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Beyond the Pitch

Invirsa Develops Natural Compound to Treat Pinkeye

Bob Shalwitz’s idea for his startup pharmaceutical company, Invirsa, is based on a naturally occurring compound that he’s been working on for almost 18 years.

“It’s an area of research that I was excited about early on for an entirely different disease,” said Shalwitz, M.D. and founder of Invirsa. “I kept thinking that we had a great opportunity to expand the potential indications for the compound.”

In particular, Shalwitz believed the compound might be useful in fighting viral disease.

“I’m a science geek, but we did not expect to be in such a hot area of research,” Shalwitz said. “The recognition of the importance of this compound has increased dramatically over the last 10 years and is now widely acknowledged to be a critical cellular signal. You always want to be in good science, but now to find out that we are in great science, and part of something much larger is very exciting.”

Invirsa sets out to battle viral conjunctivitis (viral pinkeye).

Viral conjunctivitis (also called viral pinkeye) is an acute eye infection commonly caused by adenovirus. Viral pinkeye is highly contagious and there can be community-wide outbreaks.  In addition, adenovirus conjunctivitis has the potential to cause serious eye injury.

At present, there is no approved medical treatment for viral conjunctivitis. The common course of the disease can range from one to three weeks.  More severe cases can last for months. Antibiotics, which are frequently prescribed, provide no benefit.

The Invirsa compound, which exists naturally in every human cell, modifies the body’s cellular response to encourage clearance of the virus and to more rapidly resolve the viral induced injury

“There is a beauty in this compound and how it interfaces with pathways in the cell,” said Shalwitz.

“It affects the way certain proteins operate and by doing so it improves the innate immune response, making it better for wound healing, minimizing inflammation, and reducing viral replication. Of course, the best way to treat disease is to enhance the body’s own ability to fight the disease,” he said.

Based on encouraging results of early testing, Invirsa has raised outside capital, including investment from Rev1. The funding will be used to further protect and patent the firm’s intellectual property, and to pay for additional testing.

The next steps for Invirsa are to finalize the formulation and manufacturing process, and move into toxicology studies and human trials.

What it’s like to be a biotech startup in the heart of Ohio.

Shalwitz has more than 20 years’ experience in drug discovery, development, FDA approval and marketing support. He has been engaged in research since his pediatric endocrinology fellowship at Washington University in St. Louis.

He was medical director for Pharmaceutical R&D at Abbott, and co-founder and Chief Medical Officer of Akebia Therapeutics, which went public in 2014.

Shalwitz says that starting a biotech company in Ohio isn’t like being in Boston—but that there are plenty of Midwestern resources and the benefits of the backyard effect.

“Central Ohio has many of the necessary resources for drug development. There’s a great medical infrastructure including OSU, Nationwide Children’s OU and Battelle. We have chemical manufacturing close by, drug manufacturing in Cincinnati, and formulation development in Cleveland and Kentucky.”

The business model for Invirsa is capital efficient.

“While most new drugs require $50MM to $200MM to get through Phase 2 (mid-stage human clinical trials), by focusing on short term topical therapy we can get into Phase 2 development for $10MM, with the possibility of gaining a partnership at that point,” Shalwitz said.

“The investor core isn’t biotech,” he said, “but Rev1 is helping to identify additional investors, and to utilize local connections. In addition, the contacts and friendships from my years in research have been invaluable during this process.”

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