Generally if a patient is infected with a viral disease, there are only two main treatment options: vaccines and direct antiviral medication. However, the Columbus-based startup Invirsa is developing a new treatment approach.
Currently in the preclinical stage, the drug being developed by Invirsa supports the body’s natural immune response to viral infections, while also stimulating the repair of damaged cells. The drug doesn’t directly kill the virus itself; rather, it boosts the body’s immune response using a compound derived from a molecule that is naturally found in all human cells. The molecule helps regulate the activity of systems critical to immune response.
“When you think about diseases — particularly viral infectious diseases — you get the infection, and then the infection causes damage,” said Isaiah Shalwitz, vice president of business development and operations for Invirsa. “The bacteria or virus that causes the infection goes away, but you’re still left with the damage and therefore the long-term recovery. Our drug would also help with the recovery phase.”
Shalwitz co-founded Invirsa with his father, Dr. Robert Shalwitz. With over 20 years of experience in drug development, Robert Shalwitz has helped lead new and supplemental drug approvals while working with Abbott Laboratories and Reliant Pharmaceuticals. He then co-founded Akebia Therapeutics and Aerpio Therapeutics. Isaiah worked as a biostatistician for Akebia and has worked in drug development for 10 years.
As far as the Invirsa startup is concerned, it began in part when Robert discovered the molecule of the same name (technically dubbed INV-102) during his time with Ross Laboratories (now part of Abbott). He found that it worked to treat oral mucositis, a complication of cancer treatment that causes damage to the mouth and pain in swallowing. However, his original plans for a startup based on this treatment didn’t quite work out.
Later, new research came out that convinced Robert the treatment could work for viruses. A Columbus ophthalmologist suggested using the treatment for adenovirus, the main virus responsible for causing conjunctivitis (pinkeye), as there is currently no available treatment for viral conjunctivitis. Shalwitz tried the treatment for this adenovirus and paid for the in vitro testing himself, which found that his treatment worked to inhibit viral replication.
“That’s what’s so exciting about Invirsa,” Isaiah said. “We have this drug that boosts the natural immunity. In theory, it could be used for a wide variety of diseases.”
The Columbus-based venture capitalist Rev1Ventures gave Invirsa pre-seed investment in order to develop the first efficacy data. Then, Invirsa raised their seed round in 2017 with Rev1, Cincinnati-based CincyTech, and two more small investors. The seed round helped Invirsa further develop their efficacy data. Now with this data, Invirsa is looking to raise Series A funding to take the drug into the clinical phase.
“We are opportunistic about what we will do with the company assuming our clinical studies are successful,” Isaiah Shalwitz said. “Personally, my father and I just want to see the drug succeed and to give it the best chance possible because we think it could be an amazing treatment for lots of people.”
He said Invirsa will consider either a buyout offer or further developing the drug and marketing it themselves. He and his father hope that the treatment will be widely applicable and eventually available all over the world, because it is cheap, stable and easy to use.
“The uniqueness of the drug is the most exciting thing. It’s a natural molecule, so we believe it will be very safe,” Isaiah Shalwitz said. “The innate immune response is a very unique approach, especially in the infectious disease area. "That’s what’s so exciting, and why we hope this molecule has such big potential in a lot of ways for a lot of diseases.”
While the drug currently being developed by Invirsa will only treat conjunctivitis, the company hopes to use the same approach to develop drugs for other viral infections, including respiratory viral infections such as influenza.
“Our growth is entirely determined by the data and the science that we develop,” Isaiah said. “We have lots of good data and we have lots of collaborators all around the nation in a variety of areas that are helping to test our drug.”
The next step for Invirsa is to raise the Series A round of funding, which will allow the company to file their application to take their drug into the clinical testing stage, or human trials. They expect to enter this stage nine to 12 months after completing this round of funding.
