Small study size of only 12 participants limits statistical significance
• FDA approval still required for commercialization

* 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.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic autoimmune disease characterized by, among other symptoms, chronic joint pain and inflammation, fever, and fatigue. The rheumatoid arthritis patient population is large and growing. According to a report published in The Lancet Rheumatology on September 25, 2023, the number of individuals globally with rheumatoid arthritis will grow by approximately 80% from 18 million in 2020 to an estimated 32 million in 2050. Despite the prevalence of this condition, the Company believes that there is an unmet clinical need to address the symptoms and suffering of these patients within the current treatment landscape. The Company believes that its formula has the potential to become, if approved by the U.S. Food and Drug Administration (“FDA”), an attractive treatment option to existing rheumatoid arthritis therapies, some of which can produce pronounced side effects, be prohibitively expensive and/or deliver inadequate efficacy.

About Raphael Pharmaceutical Inc.

Raphael Pharmaceutical Inc. (“Raphael”) (OTCQB: RAPH) is a clinical-stage biotechnology company focused on advancing a novel cannabinoid-based research platform for the treatment of various inflammatory diseases. Raphael’s lead product candidate is a highly purified cannabinoid formulation specifically developed for the treatment of rheumatoid arthritis.

For more information, please visit https://www.raphaelpharmaceutical.com/.

Cautionary Note Regarding Forward-Looking Statements

Certain statements contained in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are predictive in nature and are identified by the use of the terms “will,” “look forward to” and “aim,” and similar words indicating possible future expectations, events or actions. Such forward-looking statements are based on current expectations, assumptions, estimates and projections about our business and our industry, and are not guarantees of our future performance. These statements are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond our ability to control or predict, which may cause actual events to be materially different from those expressed or implied herein. The Company has provided additional information about the risks facing our business in its most recent annual report on Form 10-K, and any subsequent periodic and current reports on Forms 10-Q and 8-K, filed by it with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statement was made and are expressly qualified in their entirety by the cautionary statements set forth herein and in the filings with the Securities and Exchange Commission identified above, which you should read in their entirety before making an investment decision with respect to our securities. We undertake no obligation to update or revise any forward-looking statements contained in this release, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Contact:

The Equity Group        
Kalle Ahl, CFA                
T: (303) 953-9878        
kahl@equityny.com

Devin Sullivan                
T: (212) 836-9608        
dsullivan@equityny.com

FAQ

What were the key results of RAPH's rheumatoid arthritis clinical trial?

The trial showed a 19.2% reduction in Disease Activity Score (DAS28), with 16.67% of participants achieving remission. Pain-related symptoms improved from 75% to 50%, and 83.33% of participants wanted to continue treatment.

How many patients participated in RAPH's 2025 proof-of-concept study?

The study included 12 adult participants who used 0.5 mL of the cannabinoid-based formula daily over an eight-week period.

What is the market potential for RAPH's rheumatoid arthritis treatment?

According to The Lancet Rheumatology, the global rheumatoid arthritis patient population is expected to grow from 18 million in 2020 to 32 million by 2050, representing an 80% increase.

What are RAPH's commercialization plans for their RA treatment?

Raphael Pharmaceutical plans to potentially partner with a larger global biopharma company through licensing to develop a patentable drug delivery format and advance manufacturing, marketing, and distribution.

When did RAPH's rheumatoid arthritis treatment start showing benefits?

Benefits became evident as early as Week 4 of the trial and were sustained through the end of the eight-week study period.