Raphael Pharmaceutical Files Patent for THC-Free Cannabinoid Therapy Targeting Rheumatoid Arthritis
Key Insights
Raphael Pharmaceutical (search) filed a provisional patent application with the USPTO for its THC-free and CBD-free cannabinoid platform to treat neutrophil-dominant autoimmune diseases including rheumatoid arthritis (search).
The company's proof-of-concept clinical study demonstrated significant improvements in pain, sleep quality, and overall well-being in RA patients over eight weeks with no reported adverse effects.
The patent application covers treatment applications for multiple autoimmune conditions including psoriatic arthritis (search), inflammatory bowel disease (search), systemic lupus erythematosus (search), and gout (search).
Raphael Pharmaceutical (search) Inc. has filed a provisional patent application with the United States Patent and Trademark Office for its innovative cannabinoid-based technology platform targeting neutrophil-dominant autoimmune diseases. The clinical-stage biotechnology company announced the filing covers its lead product candidate for rheumatoid arthritis (search) (RA) as well as applications for psoriatic arthritis (search), inflammatory bowel disease (search), systemic lupus erythematosus (search) with neutrophil involvement, and gout (search).
The patent application, titled "Raphael Pharmaceutical (search), 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, described as one of the world's leading university hospitals.
Positive Clinical Study Results Drive Patent Filing
The patent filing follows positive proof-of-concept clinical study results for Raphael's cannabinoid-based formula in RA management. The study was completed in the United States under Institutional Review Board approval and in compliance with FDA regulations, with no adverse effects reported throughout the trial.
The eight-week IRB-approved study demonstrated significant improvements in pain, sleep quality, and overall well-being in RA patients. These improvements became evident as early as week four and persisted through the end of the trial. Notably, the study showed a reduction in DAS28 scores from high disease activity to moderate disease severity.
"Based on our research to date, we believe Raphael Pharmaceutical (search)'s proprietary formula has the potential to offer a safe and cost-effective option that significantly reduces inflammation, and severe symptoms for millions of people suffering from rheumatoid arthritis (search)," said Dr. Igal Louria-Hayon, who serves as both Chief Technology Officer of Raphael and Head of the Medical Cannabis Research and Innovation Center at Rambam Health Care Campus.
Unique Cannabinoid Platform Technology
Raphael Pharmaceutical (search)'s approach utilizes a highly purified cannabinoid formulation (search) derived from the hemp plant that is entirely free of psychoactive cannabis components, including both THC and CBD. The formulation demonstrates exceptional anti-inflammatory potential and is administered orally with no reported side effects.
The technology is designed to interact with the human endocannabinoid system (search) by activating cannabinoid receptors (search) expressed on immune cells. This mechanism of action represents a novel approach to treating inflammatory autoimmune conditions.
Strategic Partnership and Commercial Development
The collaboration between Raphael and Rambam operates under a sponsored research agreement signed in 2019, granting Raphael exclusive access to Rambam's cannabinoid research and development program. Dr. Louria-Hayon, recognized as a global expert in cannabinoid research and cell-to-cell communication, leads this program.
"The filing of this provisional patent application represents a major milestone for Raphael and our partner Rambam," said Shlomi Pilo, President and CEO of Raphael Pharmaceutical (search). "It is a critical step forward in protecting our innovative cannabinoid-based technology platform and moving toward the initial launch of our commercial product 'RaphaWell (search),' which is designed for targeted, orally accessible delivery to patients within the RA community in the U.S."
Broader Therapeutic Applications
The scope of the provisional patent reflects the potential for broader applications beyond rheumatoid arthritis (search). Dr. Louria-Hayon noted that the highly purified cannabinoid platform may have applications in other chronic inflammatory conditions, as evidenced by the patent's coverage of multiple neutrophil-dominant autoimmune diseases.
The company's lead product candidate, RaphaWell (search), represents a highly purified non-psychoactive cannabinoid formulation (search) developed specifically for rheumatoid arthritis (search) treatment, with the goal of providing targeted, orally accessible delivery to patients.