Drug development against antimicrobial resistance

In the battle against infectious diseases, antimicrobial resistance is in the spotlight: it has become a growing and worrying challenge. Therefore, at HIFAS Biologics we have a strong commitment to tackle this problem by developing new fungal-derived antibiotics. But how much time and effort does it take to take a new drug from the initial idea to the clinical phase?

Discovery of new chemical entities (2-5 years)

The first phase of drug development is the early discovery of the species. This is where the magic of nature comes into play. During this period a wide variety of fungi would be explored, looking for those with promising properties to fight infections resistant to traditional antibiotics. This process is no easy task. It involves cultivating fungal strains under controlled conditions, assessing their potential usefulness and extracting the bioactive fractions of interest. Each fungus is unique, and studying it requires a meticulous approach to identify molecules that could become the next revolutionary antibiotics.

Preclinical development (2 years)

Once molecules with potential in the development of new antimicrobial drugs have been obtained, the next step is preclinical development. During this phase, detailed studies are conducted to assess the safety, efficacy and toxicity of the extracted bioactive compounds. These studies are essential to ensure that the new medicine is safe for use in humans. Tests are conducted in cell and animal models to understand how the compounds interact with microorganisms and how they affect the human body. In addition, chemical analyses are performed to characterise and optimise the compounds, preparing them for the next stage of the development process.

Clinical development (5-10 years)

Final and longest stage of drug development is clinical development. Here, bioactive compounds that have passed preclinical testing undergo clinical trials in humans. This phase is divided into several stages:

Phase I: The safety of the drug is evaluated in a small group of volunteers.

Phase II: The efficacy and effectiveness of the drug is studied in a larger group of patients.

Phase III: Larger trials are conducted to confirm efficacy, monitor side effects and compare the new drug with existing treatments.

Phase IV: Following approval, the safety and effectiveness of the drug in clinical practice is monitored.

During these stages, scientists work closely with doctors, patients and regulators to ensure that the new medicine meets the highest standards of quality. However, through our meticulous approach and cutting-edge technologies, we at HIFAS Biologics hope to deliver effective solutions to combat antimicrobial resistance and improve global health.