Home Interviews Abliva signs global license deal for NeuroSTAT

Abliva signs global license deal for NeuroSTAT

Ablivas vd Elle K. Donnelly på Medicon Village, Lund

Abliva signs global license deal for NeuroSTAT

16 November, 2023

On Tuesday evening, Abliva announced a licensing and collaboration deal with US-based Owl Therapeutics for the development of NeuroSTAT for Traumatic Brain Injury. The deal includes potential milestone payments of 43,65 MUSD. BioStock reached out to Abliva’s CEO Ellen K. Donnelly for a comment.

Biotech Abliva is known for developing much-needed treatments for Primary Mitochondrial Disease (PMD or ‘mito disease’). Lead candidate KL1333 is currently undergoing a potentially registrational phase II-study and Abliva recently announced that the target number of patients for screening in the first wave had been reached. Read more.

NeuroSTAT against TBI

But Abliva has other assets targeting mitochondria, and one of these – NeuroSTAT, a treatment for traumatic brain injury (TBI) – is now proving its worth through a licensing deal. NeuroSTAT has a long history at Abliva and was a key program in the portfolio before the company shifted focus in 2019 to developing therapies to treat patients with Primary Mitochondrial Disease. TBI is caused by external violence to the head and can lead to functional impairments that require lifelong care. This means a heavy burden for both patient and the healthcare system, burdens that NeuroSTAT is aimed to ease by counteracting the neurological and functional injuries caused by TBI.

NeuroSTAT has received orphan drug designation in both the US and Europe. In addition, the drug has both Fast Track status and IND approval to start clinical studies in the US. Since then, the company has been open about the desire to find a strong, US-based partner to take the program further in development.

Global licensing and collaboration deal for NeuroSTAT

Although Abliva is now clearly focused on the development of therapeutics for mitochondrial disease, Tuesday’s announcement makes it clear that Abliva has not been idle when it comes to NeuroSTAT. The company’s work has now born fruit in the form of a global licensing and collaboration deal with US-based Owl Therapeutics, a wholly owned subsidiary of Gryphon Bio, and biopharma company focused on developing diagnostic-powered therapeutics for TBI. The deal means that Owl Therapeutics secures the global license, excluding China and South Korea, to develop and commercialise NeuroSTAT.

Looking at the financial side, Abliva is eligible to receive up to 43.64 MUSD in milestones. This sum excludes royalties. Of this 1.15 MUSD will be paid when specific clinical and regulatory milestones are reached as well as up to 42,5 MUSD when certain commercial milestones are achieved. In terms of royalties, Abliva are eligible for mid-single digits upon commercialisation, based on net sales.

Whilst Owl Therapeutics will be responsible for all costs associated with the development, manufacture, and commercialisation, Abliva will still play an important role. The deal is collaborative and the Abliva team will be involved in the development of the NeuroSTAT project going forward.

CEO comments

The stock market had waited for news on the project for several years and voiced their approval with an increase in the share by 24,31 per cent on Wednesday.

BioStock contacted Abliva’s CEO Ellen K. Donnelly to talk about the new agreement and what it means for Abliva.

Ellen, congratulations on the deal! Can you tell us a bit about how the collaboration with Owl Therapeutics came about?

Ellen Donnelly, CEO, Abliva
Ellen Donnelly, CEO at Abliva

– Since 2017, Abliva’s strategy has been focused on the development of medicines for the treatment of Primary Mitochondrial Disease (commonly called ‘mito disease’) with the portfolio focused on KL1333 and NV354.  Although the NeuroSTAT program is very compelling, the business models for TBI and mito disease are quite different and thus it was difficult to progress both in parallel. For this reason, we’ve communicated that we were looking for a strong, US-based partner to develop the program and optimise the value of this important asset.

– We are delighted to now have found an experienced team to take this program through development to TBI patients. We have been impressed with the Owl teams’ expertise and focus in TBI and are confident that this team will be able to optimise the development of NeuroSTAT. We became aware of the team and their efforts through Todd Kilbaugh, Associate Anesthesiologist in Chief at the Children’s Hospital of Philadelphia, Professor of Anesthesiology, Critical Care Medicine, and Pediatrics at the University of Pennsylvania and Advisor at Owl, who ran many of the early experiments performed with NeuroSTAT. We are excited that NeuroSTAT will now be prioritised, and we look forward to working with Owl as they continue to build on the already solid foundation of the NeuroSTAT program.

Can you elaborate on the specific clinical and regulatory milestones mentioned in the agreement, and what key developments are expected in the near term that could trigger the initial 1.15 MUSD payment to Abliva?

– The milestone payments will cover the key milestones that exist on the path to market approval and commercialisation. We feel that NeuroSTAT is well positioned to successfully achieve these milestones due to a number of factors including the favorable properties demonstrated by NeuroSTAT in the Phase Ib/IIa clinical study, orphan drug designation (US, EU), IND approval (US), and Fast Track designation (US). The unmet medical need in TBI is substantial, and we are confident that the team at Owl has the experience and focus required to take this program to the market.

The Abliva team will still be involved in the development of NeuroSTAT. What will the involvement look like?

– We will remain involved in the program through a Joint Steering Committee (JSC) which will ensure alignment and communication across the team. In addition, the Abliva team will partner with Owl to ensure  the successful transition of the program.  Going forward, Owl will have all decision-making rights for the asset and will pay for all costs associated with the program.

What are the next steps to get the collaboration going?

– Owl Therapeutics will continue to progress the development activities already initiated by Abliva, including preparations for the phase II clinical trial which has been approved by FDA. The team at Owl has extensive experience working with various funding sources in the US to progress therapies of high unmet need, including the Department of Defense (DOD), and will likely expand the opportunities Abliva has started to progress the program through late clinical development towards marketing approval. Abliva will remain involved in the program in a collaborative basis to ensure the transition is successful and the asset is well positioned for success.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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