お知らせ • Nov 19
Raphael Pharmaceutical Inc. Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis R Raphael Pharmaceutical Inc. announced the filing of a provisional patent application with the United States Patent and Trademark Office. The application covers the use of the Company's highly purified cannabinoid-based technology platform in the treatment of neutrophil-dominant autoimmune diseases, including its lead product candidate for rheumatoid arthritis (RA), as well as psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus with neutrophil involvement, and gout. Raphael previously announced positive proof-of-concept clinical study results for its cannabinoid-based formula for the management of RA. The study was successfully completed in the United States under Institutional Review Board ("IRB") approval and in compliance with U.S. Food and Drug Administration ("FDA") regulations. No adverse effects were reported throughout the trial. The provisional patent application, titled, "R Raphael Pharmaceutical Inc. /Rambam MedTech Formula for Treating Neutrophil-Dominant Autoimmune Diseases (including RA)" (No. 63/911,729), was filed jointly with the Medical Cannabis Research and Innovation Center (MCRIC) at Rambam Health Care Campus - one of the world's leading university hospitals. Raphael and Rambam have collaborated under a sponsored research agreement signed in 2019, granting Raphael exclusive access to Rambam's world-class cannabinoid research and development program, led by Dr. Igal Louria-Hayon, who serves as both Chief Technology Officer (CTO) of Raphael and Head of the Medical Cannabis Research and innovation Center at Rambam Health Care campus. Dr. Louria-Hayon is a global expert in cannabinoid research and cell-to-cell communication. Key Findings from the Proof-of-Concept Clinical Study: Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from the hemp plant, entirely free of psychoactive cannabis components, with exceptional anti-inflammatory potential. The formulation is administered orally and demonstrated no side effects. It is designed to interact with the human endocannabinoid system by activating cannabinoid receptors expressed on immune cells. In 2025, the Company announced positive Proof-of-Concept clinical results for the use of its cannabinoid-based formula in the treatment of RA. The eight-week IRB-approved study conducted in the United States showed significant improvements in pain, sleep quality, and overall well-being, which became evident as early as week four and persisted through the end of the trial. This included a reduction in DAS28 scores from high disease activity to moderate disease severity. お知らせ • Jan 07
Raphael Pharmaceutical Inc. Announces Positive Proof-Of-Concept Clinical Study Results for the Company's Cannabinoid-Based Formula for the Treatment of Rheumatoid Arthritis R Raphael Pharmaceutical Inc. 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. 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. The Company intends to protect its intellectual property and highly purified cannabinoid formulation with a registered patent. お知らせ • Jan 01
Raphael Pharmaceutical Inc. Receives Clinical Study Results After Successful Completion of a Proof-Of-Concept Clinical Study On December 23, 2024, Raphael Pharmaceutical Inc. (“Raphael” or the “Company”) received clinical study results after a successful completion of a proof-of-concept clinical study (the “Study”), evaluating the efficacy of the Company’s Cannabinoid based formula (“Raphael’s Formula”) in patients with active Rheumatoid Arthritis (“RA”). The single-group Study was managed by MindMate Inc./dba Citruslabs (“Citruslabs”) and conducted in Santa Monica, California, United States, under Institutional Review Board (“IRB”) approval, in compliance with the United States Food and Drug Administration (the “FDA”) regulations and in accordance with applicable industry standards and regulations. The Study evaluated the impact of Raphael’s Formula on RA related health outcomes in 12 adult participants, each of whom used 0.5 mL Raphael’s Formula product daily at home over an 8-week period, completed questionnaires and attended their local Quest Diagnostics Center for blood biomarker testing at designated intervals. According to the Study results, the questionnaires results demonstrated significant improvement in certain health parameters, including pain levels, sleep quality and overall well-being, with certain parameters remaining significantly improved through the end of the Study. The key findings from the Study results included a reduction in the Disease Activity Score (a comprehensive metric assessing RA disease activity) (“DAS28”) by 19.2%, reflecting a total decrease from high to moderate disease activity. A low DAS28 score indicates reduced disease activity and is a key goal in RA management. Additionally, the percentage of participants classified according to disease activity was evaluated and the findings included an increase in the percentage of participants classified as in remission from 0% at baseline to 16.67% at week 8, an increase in the percentage of participants classified as having low disease activity from 8.33% to 16.67% and a decreased in the percentage of participants classified as having high disease activity from 66.67% at baseline to 41.67% at week 8. The Study results also showed an improvement in health-related parameters, as evaluated through the questionnaires. For example, pain levels dropped from 75% participants reporting a negative result to 50% in week 8 and morning stiffness showed a notable reduction from 75% participants reporting such symptom at baseline to 41.67% at week 8. Additionally, participant perceptions were highly positive, with approximately 83.3% of participants willing to continue using the product and approximately 91.7% of participants indicating they would recommend Raphael’s Formula to others with RA. お知らせ • May 27
Raphael Pharmaceutical Inc. Contemplates Bankruptcy Raphael Pharmaceutical Inc. is contemplating filing for bankruptcy, as of May 25, 2023. According to company press release, the company said that additional funding will be required to complete the Company’s research and development and clinical trials, to attain regulatory approvals, to begin the commercialization efforts of the Company’s product and to achieve a level of sales adequate to support the Company’s cost structure. If such sufficient financing is not received timely, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated and would then need to pursue a plan to license its assets, seek to be acquired by another entity, cease operations or seek bankruptcy protection.