Altheus Therapeutics, Inc. announced the USPTO has allowed patent 8,629,127 B2 covering the oral pharmaceutical composition 5-ASA (5-aminosalicylic acid) and NAC (N-acetylcysteine). Combination therapy patents are uncommon and under-appreciated in the pharmaceutical industry because the Patent Office requires surprising, unexpected, or synergistic benefits from combining active ingredients into a single formulation. Altheus' success in procuring the strong and diverse patents for Zoenasa, including this most recent oral combination therapy patent, stems from rigorous studies demonstrating highly statistically significant synergy between Zoenasa's two components.
"Zoenasa operates under a patent portfolio that rivals that of a brand name drug in its strength and diversity of protection," commented Dennis Schafer, President and CEO of Altheus. "The issued patent claims extend patent coverage to Zoenasa Rectal Gel and oral therapy for treatment of inflammatory bowel disease into 2030."
Nearly 1.2 million Americans suffer from inflammatory bowel disease. The two most common forms, ulcerative colitis and Crohn's disease, are chronic lifelong conditions which significantly impact quality of life. Current front-line treatment for ulcerative colitis is monotherapy with oral or rectal mesalamine. However, many patients do not achieve symptomatic or endoscopic remission and must escalate to more expensive and burdensome immunosuppressive treatments.
Zoenasa, a novel combination of two FDA-approved drugs with well-established efficacy and safety profiles, has been shown to act synergistically to improve the signs and symptoms of ulcerative colitis. In animal models of colitis, Zoenasa resolved inflammation more rapidly and completely than mesalamine alone.
Zoenasa Rectal Gel is being investigated for the treatment of left-sided ulcerative colitis, which affects approximately 80% of ulcerative colitis patients. The ZA201 clinical trial is a 6-week, double-blind, active-controlled Phase 2 study of the efficacy and safety of Zoenasa Rectal Gel versus mesalamine enema therapy. The study has completed enrollment and will return results in Spring 2014.
The U.S. Food and Drug Administration granted Zoenasa orphan designation for the treatment of pediatric ulcerative colitis. An oral formulation of Zoenasa is in pre-clinical development and is expected to enter the clinic in 2014.
Altheus Therapeutics, Inc.,