Aerosolized Medicines against Viruses

Infectious viruses that enter the airways and stationed in lungs, such as SARS-CoV-2, poses a deadly threat to human species. There are no known drugs that are effective against such viruses and the current 're-purposed' drugs are administered by systemic means that do not concentrate the drugs in pulmonary system. To prevent viral replication at the lungs, we are proposing to deliver a cocktail of silencers (siRNAs) against the viral genome to lungs using inhalational delivery. This innovative solution is based on 3 premises: First, siRNA can be designed against any target at will. Second, siRNAs can be make effective in human tissues by delivering them with synthetic materials. Third, siRNAs can be ‘aerosolized’ for inhalational delivery to lungs. Our solution will enable survival of patient caught in the current pandemic as well as the new waves expected in coming months and years.

Our idea will be applied to the immediate solution of the Coronavirus Disease 2019 (COVID-19). COVID-19 is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It originated from the SARS-CoV that spread in 2002-4 and led to ~900 deaths. The current pandemic is much larger (~320,000 death as of May 18, 2020) whose magnitude is bound to increase in time. Whether it is a coronavirus or any other virus causing the pandemic, effective anti-viral drugs do not currently exist. Even if the current drugs are re-purposed to display some effectiveness against the current pandemic, it is extremely difficult to predict what new virus will emerge and which type of drugs will be effective against the new viral strains. Developing a conventional drug against a new strain of virus will be time-consuming and will not yield results in the order of weeks/months necessary to confront an epidemic. We will develop a new type of drug directly from the genetic make-up of the virus. Our drugs can be generated within a matter of days directly from viral genome sequence. Such a fast response will ready the medicine before the problem reaches to pandemic scale.

This innovative solution is based on three premises:

First, the silencer siRNA can be designed against any viruses at will. As long as genetic sequence of a virus is known, one can design an effective siRNA silencers to shut down the replication of virus. Unlike drugs, we can include a cocktail of siRNAs against a critical target or a combination of targets so that desired targets can be shut-down very efficiently. This will lead to most potent anti-viral agents with little chance of the virus to develop resistance to the agents. 

Second, siRNAs can be make effective in humans by delivering them with synthetic materials. We will use harmless polymeric materials to deliver siRNA into lung cells. We have already tailored such materials, and showed that non-viral delivery of siRNA is effective in lung cells as and preclinical animal models.

Third, siRNAs can be ‘aerosolized’ for inhalational delivery to lungs. Because the foremost urgency is to stop viral replication at lungs, inhalational delivery is ideal to allow direct deposition of our medicines at the site of the most urgent need. Inhalational delivery of liquid suspensions (as nasal sprays) and active pharmaceutical ingredients (API) are now routinely marketed.  

Our solution will serve the COVID-19 patients immediately. The patients that will most benefit will be the population hospitalized in the intensive care units due to severe disease and inability to sustain life on his/her own. It is the excessive viral load at the airways/lungs, the associated damage caused by the viruses in lungs and the immune system, which reacts to the presence of virus and produces damaging agents to the lung tissue. We want to deliver our medicines to the lungs of these patients so that the silencer agents will shut down the production of the virus and prevent replication. This will directly lower the viral burden in this critical organ and dampen the damaging effects of the immune system in the respiratory system. The patients body and respiratory system will be allowed to return to normal functioning due to reduced viral burden. To translate our solution to the patient use in the shortest possible times, we are recruiting clinical centres that can adopt our medicines to inhalational delivery and minimize any development time for clinical entry.

Our idea will prevent loss of lives from unpredictable pandemics. We are proposing a therapeutic solution to viral pandemics that will ultimately save lives. Our solution will generate medicines in a fraction of time (weeks) that usually takes for conventional drugs (years) and will be ready to deploy exceptionally fast. Our drugs will rely on genomic sequence of viruses causing pandemics, and the resultant drugs (short interfering RNAs) will be ready as soon as viral genome is sequenced. Our idea is not only applicable against the current pandemic but also against new pandemics bound to emerge in the future.

At the core of our technology