Bio-Convert Receives Positive Feedback from The Danish Medicine Agency (DKMA) on its Lead Drug Candidate, QR-02 for Oral Leukoplakia
Bio-Convert, a subsidiary of Nordicus Partners (OTCQB: NORD), has received positive feedback from the Danish Medicine Agency (DKMA) regarding its lead drug candidate QR-02 for oral leukoplakia treatment. The feedback suggests a clear pathway toward First in Human trials, potentially without requiring animal studies.
The company has developed a proprietary mucoadhesive oral topical formulation featuring extended retention time of 12-24 hours in the oral cavity, compared to conventional formulations lasting only 15-20 minutes. QR-02 uses imiquimod as its active ingredient, which is already approved for treating Actinic Keratosis, External Genital Warts, and Superficial Basal Cell Carcinoma. The treatment aims to cure and reduce dysplasia levels in oral leukoplakia patients.
The First in Human trial is expected to commence by the end of 2025.
Bio-Convert, una filiale di Nordicus Partners (OTCQB: NORD), ha ricevuto feedback positivi dall'Agenzia Danese dei Medicinali (DKMA) riguardo al suo principale candidato farmaceutico QR-02 per il trattamento della leucoplachia orale. Il feedback suggerisce un chiaro percorso verso le sperimentazioni cliniche di Fase I, potenzialmente senza la necessità di studi sugli animali.
L'azienda ha sviluppato una formulazione topica orale mucoadesiva proprietaria con un tempo di ritenzione prolungato di 12-24 ore nella cavità orale, rispetto alle formulazioni convenzionali che durano solo 15-20 minuti. QR-02 utilizza imiquimod come principio attivo, già approvato per il trattamento della cheratosi attinica, delle verruche genitali esterne e del carcinoma basocellulare superficiale. Il trattamento mira a curare e ridurre i livelli di displasia nei pazienti con leucoplachia orale.
La sperimentazione clinica di Fase I è prevista per l'inizio della fine del 2025.
Bio-Convert, una subsidiaria de Nordicus Partners (OTCQB: NORD), ha recibido comentarios positivos de la Agencia Danesa de Medicamentos (DKMA) sobre su principal candidato a fármaco QR-02 para el tratamiento de la leucoplasia oral. Los comentarios sugieren un camino claro hacia los ensayos en humanos, potencialmente sin necesidad de estudios en animales.
La empresa ha desarrollado una formulación tópica oral mucoadhesiva patentada que presenta un tiempo de retención prolongado de 12-24 horas en la cavidad oral, en comparación con las formulaciones convencionales que solo duran de 15 a 20 minutos. QR-02 utiliza imiquimod como su ingrediente activo, que ya está aprobado para el tratamiento de la queratosis actínica, las verrugas genitales externas y el carcinoma basocelular superficial. El tratamiento tiene como objetivo curar y reducir los niveles de displasia en pacientes con leucoplasia oral.
Se espera que el ensayo en humanos comience a finales de 2025.
Bio-Convert는 Nordicus Partners (OTCQB: NORD)의 자회사로, 덴마크 의약품청 (DKMA)으로부터 구강 백반증 치료를 위한 주요 약물 후보인 QR-02에 대한 긍정적인 피드백을 받았습니다. 이 피드백은 동물 연구 없이도 인간 임상 시험으로 나아갈 수 있는 명확한 경로를 제시합니다.
회사는 구강 내에서 12-24시간 동안 지속되는 점착성 구강 국소 제형을 개발하였으며, 이는 기존 제형이 15-20분만 지속되는 것과 비교됩니다. QR-02는 이미 외부 생식기 사마귀, 표재성 기저세포암 및 광선각화증 치료를 위해 승인된 이미퀴모드를 활성 성분으로 사용합니다. 이 치료는 구강 백반증 환자의 이형성증 수준을 치료하고 감소시키는 것을 목표로 합니다.
인간 임상 시험은 2025년 말에 시작될 것으로 예상됩니다.
Bio-Convert, une filiale de Nordicus Partners (OTCQB: NORD), a reçu des retours positifs de l'
L'entreprise a développé une formulation topique orale muco-adhésive propriétaire avec un temps de rétention prolongé de 12 à 24 heures dans la cavité buccale, par rapport aux formulations conventionnelles qui ne durent que 15 à 20 minutes. QR-02 utilise imiquimod comme principe actif, déjà approuvé pour le traitement de la kératose actinique, des verrues génitales externes et du carcinome basocellulaire superficiel. Le traitement vise à guérir et à réduire les niveaux de dysplasie chez les patients atteints de leucoplasie orale.
