In October, NeuroVive introduced a new strategy for the company – instead of spreading its resources across four indication areas, they chose to focus their work on primary mitochondrial diseases. Of the company’s other three projects, NeuroSTAT against traumatic brain injury (TBI) is the most advanced, and NeuroVive now plans to transfer the rights to develop and commercialise NeuroSTAT to a new company in the United States. CEO Erik Kinnman told BioStock more about this move.
When Lund-based NeuroVive Pharmaceutical held its first Capital Markets Day last October, the purpose was to present a new strategy. Since the company was founded in 2000, it grew to have a broad focus spanning four areas of indication: primary mitochondrial disease, TBI, NASH (non-alcoholic fatty liver disease) and liver cancer.
As all projects have advanced steadily in recent years, NeuroVive decided that the best way to allocate resources in order to optimise results and create value for shareholders was to focus on the projects concerning primary mitochondrial diseases. For the three other areas, this meant reduced resources and that development in the future would primarily be conducted outside the company.
NeuroSTAT – a treatment against brain injuries
When NeuroVive was founded, its focus was on the development of treatments for traumatic brain injury (TBI), i.e., brain damage that is the result of external violence to the head. The work has resulted in the candidate NeuroSTAT, which focuses on protecting the mitochondria, the parts of the cells that are responsible for creating the energy we need in order to function. The goal of NeuroSTAT is to counteract that neurological and functional injuries occur after TBI. These injuries can lead to functional impairments that require lifelong care and are therefore a significant burden for both the patient and the healthcare system.
Orphan drug status and Fast Track
NeuroSTAT has made significant strides towards market launch and has shown positive results in a phase II clinical study that looked at safety, tolerability and pharmacokinetics. In addition, analyses of biomarkers for brain cell injury in samples from patients have indicated a possible positive effect. The candidate has now been prepared for a phase II efficacy study.
It is also worth noting that NeuroSTAT has been granted orphan drug status in both the US and Europe. In the US, the candidate also has IND approval to start clinical studies and Fast Track status.
New company in the US
In order to take the development of NeuroSTAT to the next level, and in line with NeuroVive’s focus on primary mitochondrial diseases, the company has now decided to license the rights to develop and commercialise NeuroSTAT to a new company in the US. One exception, however, is the rights on the Asian market, which will remain with NeuroVive Asia Ltd.
NeuroVive’s plan is to establish the new company in the US during the second half of 2020, provided that financing can be obtained.
BioStock contacted NeuroVive’s CEO Erik Kinnman to find out more about the new strategy for NeuroSTAT.
Erik Kinnman, can you tell us a bit more about the purpose of the new American company and its significance for the development of NeuroSTAT?
– In line with our strategy to focus on the projects in primary mitochondrial diseases, KL1333 and NV354, we also want to create favourable conditions for the continued development of NeuroSTAT. We have approval in the US to start the planned phase II efficacy study. Furthermore, there is a great interest in developing treatment options for brain injury among clinical experts, the public as well as at various institutions.
What does the timeline for the establishment of the new company look like?
– We are now starting a process where, with the help of advisors in the US, we will look at the best possible structure and financing for the company and clinical studies. Given that we organise financing, we expect to establish the new company during the second half of this year.
In the press release you mention that the establishment of the company in the US is subject to financing. What does the strategy for this look like and do you have any ideal partners / financiers in mind on order to ensure the continued development?
– In line with what we have communicated earlier, we are exploring opportunities to find suitable partners and non-dilutive funding of the phase II efficacy study. The goal is to find partners / financing from actors that have both a great interest in and knowledge of brain damage.
If we switch or focus to the candidate NeuroSTAT itself, how does NeuroSTAT differ from existing treatments for traumatic brain injuries?
– The great interest is due to the fact that there is currently no specific treatment for traumatic brain injury. In addition, there are few rival projects under development. The current treatment is symptomatic and is mainly aimed at reducing the pressure on the brain caused by bleeding and inflammation.
What does the market for NeuroSTAT look like given the limited treatment options available today?
– The need is clear and since no drug is available and we have orphan drug status for medium to severe traumatic brain injury, the potential for a high price and large market for NeuroSTAT is significant.
Finally, the aim of the new strategy is to free up resources for your primary activities. What is highest on your agenda now and what news can we hope for from NeuroVive during the remainder of 2020?
– Exactly, in the future we will be able to further focus on the projects in primary mitochondrial disease, where we look forward to starting and reporting results from the final part of the ongoing phase I a/b study with KL1333 this year, at the same time we are preparing KL1333 for a clinical phase II efficacy study that will start in the first half of next year, and we are preparing NV354 for the start of a first clinical phase I trial during the first half of next year.
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