NeuroVive’s objective is to improve the health of people living with a primary mitochondrial disease (‘PMD’). At the same time, we want to safeguard the health of our clinical trial participants, cooperative partners, suppliers and employees in this difficult situation. We are implementing the measures recommended by international and national authorities and are holding regular talks throughout our organization and with our partners. Regarding our clinical trial operations, we also understand that health authorities and care providers could reassign available resources, beds and personnel in the healthcare sector to be better able to handle a potential surge of COVID-19 patients.
Currently, NeuroVive’s work is proceeding on the planned final stage of the Phase I a/b study with KL1333 against PMD. The trial centers in Newcastle and London, where the study is to be conducted, have informed us that, due to the situation with the COVID-19 pandemic, there is a risk of delays in recruitment to all clinical studies for some time to come. This will probably lead to the time for inclusion of the first patient in the concluding part of the Phase I a/b study with KL1333 to be delayed.
NeuroVive is working to adapt the study program for KL1333 taking into account the risk of delays, by modifying the structure of the upcoming phase II study, which is still expected to start during the first half of 2021. NeuroVive can thereby minimize the risk of delays in the overall study program for KL1333 without compromising patient safety or the data quality of the study.
NeuroVive’s preparations in the form of preclinical safety studies to be able to take the drug candidate NV354 for Leigh syndrome into the clinical phase in 2021 are not currently affected by the COVID-19 pandemic. The company has continuous contact with all parties involved and is monitoring the situation closely.
The Company’s planned participation in scientific, investor and partnering meetings will be replaced as far as possible by digital meetings.
“In these testing times, we are thinking of all the people who are directly or indirectly affected by COVID-19. The long-term consequences for individuals and families, as well as society at large, are difficult to forecast. These are extraordinary pressures that will impact the healthcare sector in many countries. At NeuroVive, we are developing drugs for severely ill patients and we will, with a continued high level of energy, in the best and fastest way possible continue development in order to secure the value for patients. We will keep our shareholders updated on developments and announce any news on delays as they arise,” says NeuroVive’s CEO Erik Kinnman.