Raphael Pharmaceutical Announces Positive Proof-of-Concept Clinical Study Results for the Company’s Cannabinoid-Based Formula for the Treatment of Rheumatoid Arthritis
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.
Raphael Pharmaceutical (OTCQB: RAPH) ha annunciato risultati positivi di uno studio clinico proof-of-concept per la sua formula a base di cannabinoidi per il trattamento dell'artrite reumatoide (RA). Lo studio, condotto da Citruslabs con approvazione dell'IRB, ha mostrato significativi miglioramenti in 12 partecipanti adulti nel corso di otto settimane.
I principali risultati includono una riduzione del 19,2% del Disease Activity Score (DAS28), che ha spostato i pazienti da un'attività di malattia elevata a una moderata. La percentuale di partecipanti in remissione è aumentata dallo 0% al 16,67%, mentre i casi di alta attività della malattia sono diminuiti dal 66,67% al 41,67%. I sintomi legati al dolore sono migliorati, con gli esiti negativi del dolore che sono scesi dal 75% al 50%, e la rigidità mattutina è diminuita dal 75% al 41,67%.
Il 83,33% dei partecipanti ha espresso il desiderio di continuare il trattamento, e il 91,67% lo raccomanderebbe ad altri. L'azienda punta a una potenziale partnership con una società biofarmaceutica globale per lo sviluppo e la commercializzazione di formati di somministrazione del farmaco.
Raphael Pharmaceutical (OTCQB: RAPH) anunció resultados positivos de un estudio clínico proof-of-concept para su fórmula a base de cannabinoides para el tratamiento de la artritis reumatoide (AR). El estudio, realizado por Citruslabs con la aprobación del IRB, mostró mejoras significativas en 12 participantes adultos durante ocho semanas.
Los hallazgos clave incluyen una reducción del 19,2% en el Disease Activity Score (DAS28), trasladando a los pacientes de una alta a una actividad moderada de la enfermedad. El porcentaje de participantes en remisión aumentó del 0% al 16,67%, mientras que los casos de alta actividad de la enfermedad disminuyeron del 66,67% al 41,67%. Los síntomas relacionados con el dolor mejoraron, con los resultados negativos por dolor reduciéndose del 75% al 50%, y la rigidez matutina disminuyó del 75% al 41,67%.
El 83,33% de los participantes expresó su deseo de continuar el tratamiento, y el 91,67% lo recomendaría a otros. La empresa tiene como objetivo asociarse potencialmente con una compañía biofarmacéutica global para el desarrollo y comercialización de formatos de entrega del medicamento.
라파엘 제약 (OTCQB: RAPH)은 류머티즘 관절염 (RA) 치료를 위한 카나비노이드 기반 포뮬러의 긍정적인 개념 증명 임상 연구 결과를 발표했습니다. 이 연구는 IRB 승인을 받은 시트러스랩스(Citruslabs)에서 진행되었으며, 8주 동안 12명의 성인 참가자에서 상당한 개선을 보여주었습니다.
주요 결과에는 질병 활동 점수 (DAS28)의 19.2% 감소가 포함되어 있으며, 환자들은 높은 질병 활동에서 중간 질병 활동으로 이동했습니다. 완치된 참가자의 비율은 0%에서 16.67%로 증가했으며, 높은 질병 활동 사례는 66.67%에서 41.67%로 감소했습니다. 통증 관련 증상도 개선되어, 부정적인 통증 결과가 75%에서 50%로 감소했으며, 아침 강직은 75%에서 41.67%로 줄어들었습니다.
참가자의 83.33%는 치료를 계속하고 싶다고 표현했으며, 91.67%는 이를 다른 사람에게 추천할 것이라고 응답했습니다. 회사는 약물 전달 형식 개발 및 상용화를 위해 글로벌 생명공학 회사와의 파트너십을 목표로 하고 있습니다.
Raphael Pharmaceutical (OTCQB: RAPH) a annoncé des résultats positifs d'une étude clinique proof-of-concept pour sa formule à base de cannabinoïdes traitant l'arthrite rheumatoïde (AR). L'étude, menée par Citruslabs sous approbation de l'IRB, a montré des améliorations significatives chez 12 participants adultes sur une période de huit semaines.
Les résultats clés comprennent une réduction de 19,2% du Disease Activity Score (DAS28), déplaçant les patients d'une activité de maladie élevée à modérée. Le pourcentage de participants en rémission est passé de 0% à 16,67%, tandis que les cas d'activité élevée de la maladie ont diminué de 66,67% à 41,67%. Les symptômes liés à la douleur se sont améliorés, avec des résultats négatifs de douleur passant de 75% à 50%, et la raideur matinale diminuant de 75% à 41,67%.
83,33% des participants ont exprimé le désir de continuer le traitement, et 91,67% le recommanderaient à d'autres. L'entreprise vise à établir un partenariat potentiel avec une entreprise biopharmaceutique mondiale pour le développement et la commercialisation de formats d'administration de médicaments.
Raphael Pharmaceutical (OTCQB: RAPH) gab positive Ergebnisse einer klinischen Proof-of-Concept-Studie zu ihrer cannabinoidbasierten Formel zur Behandlung von rheumatoider Arthritis (RA) bekannt. Die Studie, die von Citruslabs unter Genehmigung des IRB durchgeführt wurde, zeigte signifikante Verbesserungen bei 12 Erwachsenen über einen Zeitraum von acht Wochen.
Zu den wichtigsten Ergebnissen gehört eine 19,2%ige Reduzierung des Disease Activity Score (DAS28), die die Patienten von einer hohen zu einer moderaten Krankheitsaktivität verschob. Der prozentuale Anteil der Teilnehmer in Remission stieg von 0% auf 16,67%, während die Fälle mit hoher Krankheitsaktivität von 66,67% auf 41,67% sanken. Schmerzhafte Symptome verbesserten sich, wobei die negativen Schmerzresultate von 75% auf 50% sanken und die Morgensteifheit von 75% auf 41,67% abnahm.
83,33% der Teilnehmer äußerten den Wunsch, die Behandlung fortzusetzen, und 91,67% würden sie anderen empfehlen. Das Unternehmen plant eine potenzielle Partnerschaft mit einem globalen Biopharmaunternehmen zur Entwicklung und Vermarktung von Arzneimittelabgabesystemen.
- 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
- 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
* More than
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 to16.67% by Week 8. - Low disease activity prevalence rose from
8.33% to16.67% . - High disease activity prevalence decreased from
66.67% at baseline to41.67% .
- Participants in remission increased from
- Improved Symptom Reporting:
- Pain-related symptoms improved significantly, with participants reporting a reduction in negative pain outcomes from
75% at baseline to50% by Week 8. - Morning stiffness also showed notable improvement, decreasing from
75% at baseline to41.67% at Week 8.
- Pain-related symptoms improved significantly, with participants reporting a reduction in negative pain outcomes from
- 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
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
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