Omeros Corporation Announces Positive Results from Phase 1 Study of its Lead PDE7 Inhibitor in Development for Addiction
-- Phase 1 study results show excellent safety and PK profile consistent with once-daily dosing --
In the double blind, randomized Phase 1 study, the study drug, referred to as OMS182399, was administered to 47 healthy volunteers and met the primary endpoints of safety and tolerability. In the single-ascending-dose part of the study, fasted subjects received single oral doses of placebo or OMS182399 in five sequential ascending-dose cohorts. The study also included a single-dose cohort in non-fasting (i.e., fed) subjects. In the multiple-ascending-dose part of the study, non-fasting subjects received oral doses of placebo or OMS182399 once a day for 14 days in three sequential ascending-dose cohorts.
The study demonstrated that OMS182399 was safe and well-tolerated over the dose ranges tested. The number of subjects reporting any treatment-emergent adverse event (TEAE) was 2 out of 12 (16.7 percent) and 8 out of 35 (22.9 percent) in the placebo and active groups, respectively. All TEAEs were mild in intensity and transient, the most frequent being headache; no serious AE or lab-related AE was reported, and there was no dose dependency of AEs observed. No TEAE occurred in the highest dose group in the single-ascending-dose part of the study (n=6).
Importantly, OMS182399 showed a favorable and dose-proportional pharmacokinetic (PK) profile supporting once-daily dosing, and there was no apparent food effect on plasma exposure to OMS182399.
"We are pleased with the results of our OMS527 Phase 1 study," said
Preclinical data show efficacy across multiple types of addiction and compulsive disorders, including nicotine, cocaine, opioids, alcohol, and binge eating. Omeros’ PDE7 inhibitors reduce craving and relapse but do not appear to be addictive nor to depress pleasure from normal activities (e.g., social interaction, sex, eating, etc.), both of which are often shortcomings of current commercial addiction therapies. Tens of millions of people in the U.S. suffer from substance addiction, with an estimated societal cost of nearly
The initial target planned for the OMS527 program is nicotine addiction. The single largest preventable cause of death and disease in the U.S. is tobacco use, with a national death toll of nearly half a million people annually. Smoking-related illness in the U.S. costs over
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “prospects,” “should,” “slated,” “targeting,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding Omeros’ research and development programs and the therapeutic application of Omeros’ research findings, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, uncertainties inherent in research and development such as the risk that results of future clinical or preclinical studies may be different from those suggested by earlier results, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K filed with the
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Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations