Technology Platform
Amulet Pharmaceuticals, Inc’s therapeutic technology NORTECH™ brings several innovations to the treatment of gastrointestinal diseases. Since the early 1990’s the role of nitric oxide has been firmly established in the scientific literature. Amulet has developed a safe method to deliver the nitric oxide topically to the affected tissues in the stomach and GI tract.Our early studies have demonstrated the efficacy and safety of AMU-301 in vivo, and we are now seeking to commercialize AMU-301 though human clinical trials and develop a novel therapeutic for this underserved market.
Amulet’s nitric oxide delivery technology, NORTECH™ and AMU-301 delivers nitric oxide through a carbon-based (C-based) NONOate (Diazeniumdiolate) group in response to neutral and acidic pH. C-based NONOates cannot form carcinogenic breakdown products, unlike the nitrogen-based NONOates, greatly increasing the safety profile of the drug. Furthermore, NORTECH™ therapeutic polymers deliver •NO (physiologically active nitric oxide), a natural free radical produced in the body. NORTECH™ delivery of nitric oxide is triggered by pH only and does not require additional metabolic activation by the body, and unlike the organic nitrates, repeated treatment with NORTECH™ does not result in the development of tolerance.
Our lead compound, AMU-301, has a microporous hydrophobic polymer backbone where the acid-sensitive NONate groups sit deep in the polymer and are protected from the acidity of the stomach. The polymeric nature of AMU-301 allows it to release nitric oxide continuously over the entire duration of the gastric emptying process without being degraded. AMU-301 delivers targeted nitric oxide throughout the GI tract. The polymer scaffold of AMU-301 is identical to the scaffold of the approved drug Cholestyramine USP which has a long history of safe clinical use. The same polymer scaffold is also used as a GRAS (generally regarded as safe by FDA) food additive.
Insoluble, orally delivered polymers such as AMU-301 possess a distinct safety advantage over systemic drugs, as demonstrated by the short IND to approval times for insoluble polymers such as Renagel and WelChol, that progressed from IND to Approval within 3 years.
In addition to Amulet’s NORTECH™ therapeutic polymer program, we have a small molecule program with several leads in various stage of development in gastrointestinal diseases and osteoarthritis (pain).
We have filed PCT applications covering composition of matter claims for NORTECH™ technology (including AMU-301) in the US, Europe, Japan, Canada, Australia and India and in June 2007 filed a broadly based US provisional patent directly related to methods and compositions used to treat gastroparesis, including AMU-301. This provisional application is being filed as a PCT application in 2008. We also plan a utility patent application with method of use claims for treatment of gastroparesis using our own and other nitric oxide delivery compositions including reductions to practice.
Amulet core NORTECH™ technology is protected by international and U.S. Patent applications that provide a rich source of core intellectual property to support the company and provide a rich pipeline:
- PCT Patent Application # PCT/US2005/000174
- PCT/US2006/046214 Nitric Oxide-Releasing Polymers
- US provisional filing 60/924830 Compounds, Polymers and Methods for treating Gastrointestinal Dysfunction.
Amulet is responding to office actions on PCT/US2005/000174 and is filing a PCT patent application for 60/924830.