May 22, 2012
Unigene Laboratories, Inc. (OTCBB: UGNE)
a leader in the design, delivery, manufacture and development of peptide-based therapeutics today reported positive data from recently completed preclinical studies in rats and dogs for its lead proprietary anorexigenic peptide, UGP281.
UGP281, a potent anorexigenic peptide selectively targeting the amylin receptor, is under development by Unigene for the treatment of morbid obesity. In multiple-dose pharmacology studies in rats and beagle dogs, UGP281, administered subcutaneously, produced a dose-related decrease in body weight of 10-15% over a 7-day treatment period. The reduction in food intake was acute and dramatic, falling close to zero at relatively low doses, and was consistent with the targeted pharmacology. Changes in body weight throughout the studies were tightly aligned with decreases in food consumption. UGP281 was well tolerated with no overt adverse findings in the studies conducted to date, and its therapeutic window appeared to be substantial.
These data compare favorably to what has been described preclinically with other weight loss compounds currently, or previously, under development. Additionally, since UGP281 does not bind to serotonin receptors, the risk of unwanted cardiovascular effects is expected to be significantly less as compared to other obesity product candidates.
Furthermore, as successfully demonstrated in previous preclinical studies, UGP281 has the potential to be dosed orally and manufactured recombinantly by way of Unigene's Peptelligence™ technology platform.
Frank L. Greenway
, MD, Professor and Director of Outpatient Clinical Research,
Baton Rouge, LA
, commented, "The preclinical data seen with Unigene's peptide, UGP281 are very exciting. The robust effects on food consumption and body weight loss demonstrated in the recently reported rat and dog models confirm Unigene's prior preclinical studies. These results support the Company's plans to commence Phase 1 clinical testing in obese subjects next year and indicate that, if these results can be reproduced in humans, UGP281 could potentially offer a new and very exciting treatment option in an area that clearly needs new and better treatments."
, PhD, Unigene's VP, Research and Development stated, "We are extremely pleased with our progress with UGP281 and continue to build an encouraging preclinical data set for our lead proprietary metabolic peptide." Dr. Mehta continued, "UGP281's selective receptor-binding is anticipated to result in a cleaner and more attractive safety profile relative to several of the small molecule drug candidates or drug combinations currently, or previously, in development. We continue to further differentiate UPG281 from other potentially competitive, peptide-based drugs and drug candidates and believe we will have the opportunity to optimally position UGP281 in this rapidly growing and significantly underserved market space."
Unigene is currently preparing for the submission of its Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) and expects to be able to commence Phase 1 clinical testing of UGP281 in the first half of 2013.