A Randomized, Double Blind, Placebo-controlled, Multiple-dose, Parallel Phase Ⅰ Study to Evaluate Safety and Compare the Immune Stimulating Efficacy of "DF19001" in Dermatophagoides Farinae Sensitized Allergic Rhinitis Volunteers

When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.

Start Date20 Jan 2022

Sponsor / Collaborator

RAPHAS Co., Ltd.

100 Clinical Results associated with RAPHAS Co., Ltd.

0 Patents (Medical) associated with RAPHAS Co., Ltd.

Literatures (Medical) associated with RAPHAS Co., Ltd.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Inactivated mycobacterium paragordonae delivered via microneedle patches as a novel tuberculosis booster vaccine

Article

Author: Kim, Bum-Joon ; Yoon, Kiyoung ; Kim, Hwa-Jung ; Jin, Juyoung ; Back, Yong Woo ; Bae, Sung Min ; Jeong, Dohyeon ; Lee, Moonsu ; Jang, In-Taek

Tuberculosis (TB) remains a significant global health challenge with approximately 8.2 million new cases reported in 2023, despite the century-old Bacillus Calmette-Guérin (BCG) vaccine. BCG's protective efficacy diminishes over time, especially against pulmonary TB in adults. This study evaluates ethanol-inactivated Mycobacterium paragordonae (M.pg) delivered via Microneedle Array Patches (MAPs) as a novel booster strategy to enhance BCG vaccination efficacy. Various inactivation methods including heat treatment, formalin, and ethanol were compared, with ethanol-inactivated M.pg selected for optimal preservation of morphology and immunologically significant proteins. MAPs were fabricated using the droplet extension technique (DEN). Immunological assessment was conducted in a mouse model receiving either BCG alone or BCG followed by one or two administrations of inactivated M.pg MAP. Protective efficacy was evaluated through M. tuberculosis H37Rv challenge. Ethanol inactivation uniquely preserved morphology and maintained protein integrity, particularly Ag85B. Two administrations of inactivated M.pg following BCG priming significantly enhanced protective immune responses compared to BCG alone, inducing strong Th1-polarized immunity characterized by elevated IFN-γ, TNF-α, and IL-2 production in both CD4+ and CD8+ T cells. This vaccination strategy effectively generated effector memory T cells in lung and spleen, contributing to significant reduction in bacterial burden following challenge, with the BCG+Inactivated M.pg^2nd group demonstrating the greatest reduction. Inactivated M.pg delivered via microneedle patches represents an effective booster strategy for enhancing BCG-induced protection against tuberculosis, with a two-dose schedule demonstrating optimal efficacy. This approach combines the safety advantages of an inactivated vaccine with the practical benefits of MAPs, addressing key limitations of tuberculosis vaccination strategies.

01 Feb 2025·JOURNAL OF CONTROLLED RELEASE

White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin

Review

Author: Henry, Sebastien ; Coulman, Sion A ; Hernandez, Carmen Amelia Rodriguez ; Henke, Stefan ; Zehrung, Darin ; Dick, Lisa ; Alali, Mohammed ; Eakins, Michael N ; Speaker, Tycho Joseph ; Shin, Juyeop ; Forster, Angus Harry ; Frivold, Collrane ; Jarrahian, Courtney ; Lewis, Hayley ; Strasinger, Caroline ; Creelman, Benjamin Paul ; Burke, Matthew Douglas ; Prausnitz, Mark R ; Dul, Maria ; Park, Jung-Hwan ; Gilbert, Philippe-Alexandre ; Robinson, David Kenneth ; Birchall, James C ; Taylor, Kevin M G ; Donnelly, Ryan F ; Hunt, Desmond ; Mistilis, Jessica Joyce ; Ameri, Mahmoud

The COVID-19 pandemic has accelerated pre-clinical and clinical development of microneedle-based drug delivery technology. However the regulatory science of this emerging dosage form is immature and explicit regulatory guidance is limited. A group of international stakeholders has formed to identify and address key issues for the regulatory science of future products that combine a microneedle device and active pharmaceutical ingredient (in solid or semi-solid state) in a single entity that is designed for application to the skin. Guided by the principles of Quality by Design (QbD) and informed by consultation with wider stakeholders, this 'White Paper' describes fundamental elements of the work in an effort to harmonise understanding, stimulate discussion and guide innovation. The paper discusses classification of the dosage form (combination/medicinal product), the regulatory nomenclature that is likely to be adopted and the technical vocabulary that best describes its form and function. More than twenty potential critical quality attributes (CQAs) are identified for the dosage form, and a prioritisation exercise identifies those CQAs that are most pertinent to the dosage form and that will likely require bespoke test methods (delivered dose, puncture performance) or major adaptions to established compendial test methods (dissolution). Hopefully the work will provide a platform for the development of dosage form specific guidance (from regulatory authorities and/or international pharmacopoeias), that expedites clinical translation of safe and effective microneedle-based products.

