December 25, 2012

Good Tidings for C-peptide Replacement Trial

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c-peptideIt has been an object of my desire since I first learned about c-peptide in 2007. A study has demonstrated that C-peptide replacement therapy protects against complications of T1D.

One of the researchers championing c-peptide is Dr. John Wahren. He is the Chief Scientific Officer and a board member of Cebix, the company serving the unmet needs of people with T1D everywhere.

The missing link to prevent T1D complications has been under our nose all along. Despite tight control, 60-70% of people with T1D develop complications. C-peptide replacement therapy is long overdue for the treatment of long-term complications of T1D.

The connecting peptide or C-peptide hormone is normally produced in conjunction with insulin, is absent in type 1 diabetic patients. Although it has been known about since the discovery of insulin, it was dismissed as biologically inactive.

In October 2012 Cebix announced positive results from the c-peptide replacement trials. The trial demonstrated the safety and efficacy of ERSATTA. This novel drug is the first once-weekly C-peptide therapy to target loss of nerve function and other vascular complications in T1D.

In the 12-week study, 72 subjects administered weekly injections of ERSATTA. The trial proved that the drug is well tolerated with no serious adverse effects. In addition to the drug proving to be safe, it demonstrated  favorable efficacy in patients who self-injected ERSATTA.

So far, so good. Seasoned investors can smell a blockbuster drug miles away. This is why Cebix announced securing over $30 million in a Series B investment. This means that the company is filling a high unmet need and the burden of proof is compelling. In other words, this thing has legs.

Although Cebix is flying high with the initial news of what ERSATTA brings to the table for T1D therapy, the rest of us are waiting with bated breath. Never fear. The upcoming phase 2b trial is designed to show improvement in  nerve conduction velocity (NCV) in 240 people.

Phase 2b will also  include dysfunctions such as: vibration sensation, neurological status, erectile dysfunction and quality of life. The aforementioned tests include, but are not limited to, different markers of nephropathy.

Maybe the FDA will take a page from the history books of approving insulin analogues and consider the Fast Track FDA approval of c-peptide. C-peptide is already on my wish list for Christmas next year.

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