Innovating Healthcare Safety with PyroDex with Dr. Djik Maouyo

An expert in pyrogenic assays, Dr. Djik Maouyo shares his passion for developing safe therapeutic products to accelerate their commercialization. In this Q&A, he discusses his ideas on reducing the economic burden from failed clinical trials. 

Why did you find PyroDex?  

I founded PyroDex to increase clinical trial success, ensure safer drugs, and save lives. For nearly 50 years, horseshoe crab lysates (LAL) have been used to detect endotoxins, but trial success rates remain low. We developed the Monocyte Activation Test (MAT), a highly sensitive method that detects fever-causing contaminants from raw materials to all clinical trial phases. Many trials fail due to undetected contaminants with current methods. Our approach can achieve up to 70% success in clinical trials and boost therapeutic product commercialization.  

How does PyroDex conduct testing?

Biomaterials must be tested for intrinsic pyrogenicity (fever-causing potential). Our MAT method accounts for the specific pyrogenicity profiles of contaminants, detecting both endotoxins and non-endotoxin pyrogens using human blood cells. Unlike the traditional LAL method, which only detects endotoxins, our method ensures safer drugs enter phase I clinical trials, potentially increasing success rates beyond the current 7-13%. Our method does not require prior knowledge of the contaminant’s molecular structure and recognizes pyrogenicity of ingredients and interactions between biomaterials, even when they are safe when tested separately. 

What is the MAT assay’s competitive edge, and what target markets are you aiming for?  

Both parenteral drugs and Class III medical devices need pyrogen testing to ensure safety. Our Monocyte Activation Test (MAT) is a quantitative method that accurately measures pyrogen levels in therapeutic products, including small molecules, biologics, and implantable devices. Unlike traditional tests, our agnostic biodetection system evaluates overall product safety, providing comprehensive insights for sound business decisions. This is our competitive edge. Our target markets include the parenteral drug industry, implantable medical device manufacturers, and suppliers of biomaterials and ingredients.  

What is the impact of PyroDex's technology on public health and the economic burden?  

We expect PyroDex’s technology to impact public health significantly. Currently, only 10% of drugs entering phase I clinical trials reach the market –leading to substantial losses. PyroDex’s MAT can reduce this economic burden by ensuring drug safety. This also helps mitigate public reluctance towards clinical trials and vaccinations, thereby promoting overall public health and welfare. 

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