In a move intended to advance its most promising drug candidate while conserving capital, Insmed Inc. restructured its operations, reducing its work force by 55 percent.
SomatoKine, a biotherapeutic agent being developed as a growth-promoting/anabolic agent and insulin sensitizer, is Insmed's lead product candidate, in Phase II development for growth hormone insensitivity syndrome (GHIS) and diabetes.
The company plans to initiate a pivotal clinical trial of SomatoKine, approved for orphan drug status in GHIS, in early 2003 and to continue its Phase II development in Type I and Type II diabetes in 2003. SomatoKine is the recombinant form of human insulin-like growth factor-I and its regulatory binding protein, IGFBP-3.
Insmed Vice President of Corporate Development Mary Callan told BioWorld Today that SomatoKine also is in "very preliminary" studies in osteoporotic hip fracture surgery and burn trauma.
The company had about 60 employees before the restructuring. Insmed expects the reduction to give it at least two years' cash reserve. It had $36.3 million in cash at the end of the second quarter.
Insmed is "very much in good shape" following the restructuring, Callan said.
The company has not partnered heavily in the past and she said it now will focus more on partnering compounds in different stages of development.
"The partnering opportunity is something we can take advantage of," Callan said. "With a company at our stage and our size we do have a lot of opportunities."
The Richmond, Va.-based company recently discontinued development of INS-1, following poor results from a Phase II study in Type II diabetes and polycystic ovary syndrome. The candidate appeared to be safe and well tolerated, Insmed said, but failed to achieve statistical significance on its primary efficacy measures. However, Callan said INS-1 was the company's lead compound merely in the chronological sense and its failure does not reflect the potential of other candidates. (See BioWorld Today, Sept. 11, 2002.)
Insmed also has in preclinical development IGFBP-3, or insulin-like growth factor binding protein-3, an agent that has shown promising antitumor activity. The company expects to file an investigational new drug application in the second half of 2003. IGFBP is a naturally occurring antitumor agent that in preclinical studies enhanced standard-of-care therapy and has shown comparable efficacy as a sole treatment against cancer in animal models, Insmed said.
Insmed's stock (NASDAQ:INSM) rose 3 cents Monday to close at 46 cents.