Next-generation insulin developer Thermalin Diabetes is targeting an $8 million series B round of investment that would fund the first in-human studies of its insulin analogs.
A successful clinical trial — though a long way off for the Cleveland-based company — would represent a huge milestone for Thermalin. CEO Rick Berenson said a positive trial would likely position the company for a potentially lucrative co-development deal with a big pharmaceutical company — and a liquidity event that would provide a return to the company’s investors.
Berenson would like to close the investment round by next year’s second quarter.
Thermalin is targeting the end of 2012 to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, which would likely enable the company to begin clinical trials in early 2013, Berenson said.
The company has already engaged in preliminary talks with potential pharmaceutical partners, but Berenson cautioned those talks are at an early stage. “They’re very interested in seeing the data as we develop it, but right now we’re just in relationship-building mode,” he said.
In the meantime, Thermalin plans to continue animal testing in preparation for beginning clinical studies.
The size of Thermalin’s potential market alone should catch investors’ eyes: A “staggering” 366 million people across the globe have diabetes and one person dies from the disease every seven seconds, according to the International Diabetes Federation. A study published earlier this year in the Lancet found that nearly 10 percent of the world’s adults have diabetes and the prevalence of the disease is rising rapidly.
Thermalin says insulin is a $14 billion worldwide market that will grow to $70 billion in 20 years.
The company’s insulin analogs — new proteins engineered to act like insulin in the body — are heat resistant, unlike the natural hormone, and can be engineered to act more quickly or slowly than insulin, depending on a diabetic’s needs. The company’s insulin analogs were engineered by Michael Weiss, the chairman of the Biochemistry Department at Case Western Reserve University School of Medicine and Thermalin’s chief scientific officer. Weiss and Berenson were roommates at Harvard University.
Weiss has developed about 80 different versions of insulin analogs and Thermalin has been busy with animal testing to cull that down to four to commercialize, with each of those four possessing different characteristics.
For example, one of the four is an “ultrarapid-acting” insulin that has been shown to act 30 percent more quickly than what’s currently on the market. Another version is formulated at a concentration five times greater than what’s currently on the market and would be targeted toward patients suffering from extreme insulin resistance.
Thermalin has raised $2.9 million in equity since it was founded, with investors including Cleveland nonprofit venture development group JumpStart and individual angels. The company has also pulled in about $2.3 million in grants, most through the federal government’s Small Business Innovation Research (SBIR) program.