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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ViR (We are developing ground-breaking therapeutics to cure currently untreatable respiratory infections affecting children and the elderly)

Teaser

Summary

Respiratory infections cause greater morbidity and mortality than all cancer types together. One of the most common causes for human respiratory conditions is the respiratory syncytial virus (RSV), with over 33 million new cases occurring annually worldwide. RSV infects 90% of children within the first 2 years of life, accounting for 45% of the total children hospitalization admissions. The virus is an important source of infection and mortality in the elderly population and in transplant recipient patients. RSV infections also lead to increased likelihood of bacterial co-infections and thus to increased use of antibiotics.
In addition to its significant impact on human health, RSV infections cause a tremendous burden to the healthcare system, with hospitalization-related costs of more than twelve billion dollars per year worldwide. Despite the significant burden on society, currently there are no effective therapies to cure RSV infections, underscoring the limitations of the traditional pharmaceutical approaches and the urgent need for innovative therapeutic solutions.
In ViRelieve, via scientific research, we have discovered weaknesses in the biological processes that are essential for the establishment and development of the RSV infection in human. We have developed innovative approaches to block these processes and thus stop RSV from causing disease and we have used these approaches to develop early-stage therapeutics. Our research has shown that our innovative therapeutics can efficiently block the RSV disease in animal models. Our overall objectives are to further develop our therapeutics to the point where they can be tested in large-scale studies. After completion of these studies, ur primary objective will be to make these therapeutics available to the general population and bring them to the clinic, where treatments are urgently needed.

Work performed

During the initial funding period, we have completed several key tasks.
1) We have negotiated and obtained two exclusive licenses from Foundation the Ark (Switzerland). These licenses cover patents issued for innovative therapeutic approaches to cure RSV infections (Patent numbers WO2015/135925 and WO2017/149098). These exclusive licenses guarantee IP rights for the innovative technology and will allow us to secure future funding.
2) We have established key collaborations with University of Applied Sciences and Arts (Switzerland) and the Foundation The Ark. Via collaboration contracts, we secured incubations space (office and wet lab) from both establishments. Further, Foundation the Ark will also provide business and administrative support in the early stage of ViRelieveâ€™s development.
3) We advanced our market assessment studies via landscape analysis. We identified that there is a clear needed for ViRelieveâ€™s products, and a well-defied multi-billion market gap in the antiviral therapeutics market.
4) We have gathered information, via secondary and primary research, and composed a more complete business plan that will allow us to approach investors. This information also allowed us to identify additional axes for secondary and primary research and market assessment.

Final results

Respiratory Syncytial virus (RSV) causes debilitating infections worldwide with a significant economic and societal impact. During the feasibility study we expanded our market analysis, which clearly showed that despite the significant burden on society and economics, currently there are neither effective therapies to cure, nor effective vaccines to prevent RSV infections. Further, primary and secondary research indicated a clear need for therapeutic solutions to treat RSV infections in the clinic. Building on our initial market assessment, during the feasibility study we quantified the pharmaceutical antiviral therapeutic market as a multi-billion market with a clear gap due to the lack of marketed RSV therapeutics. These findings indicate that there is a clear need for our therapeutic products in the clinic and that our products will enter a clearly defined and high-volume market and fill an existing gap, suggesting that our project is economically sound.
During the feasibility study we also performed a more in-depth competitive landscape analysis, which allowed us to discover that several of our main potential competitors have interrupted their programs due to failure in clinical trials, mainly due to a lack of effectiveness of their therapeutic candidates. The competitive landscape analysis also allowed us to identify strengths and weaknesses in the current and potential future competitors, and most importantly, reinforced our findings from our market analysis, that there is a clear and unmet need for RSV therapeutics.
The more advanced technical analysis that we conducted during the feasibility study provided strong evidence that targeting essential virus protein-protein interactions is an excellent approach for developing therapeutics to treat RSV infections. Our analysis indicated that using short peptides as inhibitors of these protein-protein interactions represents a viable strategy and an alternative to the traditional pharmaceutical approach of using small molecule inhibitors. We confirmed that the innovative peptide stapling approach allows to develop peptide therapeutic candidates with superior pharmaceutical properties.
During the technical feasibility study, we also reviewed in more details the current stage of technology and identified the key milestones to achieve commercialization. For each key milestone, we outlined the main activities and developed a plan for implementing a given activity within ViRelieve or identified and contacted a partner specialized in a given activity. We estimated the costs of our project, which indicated a favorable return of investment, providing additional evidence that our project is economically sound.
Upon completion of the project and clinical trials, ViRelieve expects to have therapeutic products to treat RSV infections in the clinic. The more in-depth market, competition and technical analyses that we did during the feasibility study uncovered higher than initially estimated potential economical and societal impact of ViRelieveâ€™s innovation: our product holds the potential to significantly decrease RSV-associated death burden and save thousands of lives in the pediatric, transplant and elderly populations. Further, our product is expected to significantly reduce the current RSV-associated hospitalization costs, relieving multi-billion dollar economic burden.