The decision to change the name was taken at the Annual General Meeting on 20 May 2020. The change of name to Abliva AB follows the new company strategy focusing on primary mitochondrial disease.
The focus going forward will firstly be on the KL1333 program where the company, in the ongoing Phase Ia/b clinical study, will initiate the patient part when the covid-19 pandemic allows start considering patient safety. In parallel, the KL1333 clinical trial material and the Phase II clinical study is being prepared to start in accordance with plans the first half of 2021.
In the second project in focus, NV354, preclinical safety studies are ongoing and drug substance has been produced with the aim to take the project into clinical Phase I next year.
“There is a great unmet need of treatment alternatives for primary mitochondrial diseases, which lead to severe suffering for patients and their families. Our increased strategic focus, together with a strengthened financial position after the recent rights issue, gives us good opportunities to deliver much needed new treatment alternatives to patients who need them and at the same time build shareholder value”, said Erik Kinnman, CEO.
In line with Abliva’s core focus on its primary mitochondrial disease projects, a process, subject to funding, has been initiated to transfer the US and European rights to develop and commercialize the NeuroSTAT program in traumatic brain injury into a wholly-owned US company. The purpose of which is to increase the possibilities to continue building value in the Phase II ready NeuroSTAT clinical program. The US FDA has approved the NeuroSTAT IND application, it has previously received orphan drug designation in the US and EU, and FDA recently gave the program a Fast Track designation. Rights to develop and commercialize NeuroSTAT in Asia rest in the company’s Hong Kong-based subsidiary.