Strategy

Metal coordination is a platform technology with broad application that can be profitably applied both to already marketed drugs and to drugs under development. In a review of approximately 3,000 listed drugs, we found that over 400 had structures that allow metal coordination. Because the chemistry is relatively efficient and inexpensive to practice, we can create and gather preliminary data on compound candidates within a few months. Our ability to quickly develop preliminary data allows us to respond promptly to opportunities, to pursue multiple drug discovery programs concurrently, and to quickly identify and terminate projects that require excessive resources or are unlikely to succeed.

Metal Coordinated Pharmaceuticals (MCPs) enjoy significant regulatory advantages over other drug candidates. Because many MCPs are complexes or chelates of already approved drugs, we can often rely on existing data to demonstrate the efficacy and safety of those drugs. If the attached metal - which often represents a very small portion of the resulting compound - is generally regarded as safe, its presence raises no significant regulatory issue. If the metal is seldom used in pharmaceuticals, such as bismuth, or is potentially toxic, such as copper, we would establish the absence of potentially dangerous accumulation of the metal. Our ability to rely on existing data allows us to focus our efforts on demonstrating the benefits of the MCP over the reference drug and can substantially reduce the time and money spent in clinical development.

Unlike salts, MCPs are patentable as new compositions of matter under U.S. patent laws - even if the parent drug is already well known. For example, in addition to the patent office allowing claims for the FMDD compositions, our zinc-T3 and magnesium-furosemide complexes are also patented, even though T3 and furosemide have been used for decades. The combination of expedited FDA review and patent protection should give a metal coordinated pharmaceutical an unusually long period of market exclusivity.

We intend to develop our MCPs in partnership with other pharmaceutical companies and are pursuing a two-pronged approach to drug discovery and development partnerships. We are establishing proof of concept for MCPs that are strong candidates for out-licensing or development partnerships - primarily drugs whose efficacy or usage is significantly limited by absorption of other issues addressable through metal coordination. In addition, we intend to license our chemistry to pharmaceutical companies interested in addressing delivery or targeting issues with their pipeline drugs.

Intellectual Property

In September of 2010, the U.S. Patent and Trademark Office issued the first patent in Synthonics' portfolio. This composition of matter patent, which covers a complex of zinc with triiodothyronine (T3), establishes the patentability of novel molecules created by chelating a metal to a known drug. Synthonics has demonstrated that it can significantly improve a drug's absorption and delivery by chelating it to a metal, which should provide significant clinical benefits.

We are pleased to begin to build our intellectual property portfolio and expect additional patent grants on compounds derived from our Metal Coordinated Pharmaceutical (MCP) Platform," stated Kenneth Slepicka, Chief Executive Officer and co-founder. "This patent demonstrates our ability to obtain intellectual property protection for these novel compositions of matter and further validates the value of our metal coordination platform approach. We feel that this patent will be the first of many patents covering a wide array of applications and disease states."


Metal coordinated compositions (20 additional compositions) - U.S. Patent 8,389,726

March 5, 2013

A metal coordination complex of a biologically active moiety and a metal is disclosed. The complex confers to the biologically active moiety an improved performance which can include potency, stability, absorbability, targeted delivery, and combinations thereof.


Metal Coordinated Compositions (Zn T3) U.S. Patent 7,799,937

September 21, 2010

A coordination complex having a physiologically acceptable pK.sub.a includes a metal and a biologically active agent. The pK.sub.a of the coordination complex is less than the pK.sub.a of the biologically active agent. A pharmaceutical solution for treating a patient includes a coordination complex and water, wherein the coordination complex is at least partially soluble in the water at physiological pH and in a therapeutically efficacious concentration. A method for treating a patient includes administering a pharmaceutical solution including a coordination complex and water to a patient in need of a biologically active agent.


Metal Coordinated Compositions (Mg Furosemide) U.S. Patent 7,989,440

August 2, 2011

A metal coordination complex of a biologically active moiety and a metal is disclosed. The complex confers to the biologically active moiety an improved performance which can include potency, stability, absorbability, targeted delivery, and combinations thereof.


Frequency Modulated Drug Delivery (FMDD) – U.S. Patent 8,236,787

August 7, 2012

Embodiments of the present disclosure include a coordination complex, comprising a first biologically active moiety, a second biologically active moiety, and a metal, wherein the first biologically active moiety and second biologically active moiety are bound to the metal by covalent coordination bonds, and wherein the first biologically active moiety and second biologically active moiety are different. These complexes may enhance the pharmacodynamic properties of biologically active moieties.


Bismuth-Containing Compounds, Coordination Polymers, Methods for Modulating Pharmacokinetic Properties of Biologically Active Agents, and Methods for Treating Patients

Patent Application

Bismuth-containing compounds include bismuth and a biologically active agent coordinated to the bismuth. The biologically active agent includes at least one heteroatom configured for coordination with the bismuth. Coordination polymers include a polymer matrix that contains a bismuth-containing compound. Methods for modulating a pharmacokinetic property of a biologically active agent include coordinating the biologically active agent to bismuth to form a bismuth-containing compound, and administering the bismuth-containing compound orally to a patient. Methods for treating Parkinson's disease, methods for treating hypothyroidism, methods for treating ulcerative colitis, and methods for treating cancer each include administering a bismuth-containing compound to a patient.


Metal Coordinated Compositions

Patent Application

A metal coordination complex of a biologically active moiety and a metal is disclosed. The complex confers to the biologically active moiety an improved performance which can include potency, stability, absorbability, targeted delivery, and combinations thereof.


Coordination Complexes, Pharmaceutical Solutions Comprising Coordination Complexes, and Methods of Treating Patients

Patent Application

A coordination complex having a physiologically acceptable pK.sub.a includes a metal and a biologically active agent. The pK.sub.a of the coordination complex is less than the pK.sub.a of the biologically active agent. A pharmaceutical solution for treating a patient includes a coordination complex and water, wherein the coordination complex is at least partially soluble in the water at physiological pH and in a therapeutically efficacious concentration. A method for treating a patient includes administering a pharmaceutical solution including a coordination complex and water to a patient in need of a biologically active agent.