Bio-Convert Receives Positive Feedback from The Danish Medicine Agency (DKMA) on its Lead Drug Candidate, QR-02 for Oral Leukoplakia
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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?
