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.

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

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

BACKGROUNDDespite 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.OBJECTIVETo evaluate the efficacy of DMN patches in enhancing drug delivery and improving clinical outcomes in psoriatic plaques.METHODSA 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.RESULTSA 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.CONCLUSIONThe 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 REGISTRATIONClinicalTrials.gov Identifier: NCT02955576.

01 Mar 2024·International Immunopharmacology

Fourth dose of microneedle array patch of SARS-CoV-2 S1 protein subunit vaccine elicits robust long-lasting humoral responses in mice

Article

Author: Shin, Juyeop ; Baldanti, Fausto ; Khan, Muhammad S ; Huang, Shaohua ; Gambotto, Andrea ; Kenniston, Thomas W ; Cassaniti, Irene ; Ferrari, Alessandro ; Kim, Eun ; An, Eunjin ; Jeong, Dohyeon ; Han, Donghoon

The COVID-19 pandemic has underscored the pressing need for safe and effective booster vaccines, particularly in considering the emergence of new SARS-CoV-2 variants and addressing vaccine distribution inequalities. Dissolving microneedle array patches (MAP) offer a promising delivery method, enhancing immunogenicity and improving accessibility through the skin's immune potential. In this study, we evaluated a microneedle array patch-based S1 subunit protein COVID-19 vaccine candidate, which comprised a bivalent formulation targeting the Wuhan and Beta variant alongside a monovalent Delta variant spike proteins in a murine model. Notably, the second boost of homologous bivalent MAP-S1(WU + Beta) induced a 15.7-fold increase in IgG endpoint titer, while the third boost of heterologous MAP-S1RS09Delta yielded a more modest 1.6-fold increase. Importantly, this study demonstrated that the administration of four doses of the MAP vaccine induced robust and long-lasting immune responses, persisting for at least 80 weeks. These immune responses encompassed various IgG isotypes and remained statistically significant for one year. Furthermore, neutralizing antibodies against multiple SARS-CoV-2 variants were generated, with comparable responses observed against the Omicron variant. Overall, these findings emphasize the potential of MAP-based vaccines as a promising strategy to combat the evolving landscape of COVID-19 and to deliver a safe and effective booster vaccine worldwide.

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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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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Drug(Targets)	Indications	Global Highest Phase

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
RapMed-2003	Obesity More	Preclinical

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