01 Jan 2025·Annals of Dermatology

Additional Use of Hyaluronic Acid-Based Dissolving Microneedle Patches to Treat Psoriatic Plaques: A Randomized Controlled Trial

Article

Author: Jeong, Do Hyeon ; Kim, Gyong Moon ; Lee, Ji Hae ; Bae, Jung Min ; Kim, Ji Yoon ; Lee, Moon-Su ; Ju, Hyun Jeong

BACKGROUND:

Despite advances in systemic targeted therapies, topical agents remain the primary treatment for localized psoriasis. However, their therapeutic effects are often delayed and unsatisfactory. The dissolving microneedle (DMN) patch, a novel transdermal drug delivery system, enhances the absorption of topical agents through micro-channels.

OBJECTIVE:

To evaluate the efficacy of DMN patches in enhancing drug delivery and improving clinical outcomes in psoriatic plaques.

METHODS:

A prospective, randomized, split-body study was conducted to verify the efficacy of additional use of DMN patches after topical agent application in psoriasis treatment. Patients with mild psoriasis were enrolled and 6 paired lesions per patient were randomized into 3 groups: ointment-only, ointment-with-no needle patch, and ointment-with-DMN patch. Lesions were treated with a topical agent (betamethasone and calcipotriol) once daily for 2 weeks. Modified psoriasis area and severity index (mPASI) scores were measured weekly. In vitro and ex vivo experiments were performed to confirm micro-channel formation, microneedle dissolution, and drug penetration enhancement.

RESULTS:

A total of 132 paired lesions from 22 patients were analyzed. The ointment-with-DMN patch group showed significantly improved mPASI scores (80.4%±20.5%; 5.42→1.06) compared to the ointment-with-no needle patch (64.6%±33.0%; 4.94→1.68) (p<0.05) and ointment-only groups (55.5%±31.4%; 5.00→2.15) (p<0.001). In vitro studies demonstrated 2.1-fold enhanced drug delivery with DMN patches, while ex vivo histological analysis confirmed micro-channel formation. No adverse events, including infection or psoriasis exacerbation, were observed.

CONCLUSION:

The DMN patch is an effective adjunctive tool that enhances transdermal drug delivery and improves therapeutic outcomes in psoriatic plaques, particularly those refractory to topical agents.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT02955576.

News (Medical) associated with RAPHAS Co., Ltd.

08 Apr 2024

·www.koreabiomed.com

Daewon Pharm applies for trial of patch-type obesity treatment

Daewon Pharmaceutical has taken the first step toward conducting clinical trials to develop a semaglutide-based obesity treatment as a patch. Daewon Pharm and Raphas said Tuesday they had completed the investigational new drug application for a phase 1 clinical trial of DW-1022, a microneedle patch obesity treatment candidate jointly developed by the two companies. Daewon and Raphas have been researching to develop Novo Nordisk's Wegoby (semaglutide) injection into a microneedle patch. The joint development was selected as a key technology development project for the bio-industry by the Ministry of Trade, Industry, and Energy in 2020. The two companies also completed the registration of a joint patent for a microneedle patch with synthetic semaglutide last month. Daewon has been developing raw materials equivalent to new drugs by converting genetically recombinant semaglutide into synthetic peptides and conducting nonclinical studies of finished drugs. Raphas has been developing formulations of finished drugs for microneedle patches. Based on the research, Daewon will lead the phase 1 trial. Semaglutide was developed to increase insulin secretion in diabetic patients and approved by the U.S. Food and Drug Administration as a treatment for diabetes in 2017 and as a treatment for obesity in 2021. However, existing self-injectable drugs have the disadvantage of causing pain and secondary infections, resulting in high patient burden and medical waste. Daewon expects DW-1022 to be a patch that can be easily applied, eliminating the hassle of direct injection for patients. Utilizing fine needles of 1mm or less is also expected to have an excellent delivery rate in the body and fewer skin side effects.“ For chronic diseases that must be managed for a long time, such as diabetes and obesity, the convenience of taking medication is an important factor,” a Daewon official said. “We expect this to be an innovative treatment that will greatly increase absorption and convenience compared to existing injections."

100 Deals associated with RAPHAS Co., Ltd.

100 Translational Medicine associated with RAPHAS Co., Ltd.

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Pipeline

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

RapMed-1504	Osteoporosis More	Phase 1
RapMed-2102	Influenza, Human More	Clinical
Semaglutide (Daewon Pharm) ( GLP-1R )	Obesity More	IND Application
RapMed-1904	Tuberculosis More	Preclinical
RapMed-2002	COVID-19 More	Preclinical

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