Raphas Rewrites the Rules of Allergy Immunotherapy—From Injections to a Patch
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[FNEplus = Mi-joo Lee] Raphas Co., Ltd., a company specializing in microneedle technology and led by CEO Do-Hyun Jung, announced on the 17th that it has successfully completed a Phase 1 clinical trial of DF19001 (RapMed1506-11-A), an allergic rhinitis immunotherapy developed in a patch formulation.
This clinical trial was conducted using an allergen active pharmaceutical ingredient (API) that Raphas’ subsidiary Prolagen received approval for from Korea’s Ministry of Food and Drug Safety (MFDS) in 2019, which was subsequently developed into a microneedle formulation. DF19001 is the world’s first microneedle patch-type allergen immunotherapy, and is significant in that it overcomes the limitations of conventional injectable formulations while presenting a new treatment paradigm.
In this clinical trial, a total of 54 subjects were administered the investigational drug. All adverse events observed were mild or Grade 1 in severity, and no serious adverse events (SAEs) occurred, demonstrating excellent overall safety and tolerability.
In terms of efficacy, statistically significant increases in antigen-specific immunoglobulins sIgG4 and sIgE, which are known to play important roles in alleviating allergic responses, were observed in a specific dose group (Cohort 3) compared with the placebo group. These results strongly suggest the potential for meaningful immune response induction at this dose level.
Across the treatment groups, trends toward symptom reduction and dose-dependent trends (p for trend) were observed. In addition, results from the skin prick test (SPT) showed consistent reductions in skin reactions across all treatment groups, securing exploratory signals of potential improvement that could be confirmed as clinical efficacy in subsequent trials.
This Phase 1 trial enrolled 54 subjects and was conducted over 16 weeks, during which the investigational product and placebo were administered five times per week. Safety and tolerability were evaluated as primary endpoints, while efficacy was assessed as a secondary endpoint.
Through a self-administration approach over the 16-week period, the trial demonstrated significant advantages in patient adherence and convenience associated with the microneedle patch formulation compared with existing therapies.
Allergen immunotherapy typically requires long-term treatment over 2 to 3 years, and conventional injectable formulations require frequent hospital visits. DF19001, however, was developed as a self-applicable patch, maximizing patient convenience.
In addition, microneedle patches are known to carry a lower risk of injection-related adverse effects, such as anaphylactic shock, suggesting favorable safety outcomes. In preclinical animal studies, Raphas confirmed that DF19001 achieved the same level of immune activation with only one-tenth of the dose used in conventional injections. This finding suggests the possibility of reducing side effects while maintaining therapeutic efficacy.
DF19001 is an immunotherapy designed to address the underlying causes of allergic diseases. The successful completion of this Phase 1 trial once again validates Raphas’ microneedle technology and significantly raises expectations for the future commercialization of DF19001.
A Raphas representative stated, “Based on these results, the company plans to submit applications for additional clinical trials to the MFDS and has entered into a contract with a contract research organization (CRO). We are also actively pursuing technology partnerships with domestic and global pharmaceutical companies, with the ultimate goal of providing a new treatment option to allergy patients worldwide.”
The representative added, “DF19001 delivers drugs through the skin layer, which is rich in dendritic cells and T cells involved in immune responses. Its mechanism of action is similar to that of a vaccine patch, and this achievement is expected to serve as an important milestone for our ongoing development of microneedle patch vaccines.”
Meanwhile, according to the latest report from IMARC Group, the global allergy therapeutics market was valued at approximately USD 23.5 billion in 2024, of which the immunotherapy segment accounted for approximately USD 3.4 billion. As the prevalence of allergic diseases continues to increase worldwide, demand is expected to grow at a compound annual growth rate (CAGR) of approximately 8.3% through 2033.
In South Korea, allergic diseases are particularly common, with approximately 5 million patients reported in 2021 according to data from the Health Insurance Review and Assessment Service. This increase in patient numbers is driving growth in the related market.
Currently, oral antihistamines account for the largest share of the market. However, interest is growing in immunotherapies that address the root causes of disease, rather than providing symptomatic relief. In particular, the development of patient-friendly treatments such as sublingual immunotherapy (SLIT) is further accelerating market growth.
According to Global Market Insights, the allergy therapeutics market was valued at approximately USD 13.7 billion (KRW 18.5 trillion) in 2024 and is expected to reach approximately USD 19.9 billion (KRW 26.9 trillion) by 2034.
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