Unigene : Positive Advanced Preclinical Data for UGP281 a Potent, Orally Delivered Anorexigenic Peptide

Jun 27, 2011 - UGP281 demonstrated significant and sustained weight reduction over several weeks using oral formulation - Unigene expects to file IND and commence Phase 1 studies in 1H 2012 - Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced that the Company presented positive preclinical data for UGP281, its potent, orally-delivered anorexigenic peptide as a late-breaking poster presentation at the American Diabetes Association (ADA) 71st Scientific Sessions being held June 24-28 in San Diego, California.

Poster Presentation

Titled: "Preclinical Studies with UGP281, a Potent, Orally Delivered, Anorexigenic Peptide", and authored by N. Mehta, W. Stern, A. Sturner, S. Carl, V. Ray, A. Conslavo, C. Sisk, F. Ritacco, N. Souders, S. Pennington, J. Jiacchi, K. Veintimilla, C. Meenan, A. Vryhoff and A. Bolat.

Summary

UGP281 is a peptide hormone analog that shows an acute dramatic reduction in food intake in a rat model at low doses. The peptide has been produced by recombinant expression in E. coli and has also been formulated in enteric-coated capsules for oral delivery. The effect of UGP281 on food intake and body mass has been investigated in several preclinical studies. In a 20 day chronic dosing study, young rats injected daily with UGP281 at doses of 5 ug/kg and 20 ug/kg exhibited an immediate acute dose dependent reduction in food intake of 55% and 84%, respectively and a sustained weight loss relative to placebo of 5.7% and 8.8%, respectively. A placebo-controlled study in Beagle dogs with enteric-coated capsules containing UGP281 demonstrated a sustained weight reduction of >8% compared to placebo for a period of 5 weeks. In comparative studies at comparable concentrations, UGP281 demonstrates greater reductions in body weight than other peptide drugs currently in development. Based on the results to date, UGP281 was well tolerated and offers the potential of a patient friendly orally dosed peptide therapy for the management of obesity... Unigene Laboratories' Press Release -

AMRI : Successful Completion of Phase I Clinical Study of Obesity Compound

May 31, 2011 - Phase 1 data support the continued development of ALB-127158(a) as a potential treatment for obesity — AMRI (NASDAQ: AMRI) announced the results from its Phase I clinical study on its novel MCH1 receptor antagonist, ALB-127158(a). The results indicate that ALB-127158(a) is well tolerated at the doses tested and shows preliminary evidence of efficacy.

The results were presented at the 18th European Congress on Obesity by Dr. Nicholas Moore, director of development and pharmacology at AMRI. The placebo-controlled study evaluated the safety, tolerability and efficacy of ALB-127158(a) in male volunteers. The study consisted of three components: a single ascending dose arm (SAD) in lean subjects (BMI ≤ 25), a fed/fasted crossover in overweight subjects (BMI ≥ 27) and a 14-day ascending dose arm (MAD) in overweight subjects. Standard safety assessments, ECG monitoring and PK measurements were conducted.

ALB-127158(a) was well tolerated in both the SAD and the MAD; reported events were mild and showed little dose relationship. One of the most common events reported in both the SAD and the MAD was loss of appetite. No drug-related changes in cardiovascular parameters or sleep were observed during any phase of the study. Reductions in “hunger,” “desire to eat,” and test meal consumption were observed. The study met both its primary and secondary objectives, demonstrating safety and tolerability. The data support the continued development of ALB-127158(a) as a potential treatment for obesity... AMRI's Press Release -