Novel pan antiviral drug- In vivo efficacy to stop SARSCoV2 pandemic

We developed a new drug platform which makes cells resistant to many pathogenic viruses, including covid19. Our drug candidate modifies RNA processing, a feature essential to viral,  not human cell, proliferation. Viruses cannot proliferate and therefore, are unlikely to mutate to become resistant to this highly orally bioavailable nontoxic drug.

 Dr Clifford Lingwood biochemist-team leader, CSO ViroCarb - technology licensee.

Dr Alan Cochrane- Medical Genetics, University of Toronto -primary investigator.  

Dr Mario Huesca- President ViroCarb,

 Dr Bharat Tewarie- CEO ViroCarb. 

The covid19 pandemic has had devastating effects worldwide.  This infection is without precedent since the 1918 influenza pandemic. Ease of travel,high population density, combined with inappropriate animal markets, has allowed covid19 infection to spread across species and across the world. While vaccines offer the end game opportunity to control this infection, a mechanism for immediate relief of infected individuals/alleviation of symptoms and prevention of transmission to contacts remains, and will remain, an urgent requirement. Moreover, immune dysregulation is characteristic of covid19 infection, such that vaccination of the infected could be problematic and acute therapeutics will remain urgently required for infected/symptomatic individuals. In addition, it remains unclear whether immunoprotection against covid19 will protect against possible future corona virus “pandemics”. Mutations in the covid19 spike protein such as reported in  UK, South Africa, Brazil could engender resistance to vaccines which currently all target this immunogen. The occurence of such mutations further emphasize the global need for effective immediate anticovid19 drug therapies. The thousands of coronaviruses strains (see fig) indicate instability. Even the variants (coloured) are variable.

In addition, future potentially pandemic viral infections e.g. further bat corona viruses crossing species, will be sensitive to our treatment but not to current vaccines.

Our target 'audience' is the general public. We will target governmental/private healthcare providers to facilitate dispensation of our (FDA approved) drug to prevent/treat acute covid19 infections worldwide. The covid19 pandemic has affected most, and devastated many countries worldwide. Millions have been infected and millions died. The lack of effective targeted treatment allowed the unprecedented transmission of this infection. Our drug will be given to symptomatic/asymptomatic covid19 positive patients and their contacts. High risk groups have been identified. We envision a two week oral treatment to stop/prevent infection. This will stop transmission, prevent symptoms (including long-term) and fatalities. Our treatment infact, makes individuals virus resistant. The virus cannot replicate/mutate and drug resistance is less likely.

 Vaccination will provide long term protection but in the short term, an effective treatment option is required, one that can be stockpiled and given immediately following outbreaks. Future potential viral pandemic outbreaks (and even variants of the current covid19) may not be protected by current vaccines, so an immediate treatment is vital. Our drug works against multiple viruses and will be effective against new viral infections.

We are imminently contacting the FDA and Health Canada in order to facilitate fast track IND studies and clinical trial.

Our pan antiviral therapy will provide a therapy for many of the world's  currently untreatable pathogenic viral infections. Our treatment offers the means to treat the covid19 pandemic and potentially, to contain any future viral 'pandemic'.

The covid9 pandemic is the worst scourge of this generation and no effective therapeutic has yet been found. While vaccines will provide protection, it is questionable whether covid19 or the variants that are arising, will be fully controlled. Our approach will provide an additional  reliable, cheap, oral medication to stop and prevent acute infection worldwide. Because we target (virus essential) host cell metabolism, development of viral drug resistance is unlikely.

 At the onset of any future potential viral pandemic (now widely expected), vaccines will not be available, but if GPS491 is sufficiently stockpiled, its rapid administration should result in the prevention of widespread transmission and the danger of such infections.

