Cebix Incorporated has announced results of a phase I/II 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 at the Annual Meeting of the European Association for the Study of Diabetes.
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.”
“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 IIb trial in early Q1 2013,” said Dr Martin. The upcoming phase IIb 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 IIb trial.
Dr Martin was most recently the president and CEO of Altair Therapeutics, a phase II 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, 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, 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.