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Nordic Nanovector announces key development decisions

Nordic Nanovector

Nordic Nanovector announces a number of initiatives to speed up recruitment of its clinical trial as well as extend its cash runway into 2021, including a reduction in staffing.

At the time of the Q4 results in February, the company noted that it would, under its new management, critically assess the current strategy and clinical trial operations. Following this assessment several key development decisions have been made.

“The actions that we have announced are designed to significantly improve patient recruitment into our Phase 2b PARADIGME trial with Betalutin and to extend our cash runway into 2021. We are confident that the changes we are making will enable us to deliver the key clinical data needed to support a planned US filing with Betalutin in a timely manner. I look forward to keeping you updated on our progress,” says Lars Nieba, Interim CEO of Nordic Nanovector.

Intends to broaden PARADIGME’s inclusion criteria

The company will with all resources focus on its PARADIGME clinical trial and all other clinical trials to be suspended following completion of the current cohorts. In addition, all investments in pre-clinical assets are to be halted. The company also plans to amend the current PARADIGME protocol and intends to broaden PARADIGME’s inclusion criteria to increase rate of recruitment.

“We have recently seen a slowdown in recruitment into the PARADIGME study due to measures taken by many governments in respons to contain the COVID-19 pandemic, as well as the need for hospitals to prioritize resources on treating infected patient,” explains the company.

A reduction in staffing levels by approximately 20%

In parallel, several cost savings initiatives are being implemented to extend the company’s cash runway into 2021. For example, a reduction in staffing levels by approximately 20% is to be completed by end April and consolidating several staff functions and closing offices.

Resources will be focused on core clinical operations and CMC (Chemistry, Manufacturing and Controls) and phased investment in CMC and pre-commercialisation activities with some spending will be moved into 2021

“The company will provide a further update on PARADIGME when it has received and reviewed the feedback from its discussions with the FDA. Nordic Nanovector still plans a rolling submission for Betalutin with FDA once it has the top line data from the PARADIGME trial,” it states