A new treatment of serious infections caused by enterovirus and respiratory syncytical virus in children

Purpose and goal:

The purpose of the project was to prepare for the possibility of testing CUR-N399 clinically in children and to evaluate if the substance, which has been developed as an antiviral against enteroviruses, can also work against RSV and HMPV which are two virus classes that also affect children.

We have developed a new formulation that can be used in children. We have carried out toxicity studies that are required and we have also shown that the substance has an effect against RSV-A in both in-vitro, ex-vivo and in-vivo models. However, the effect against RSV-B and HMPV is much poorer. Expected results and effects:

We have been able to show that the toxicity profile in adult and young animals looks the same. We have been able to show effect of CUR-N399 against EV71 in juvenile mice. EV71 is a relevant virus as it primarily affects children.

We have also shown that the substance has an effect against RSV in several different in-vitro models and in an in-vivo model. However, the substance has a very weak effect against HMPV. We have also developed a buccal film that could be used for easy administration in children and where you can adjust the dose with regard to weight by dividing films into different sizes.

Approach and implementation:

We have, in collaboration with the University of Gotthenburg, tested the substance´s effect against the RSV virus. We have also, in collaboration with the University of Umeå, studied the substance´s effect against RSV in a 3D in-vitro model that will simulate in-vivo studies. We have also, in further collaborations, evaluated HPVM in-vitro and RSV in-vitro.

Toxicity studies in juvenile mice according to GLP. As well as developed a buccal film in preparation for clinical trials. The first clinical study in adult volunteers with the new formulation by CUR-N399 is planned for spring 2023.