San Diego-based Cebix is moving ahead in its development of C-peptide replacement therapy for treating diabetes-related microvascular problems. Encouraging results from an early stage trial, reported earlier this month at the annual meeting of the European Association for the Study of Diabetes, have led the company to raise an additional $30.9 million and to recruit veteran local biotech executive Joel Martin as CEO.
The company was founded in 2008 to advance the work of John Wahren, an emeritus professor of clinical physiology at Sweden’s Karolinska Institute. Wahren had helped determine that C-peptide plays a key role in keeping the smallest blood vessels healthy. The naturally occurring peptide is formed when insulin is cleaved from pro-insulin in the body.
Patients with type 1 diabetes, whose pancreases produce little or no insulin, are also susceptible to complications from microvascular deterioration, including loss of sensation (neuropathy), loss of kidney function (nephropathy), and loss of vision (retinopathy). The company estimates that roughly two-thirds of patients with type 1 diabetes develop peripheral neuropathy. In the U.S. alone that works out to more than 1 million people.
Wahren, a Cebix founder and the chief scientific officer, viewed C-peptide replacement as a potential therapy. In a phone interview earlier today, Martin said the problem was that C-peptide has a short half-life—which would require diabetics to inject themselves four times a day. Cebix has developed 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.
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