Exploration of Anti-infective Drug Development: Challenges and Emerging Opportunities

by | May 23, 2019 |

Anti-infectives are the agents or drugs that help to eradicate the infection from the human body. Some of the anti-infectives do this by inhibiting the action of the infectious agent (bacteria, viruses, fungi, etc.) and some by killing the infectious agent itself. As the infectious diseases like dengue fever, Ebola infection, tuberculosis, bacterial meningitis, malaria, etc., are rising at a high pace, the development of new anti-infective agents has become a global health priority.

However, the primary challenge that cannot be ignored is that the anti-infective agents are considered less profitable than other drugs. This is because the infectious agents become resistant to the treatment very soon, making it ineffective and leads to their short-term use. Thus, doctors avoid prescribing newly developed drugs and keep them reserved until older drugs fail. This creates another challenge, i.e., the pharmaceutical companies shift their focus of research and development to other drug types leaving the anti-infective agents. To bring the new anti-infective agents to the market, Food and Drug Administration (FDA), National Institutes of Health (NIH), and Centers for Disease Control and Prevention (CDC) should develop strategies so that the pharmaceutical companies who have potential research and development infrastructure can develop these anti-infective agents.

Besides this, another major obstacle faced to develop anti-infective agent is the expectation of the agent to be broad-spectrum, ie, a single anti-infective agent must inhibit the growth of several species of an infectious agent, along with its ability to penetrate up to required tissues (especially in case of eye infections). But the anatomical barriers such as skin, mucous membranes, etc. limit the availability of the anti-infective agent.

Besides this, it is estimated that the anti-infective agents are highly prescribed to pregnant women. But, as per the tight enrolment criteria in clinical studies, the pregnant population is mostly avoided for the enrolment due to the ethical concerns and health risks of the drug on pregnancy outcome and developing a fetus.

Even after knowing all these hurdles, a few large pharmaceutical companies have many anti-infective agents in its pipeline, which are at the late-developmental stage for infectious diseases such as influenza, HIV, bacterial infections, hepatitis, etc. Pharmaceutical companies can use existing and resistant antibiotics and can develop these in new ways to potentially create drugs that infectious agents will not become resistant to or drugs with better effects and safety levels. Therefore, a few companies are now focusing on the development of anti-infective agents based on a novel mode of action to make resistance-free products. Applying strong screening techniques to find these potential anti-infective agents can help produce the new classes of antibiotics. Both natural and synthetic anti-infective agents can be produced in this way. One such example is a hybrid macrolide which is a semi-synthetic compound with multiple activities. The development of this kind of compound, as an anti-infective agent, is a major opportunity for the research and development firms. Besides all these opportunities, a consortium known as COMBACTE helps to produce anti-infective agents by collaborating with pharmaceutical companies and creating a network of laboratories to develop and test the anti-infective agents.

Not only applying these strategies but also an effort from regulatory authorities is required to improve the scenarios for the development of new anti-infective agents and to accelerate their approval process.

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