a long-lasting (pegylated) version of C-peptide that would require just one dosage per week.
Diabetes-associated nerve dysfunction can be a problem, Martin explains, because the loss of sensation mens a patient often can’t feel skin irritations or something as commonplace as a pebble in the shoe. As a result, they can develop skin sores that are difficult to heal. Martin says such sores are the biggest cause of diabetic amputations in the United States.
In a statement today, Cebix says its once-weekly C-peptide therapy (Ersatta) was well-tolerated and showed no adverse effects in a 12-week trial of 72 patients that focused on safety, tolerability, and pharmacokinetics.
With the successful completion of the trial, Cebix said it also closed on a $30.9 million Series B round that included existing investors InterWest, Sofinnova Ventures and Thomas, McNerney & Partners. With $16.8 million raised previously through the company’s Series A round, Martin says Cebix has raised a total of nearly $48 million.
Cebix says proceeds of the Series B round will be sufficient to fund its operations through a mid-stage trial scheduled to begin early next year. Cebix has been operating as a virtual biotech, operating with just eight employees and relying on contract research organizations (CROs) to carry out most of the R&D. In terms of the company’s strategy, “it’s down to execution now,” Martin says.
Martin was previously the CEO of Altair Therapeutics, a San Diego startup developing an inhaled anti-inflammatory drug for treating asthma. He says a mid-stage trial showed the drug was not efficacious and the assets were sold. Before joining Altair, Martin was a partner at Forward Ventures, the San Diego life sciences venture firm.
The upcoming test has been designed to assess any improvement in nerve conduction velocity in among 240 patients over a year of self-administered weekly C-peptide replacement therapy. The study also will evaluate other prospective measures of neuropathy as well as symptoms and biomarkers of nephropathy.
The company says there are no approved disease-modifying therapeutics for diabetic peripheral neuropathy. As a result, the FDA has scheduled a public workshop in early 2013 to discuss the development of such drugs.
