MAQTOX is partnering with CardioGenix Pharmaceuticals to drive the global regulatory strategy and clinical development of their lead cardiovascular drug, CardioGenix-1. This project focuses on accelerating the drug through preclinical and clinical phases to ensure rapid entry into global markets. The drug is designed to target a novel mechanism in heart failure patients and has shown promising results in preclinical models.
Key components of the project include:
- Regulatory Strategy Development: Crafting a comprehensive regulatory submission plan, ensuring all required documentation is prepared for IND and CTD (Common Technical Document) submissions in the U.S. and European markets.
- Clinical Trial Design: Designing Phase I and Phase II clinical trials to evaluate CardioGenix-1's safety, efficacy, and pharmacodynamics in human subjects.
- Stakeholder Engagement: Collaborating with regulatory agencies, including the FDA and EMA, to ensure the product’s progress through approval processes.
- Market Access & Commercialization Support: Providing guidance on commercialization strategies and market entry for global rollout.
This project aims to bring CardioGenix-1 to market as a novel treatment for heart failure, addressing a major unmet medical need and significantly improving patient outcomes globally.
