Pharma

Thermalin Diabetes gets $4.5M NIH grant for next-generation insulin

Next-generation insulin developer Thermalin Diabetes has received a $4.5 million grant from the National Institutes […]

Next-generation insulin developer Thermalin Diabetes has received a $4.5 million grant from the National Institutes of Health to continue development of its insulin analogs.

The grant is expected to fund Cleveland-based Thermalin through the filing of an investigational new drug (IND) application for a rapid-acting insulin analog drug candidate, CEO Rick Berenson said.

“We are very excited about this grant because, in addition to providing vital, nondilutive support for our efforts, it represents significant, peer-reviewed validation for our science,” Berenson said.

The company’s portfolio of insulin analogs — new proteins engineered to act like insulin in the body — can offer several advantages over the natural hormone. For example, the analogs can be heat resistant or can be engineered to act more quickly or slowly than insulin, depending on a diabetic’s needs.

The latest grant, through the federal government’s Small Business Innovation Research (SBIR) program, will fund formulation development as well as animal safety and toxicity studies, which are required before the company’s drug candidate can be legally tested in humans. Thermalin has received a total of $6.5 million in NIH funding over its lifetime.

Thermalin hopes those animal studies pave the way for its first clinical trial, which would come after the company files its IND. Berenson is targeting the first half of 2013 for the IND filing.

Leaving aside Thermalin’s science — which by all accounts looks promising — the company figures to be attractive to investors due to the sheer size of the market for insulin. With worldwide cases of diabetes expected to explode over the next few decades, so too will the market for insulin.

Berenson pegs the annual worldwide market for insulin at $14 billion and expects it to grow to $70 billion in 20 years.

“Insulins on the market today work well for many people, but are problematic for others,” Berenson said.  “As we continue to expand our understanding of these unmet needs, we are adding to our early stage pipeline new target profiles for specialty insulins that solve specific problems for patients.”

Thermalin’s team has expanded recently, adding a vice president of strategic relationships, and the company is also hiring for several other positions, including a chemist and quality assurance manager.

Thermalin’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.

The company is targeting a series B investment of between $8 million and $10 million. It expects to do an early close of between $1.5 million and $2.5 million in convertible debt that would act as a “bridge financing,” Berenson said.

[Photo from flickr user Melissa]

 

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