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Cebix Initiates Phase 1b Clinical Trial with Drug Candidate Ersatta™

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Cebix Initiates Phase 1b Clinical Trial with Drug Candidate Ersatta™ Jun 2011

Company Addressing Chronic Complications of Diabetes with C-Peptide Replacement Therapy

16 June 2011

LA JOLLA, Calif. — Cebix Incorporated announced today it is advancing the development of modified C-peptide for the treatment of complications of diabetes. The biopharmaceutical company has initiated a Phase 1b clinical trial to evaluate Ersatta™, its proprietary long-acting form of C-peptide, in patients with type 1 diabetes who, because of their disease, lack this endogenous peptide. Following the successful completion of this study, the company is planning a mid-stage clinical program in diabetic peripheral neuropathy and other chronic conditions associated with diabetes that may be reversed by replacing C-peptide.

The primary objectives of the randomized, blinded, placebo-controlled Phase 1b study are to assess the safety, tolerability as well as single and multiple dose pharmacokinetics of Ersatta after subcutaneous administration. The study is estimated to enroll 30-60 patients and will be conducted at up to six sites in the U.S.

Ersatta, a proprietary, mono-pegylated version of C-peptide, has improved pharmacokinetic properties compared to the native peptide. Pegylation of C-peptide extends the drug half-life, allowing for once-weekly dosing, which enhances patient compliance. Ersatta has been shown to improve nerve function in preclinical studies in a rat diabetic neuropathy model. Cebix has defined the pathway to marketing approval for Ersatta under U.S. Food and Drug Administration (FDA) subpart H. Nerve conduction velocity will therefore be the sole primary endpoint for a Phase 2/3 pivotal trial in diabetic peripheral neuropathy, which Cebix plans to initiate in the first half of 2012. Cebix has been granted fast track status by FDA for Ersatta in the diabetic peripheral neuropathy indication.

To date, Cebix has raised $30.5 million in Series A financing and established a database of 19 clinical studies evaluating native C-peptide in more than 300 patients with type 1 diabetes. These studies demonstrate that C-peptide replacement therapy increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. To date, native C-peptide replacement therapy has an excellent safety profile.

"There are approximately four million patients with type 1 diabetes in the U.S. and Europe. Of these, about 4 out of 5 will eventually experience abnormal function of the peripheral nerves, and this deficiency can lead to diabetic foot disease, and potentially amputation," said James Callaway, Ph.D., President and CEO of Cebix. "We are eager to advance the Ersatta program, which has the potential to reverse the chronic complications of diabetes, unlike other currently available products simply directed at symptomatic relief."

"Cebix has a wealth of scientific and clinical data as our strong foundation for further exploring the benefit of replacing C-peptide in patients with diabetes," said John Wahren, M.D., Ph.D., Chief Scientific Officer of Cebix. "We successfully created a long-acting form of C-peptide to improve the drug profile for patients and physicians and have initiated our first clinical trial with first-in-class Ersatta in patients with type 1 diabetes."

Dr. Wahren, Professor Emeritus of Clinical Physiology at the Karolinska Institute in Stockholm, Sweden, and colleagues elucidated the physiological role of C-peptide in diabetes, demonstrating that deficiency of C-peptide in diabetes contributes to the progressive damage of the peripheral and autonomic nerves and the kidneys. Replacement of C-peptide was found to exert beneficial effects on the long-term complications of diabetes involving the nerves and the kidneys.

Cebix was co-founded in 2008 by Dr. Wahren and Lars Ekman, M.D., Ph.D., Executive Chairman of the company. Seed financing was spearheaded by Sofinnova Ventures with support from angel investors. A subsequent financing for $28 million was led by Thomas McNerney & Partners along with InterWest Partners and Sofinnova Ventures. The company leadership team has extensive experience in drug and biologics development, including the submission of more than a dozen new drug or biologics license applications. Having worked together in senior level roles at Elan Pharmaceuticals, Drs. Callaway and Ekman have a long track record of success, jointly leading teams to deliver first-in-class therapies to market.

The leadership at Cebix was recently expanded with the addition of Howard Foyt, M.D., Ph.D., FACP, as Senior Vice President and Chief Medical Officer. Dr. Foyt is an endocrinologist who for the past 15 years has led pharmaceutical R&D teams focused on metabolic diseases. Previously Dr. Foyt served as Therapy Site Head – Diabetes & Obesity at Pfizer Global Research & Development and oversaw large clinical studies in diabetic peripheral neuropathy.
About C-Peptide in Diabetes

C-peptide is a naturally-occurring peptide that is formed when insulin is cleaved from pro-insulin. In healthy individuals, C-peptide and insulin are co-secreted by the beta cells in the pancreas. Researchers initially concluded that C-peptide was merely a by-product of the excision of insulin from the larger pro-insulin molecule, but Dr. Wahren demonstrated it to be a bioactive peptide in its own right, contributing to the preservation of microvascular health of multiple organ types.

Type 1 diabetes is characterized by the body's inability to produce pro-insulin and consequently both insulin and C-peptide. Because C-peptide deficiency has only recently been implicated in vascular microcirculation dysfunction, treatment today for type 1 diabetes is limited to intensive insulin therapy and frequent blood glucose monitoring to optimize glycemic control. Type 1 and some type 2 diabetic patients have a C-peptide deficiency, which can cause a reduction in microvascular circulation, resulting in progressive damage to the nerves, retina and kidneys.
About Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy involves symmetrical abnormalities of the sensory nerves in the feet, the lower legs and eventually the arms, resulting from poor microcirculation to the nerves. The symptoms include numbness or insensitivity to pain or temperature, and a tingling, burning, or prickling sensation that begins in the fingers and toes and progresses up the arms and legs. Patients may experience sensory loss, leading to difficulties with balance, coordination and walking. People with diabetes can develop nerve problems at any time, but risk rises with age and longer duration of diabetes, and for patients who are overweight or have poor control of their blood glucose.
About Cebix Incorporated

Cebix is developing Ersatta™, a C-peptide replacement therapy for the treatment of long-term complications of diabetes. The company is based in La Jolla, California. For more information, visit www.cebix.com.

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