Les essais cliniques de phase I devraient commencer d'ici la fin de 2025.
Bio-Convert, eine Tochtergesellschaft von Nordicus Partners (OTCQB: NORD), hat positives Feedback von der Dänischen Arzneimittelbehörde (DKMA) zu ihrem Hauptkandidaten QR-02 zur Behandlung von oraler Leukoplakie erhalten. Das Feedback deutet auf einen klaren Weg zu den ersten klinischen Studien am Menschen hin, möglicherweise ohne die Notwendigkeit von Tierversuchen.
Das Unternehmen hat eine proprietäre mucoadhesive orale Topikumsformulierung entwickelt, die eine verlängerte Verweildauer von 12-24 Stunden in der Mundhöhle aufweist, im Vergleich zu herkömmlichen Formulierungen, die nur 15-20 Minuten halten. QR-02 verwendet Imiquimod als Wirkstoff, der bereits zur Behandlung von aktinischer Keratose, äußeren Genitalwarzen und oberflächlichem Basalzellkarzinom zugelassen ist. Die Behandlung zielt darauf ab, die Dysplasie bei Patienten mit oraler Leukoplakie zu heilen und zu reduzieren.
Die erste klinische Studie am Menschen wird voraussichtlich Ende 2025 beginnen.
- Received positive DKMA feedback potentially eliminating need for animal studies
- Proprietary formulation with 12-24 hour retention time vs. 15-20 minutes for conventional treatments
- Active ingredient (imiquimod) already approved for other conditions
- Clear pathway to First in Human trials by end of 2025
- Clinical trials haven't started yet, indicating long path to potential commercialization
BEVERLY HILLS, California, April 03, 2025 (GLOBE NEWSWIRE) -- Bio-Convert A/S (“Bio-Convert”), a subsidiary of Nordicus Partners Corporation (OTCQB: NORD) (“Nordicus” or the “Company”), a financial consulting company specializing in supporting Nordic and U.S. life sciences companies in establishing themselves in the U.S. market, announces it has received positive and constructive feedback from the Danish Medicine Agency (“DKMA”) for its lead drug candidate, QR-02 for the treatment of oral leukoplakia.
DKMA’s feedback paves the way toward a First in Human trial, with a high likelihood of animal studies rendered dispensable for the proposed formulation and route of application.
Allan Wehnert, CEO and Founder of Bio-Convert commented: “DKMA gave valuable and clear guidance, providing us with a clear pathway towards the initiation of the First in Human trial with QR-02 which is expected to start end of 2025.”
Bio-Convert has developed a unique and proprietary mucoadhesive oral topical formulation for the treatment of oral leukoplakia with moderate to severe dysplasia.
The unique feature of the gel formulation (QR-02) is its ability to stay in the oral cavity for 12-24 hours, which is significantly longer than conventional gel formulations which only stay in the oral cavity for 15-20 minutes due to the large washout effect caused by mouth saliva. The active ingredient is imiquimod which is approved for the treatment of Actinic Keratosis, External Genital Warts and Superficial Basal Cell Carcinoma (sBCC).
The goal for QR-02 is to cure and reduce the level of dysplasia so patients with oral leukoplakia potentially can be cured from their disorder.
For further information, contact:
Mr. Henrik Rouf
Chief Executive Officer
hr@nordicuspartners.com
Tel +1 310 666 0750
About Bio-Convert
Bio-Convert’s mission is to develop the preferred treatment for oral leukoplakia. Our innovative therapeutic agent, QR-02, uses a novel drug delivery technology, that enables more precise, effective and efficient treatment.
About Nordicus Partners Corporation
Nordicus Partners Corporation is the only U.S. publicly traded business accelerator and holding company for Nordic life sciences companies. Leveraging decades of combined management experience in domestic and global corporate sectors, Nordicus excels in corporate finance activities including business and market development, growth strategies, talent acquisition, partnership building, capital raising, and facilitating company acquisitions and sales. In 2024, Nordicus acquired
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FAQ
What is the significance of DKMA's feedback for Bio-Convert's QR-02 drug candidate (NORD)?
How does Bio-Convert's QR-02 formulation differ from conventional oral treatments?
When will Bio-Convert (NORD) begin First in Human trials for QR-02?
What is the target condition and expected outcome for Bio-Convert's QR-02 treatment?
