Virologists see US FDA guidance on monkey pox to speed up drug development for viral infection

Bengaluru, February 14, 2023 :

Virologists have noted that the US FDA guidance on monkeypox will speed up drug development for the viral infection. The guidance provides nonclinical, virology, and clinical considerations for mpox drug development programes, with a focus on recommendations to support initiation of clinical trials.

Monkeypox is an infectious viral disease which manifests both in humans and animals. While this infection is commonly reported in the developing countries like Africa, India has its first case on July 14, 1922 in Kerala. India was the tenth country to report a monkeypox case in Asia and the first in South Asia. Currently, India has reported 23 cases of monkeypox. Currently, there is no drug available to treat and patients are treated based on symptoms with anti virals and anypyretics, stated officials from the Epidemic Disease Hospital in Bengaluru. 

In the absence of a common affordable drug and the dire need for a vaccine, let the global regulatory authority to come out with a guidance to give pharma companies a direction in drug development and clinical trials. Monkeypox virus is in the Orthopoxvirus genus of the Poxviridae family and is biologically similar to variola virus, the causative agent of smallpox).

The latest outbreak of monkeypox are expected to propel the research efforts. Currently the most commonly used drugs for antiviral treatment of monkeypox are tecovirimat developed by the US based SIGA Technologies, cidofovir developed by Gilead Sciences and brincidofov is by Chimerix .

Although FDA has approved drugs for the treatment of smallpox under regulations commonly referred to as the Animal Rule, this pathway is not applicable to drugs for mpox because researchers can design and implement clinical trials for mpox that are both ethical and feasible, said the guidance.

Additional nonclinical safety studies to support clinical trial initiation may be needed on a case-by-case basis. With regards to the virology considerations, the global regulatory authority stated that sponsors developing drugs for mpox should support clinical trial initiation for small molecule drugs or biological products. Sponsors should provide nonclinical virology information. The hypothesized or determined mechanism of action of the drug, including a description of the target protein and information supporting the mechanism of action, such as binding data with quantitative measurement of antibody, enzymatic inhibition data, resistance characteristics, and structural analyses need to be provided. 

There is also need for cell culture antiviral activity data against the current monkey pox virus outbreak strain/lineage. Data addressing the impact of serum proteins on antiviral activity in cell culture also need to be assessed and submitted, said the global regulatory authority.

Additional nonclinical virology studies that sponsors should conduct either before clinical trials or during clinical development to support NDA, or BLA submissions for small molecule drugs or biological products include assessments of antiviral activity against geographically and temporally distinct monkeypox virus isolates. Besides close observation of Mitochondrial toxicity and bone marrow precursor cell toxicity assessments for small molecule inhibitors potentially associated with this risk needs to be looked into, said the global regulatory authority. Pharmabiz