MDRNA Announces Phase 2 Trial Of PYY(3-36) Does Not Meet Weight Loss Endpoint

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 04 Aug 2008 - 2:00 PDT

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MDRNA, Inc. (Nasdaq: MRNA) announced results from a Phase 2 clinical trial evaluating PYY(3-36) Nasal Spray (PYY) for the treatment of obesity. The data indicate that PYY did not meet the primary efficacy endpoint of a dose response of weight loss vs. PYY dose, nor did PYY meet the secondary efficacy endpoint of greater weight loss than the active control, sibutramine (Meridia®).

"The study demonstrates that our tight junction technology effectively delivers PYY into the body via nasal administration, but that the peptide itself is not effective as a single agent for weight loss," stated Gordon Brandt, M.D., President. "We are pleased that once again our delivery technology has effectively and safely delivered a large molecule via the intranasal route with good tolerability but disappointed that PYY did not show more promising therapeutic effect. We believe our intranasal delivery technology continues to demonstrate value as a means of safely administering peptides and proteins and believe that PYY might still prove effective in combination with other weight loss drugs. We would like to thank the investigators, staff and patients who participated in the trial."

Consistent with prior clinical experience, the most common adverse event for patients dosed with PYY was transient, dose related nausea. Nasal adverse events were similarly low between the Company's proprietary delivery formulation and the saline nasal spray control, demonstrating good tolerability of the proprietary delivery formulation. In comparison to some other obesity programs in development, there were no occurrences of depression or suicidal thoughts in the patients receiving PYY at any time during the six-month study.

Phase 2 Study Design

The 24-week, blinded, randomized, placebo-controlled dose-ranging trial in healthy obese patients evaluated three different doses of PYY Nasal Spray compared to placebo and sibutramine (Meridia®), with the primary endpoint being weight loss. Patients in the nasal spray treatment arms took PYY Nasal Spray or saline nasal spray placebo three times daily prior to a meal over the 24-week period. The study design enabled patients to undergo an initial dose titration period to establish an optimal dose to continue over the duration of the trial.

About PYY(3-36)

PYY is a naturally occurring hormone that is believed to function as a physiologic inhibitor of food intake. PYY is released into the blood stream from specialized cells in the gut after a meal and is believed to trigger the feeling of satiety, or fullness. Because PYY is a peptide, initial studies focused on PYY delivery by injection. Utilizing its proprietary drug delivery technology, Nastech developed the nasal spray formulation of PYY as a unique, non-invasive treatment option for obesity.

About Obesity

There are approximately 1.6 billion overweight adults worldwide, 400 million of whom are clinically obese according to World Health Organization. Obesity is a heterogeneous disease encompassing multiple redundant and compensatory biological processes, any of which may contribute to a person's inability to lose weight. Obesity has been identified as a risk factor in chronic diseases including type 2 diabetes, cardiovascular disease and hypertension. Treatment options against novel targets such as PYY using patient friendly routes of administration such as intranasal delivery may provide significant therapeutic benefit for those suffering from this condition.

About MDRNA, Inc.

MDRNA, Inc., formerly Nastech Pharmaceutical Company Inc., is a biotechnology company developing RNAi-based therapeutics. The Company's primary focus is on the safe and effective delivery of siRNA drug candidates for the treatment of a wide range of human diseases, including inflammation, viral infections, cancer and metabolic disorders. MDRNA will continue to leverage its expertise and capabilities toward innovation in novel and useful RNA-based compositions in order to increase the value proposition of MDRNA to investors and partners. Additional information about MDRNA, Inc. is available at http://www.mdrnainc.com.

MDRNA Forward-Looking Statement

Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of MDRNA or a subsidiary to obtain additional funding; (ii) the ability of MDRNA or a subsidiary to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of MDRNA, a subsidiary and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of MDRNA, a subsidiary and/or a partner to obtain required governmental approvals; and (v) the ability of MDRNA, a subsidiary and/or a partner to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in MDRNA's most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. MDRNA assumes no obligation to update and supplement forward-looking statements because of subsequent events.

MDRNA, Inc.