Our solution does target vunerable populations: those infected by untreatable viruses. While elderly and immuno-compromized individuals may have higher risk, viral susceptibility is found for all ages.  The covid19 variants are recently showing mortality in ever younger individuals. By controlling viral infection, we will reduce suffering and the burden on medical systems.  This in turn, will  greatly reduce the economic impact of such infections. In terms of covid19, we will prevent respiratory failure, death and long-term symptoms associated with this disease.

Our initial approach will be to treat acute viral infections where we can achieve an effective therapy. Our treatment would allow time for an immune response to eliminate the virus.  This would apply to covid19 and any similar acute infection.  However, for pandemic infections such as HIV, where current control is only achieved by life-long drug treatment, further investigation with regard for (very) long-term safety and efficacy against latent viral reservoirs  will be needed.

Within two years, we plan to have initiated phase I/II clinical trials. We will apply for fast track FDA approval.

Within less than 3 years, following successful clinical trial, we plan to have our approved drug available to patients worldwide. This will have a transformational effect on millions, perhaps billions of lives. Beyond pandemic infections, GPS491 will effect a therapy for untreatable viral infections of previous, everyday concern, such as herpes cold sores, herpes vaginal infections even perhaps the common cold (Rhinovirus requires mRNA processing machinery).

 The more recent life threatening global infections, Dengue, Zika, Ebola,West Nile have all been reported to be sensitive to cardiac steroids, which  we have shown also alter host cell mRNA processing, and are therefore likely to be blocked by GPS491.

If ViroCarb's approach proves as effective as our in vitro indications, with FDA and other agency approvals and widespread drug distribution, we would expect the rate of global viral infections to be reduced. We will develop   epidemiological monitoring system in every instance of viral infection where our drug approach is adopted. Other organizations, such as WHO, and governmental agencies will also monitor the effect. Clinical trials will access the efficacy of our treatment.  Only if these trials are successful, will FDA approval be given, and only then can the clinical management of hitherto untreatable viral infections begin. The impact will then depend on scale-up, market access, supply, distribution and international buy-in.

We require funding to carry out the animal model infection studies. If our lead drug candidate has some surprising toxicity issue, we would transit to one of our several back-up small molecule species. This risk is minimized, since covid19 is highly sensitive to our drug candidate. High dose levels of GPS491 will not be necessary to achieve systemic covid19 blockade. Several other small molecule splicing inhibitors in clinical trial (at higher doses than proposed for GPS491) for other diseases have not reported significant adverse effects.

University of Toronto

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In order to attract investment for IND studies and clinical trials, we need to perform in vivo efficacy studies against SARCoV2 in an animal model. The Syrian hamster model is the most appropriate and this is available at the level 3 containment facility at the University of Toronto. However in order to carry out such a study, we first need to perform extended pharmokinetic work to show that repeated dosing with GPS491 is without toxicity, and the minimum dose needed to ensure a sustained drug plasma level several fold above the concentration which is effective to block SARCoV2 propagation in cell culture.

 At this early stage of ViroCarb development, without in vivo efficacy studies, investor support would come with a high price tag. We prefer support which does not excessively impinge on the future direction of the company.

 We need funds to support a post-doctoral fellow's salary in Dr Cochrane's laboratory, for lab supplies, animals,and level 3 animal facility costs. We are applying to the Trinity Challenge to supply these unencumbered funds.

Gates Foundation. our contacts with the Gates Foundation have been unrewarding. We hope the Trinity Foundation can enable Gates support to promote the worldwide dissemination of our pan anti viral approach.

 WHO We would want work with the WHO to identify the regions in the world where our treatment can do the most good.

Covax This WHO program to facilitate vaccine access in underdeveloped countries could provide the most effective means to deliver our treatment to infection high risk countries.

Pharmaceutical companies. We will need to partner with an international pharmaceutical company in order to carry out covid19 clinical trials with GPS491. The funds required to carry out such trials is beyond the current scope of ViroCarb. We need the contacts to advance discussion for such studies. Our alternative option will be to submit an IPO to raise the necessary capital from investors directly as a public company.