Cebix Announces Positive Results of ERSATTA Phase 1/2 Trial Targeting Peripheral Neuropathy in Type 1 Diabetics
$30.9M Series B Investment closed and Joel Martin appointed as President and CEO
LA JOLLA, Calif., Oct. 17, 2012 /PRNewswire/ -- Cebix Incorporated, a biopharmaceutical company developing treatments for complications of diabetes, today announced results of a Phase 1/2 trial of its lead investigational drug, ERSATTA™ in peripheral neuropathy. ERSATTA is the first once-weekly C-peptide therapy to target loss of nerve function and other vascular complications in type 1 diabetes patients. The successful 72 subject trial, which focused on safety, tolerability, and pharmacokinetics, demonstrated that ERSATTA was well tolerated, with no serious adverse effects over a twelve week period. The pharmacokinetic profile supports convenient, once weekly dosing. The trial further demonstrated a favorable efficacy signal in type 1 diabetic patients who self-injected ERSATTA once weekly over the 12-week period. Both the safety and efficacy results were consistent with results from prior published clinical trials of native C-peptide. Top line results of the ERSATTA study were presented on October 4 th, 2012 at the Annual Meeting of the European Association for the Study of Diabetes (abstract #1110).
In parallel with the successful completion of the trial, the company also announced the closing of a $30.9M Series B investment and the appointment of Dr. Joel Martin as President and CEO. Prior investors InterWest, Sofinnova Ventures and Thomas, McNerney & Partners all participated in the financing. "We are extremely pleased with the results of the ERSATTA trial," said Dr. Martin, "which demonstrated outstanding safety and pharmacokinetic profiles." According to the US National Institutes of Health, approximately 60 to 70% of type 1 patients develop peripheral neuropathy, and more than one million patients suffer from the condition in the US alone (www.diabetes.org). "These data results, combined with the elegance of the potential ERSATTA product and the promise of addressing a high unmet need in an important patient population were all compelling reasons to take on the CEO role at Cebix," said Dr. Martin. There are no approved disease-modifying therapeutics for diabetic peripheral neuropathy. In view of this unmet medical need, the FDA has scheduled a public workshop in early 2013 to discuss the development of such drugs.
"Cebix is well-positioned to launch our Phase 2b trial in early Q1 2013," said Dr. Martin. The upcoming Phase 2b trial is designed to demonstrate improvement in nerve conduction velocity in a multi-dose, 240 patient trial over one year of self-administered weekly therapy. The study will also evaluate several other measures of neuropathy, including vibration sensation, neurological status, erectile dysfunction and quality of life, as well as symptoms and markers of nephropathy. The Series B proceeds will fully fund the company through the Phase 2b trial.
Dr. Martin was most recently the President and CEO of Altair Therapeutics, a Phase 2 asthma company which was acquired in 2010. Dr. Martin was also a partner at Forward Ventures from 2001 through 2008, where he led investments in neuroscience and oncology companies including Hypnion, Predix and Cellective Therapeutics. Said Dr. David Kabakoff, PhD, Executive Partner at Sofinnova and Chairman of the Cebix Board of Directors, "Joel Martin is an outstanding addition to the Cebix team. Through his background as a successful serial entrepreneur, venture investor and respected scientist, Joel brings an experienced, multidisciplinary approach to his role as CEO. We look forward to working with him as Cebix enters the next important phase in its clinical development."
Dr. Martin was co-founder and CEO of Quantum Dot Corporation (acquired by Life Technologies), a pioneer in nanotechnology applications in the life sciences, as well as co-founder and CEO of Argonaut Technologies, a chemistry automation company (formerly NASDAQ: AGNT), which was acquired by Biotage AB. Dr. Martin earned his PhD in Physical Chemistry from the University of California San Diego, and holds MBA and BS degrees from the University of Michigan, Ann Arbor.
About Cebix Incorporated
Cebix is developing ERSATTA, a C-peptide replacement therapy for the treatment of long-term complications of diabetes. C-peptide hormone, normally produced in conjunction with insulin, is absent in type 1 diabetic patients. Clinical trials of native C-peptide have demonstrated salutary effects on diabetic neuropathy, nephropathy and retinopathy. The company is based in La Jolla, California. For more information, visit www.cebix.com.
Joel Martin, PhD
President & CEO
Jennifer James on behalf of Cebix
SOURCE Cebix Incorporated
Web Site: http://www.cebix.com
Posted: October 2012