Anavex 2-73 Secures US Patent for Neurodegenerative Disorder Treatment

Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company, announced it was issued a new US Patent No. 12,180,174 entitled “A2-73 Crystalline Polymorph Compositions of Matter and Methods Of Use Thereof” from the United States Patent and Trademark Office (USPTO) for its US Patent Application Serial Number USSN: 17/978,818. This new patent claims crystalline forms of the dihydrogen phosphate salt of Anavex 2-73 (blarcamesine), freebase, transdermal patches and enteric coated oral dosage forms including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer’s disease, Parkinson’s disease and other disorders.

Anavex’s newest patent will be expected to remain in force at least until July 2039, not including any patent term extensions. It will expand and supplement the current Anavex 2-73 (blarcamesine) patent portfolio, which includes several US Patents, including US Patent Nos. 10,413,519; 10,966,952; 11,661,405; and 11,498,908.

“The issuance of this US Patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science,” said Christopher U. Missling, PhD, president and chief executive officer of Anavex. He further added: “We believe the unique properties of the dihydrogen phosphate crystals make it possible in addition to convenient once daily oral dosing to also deliver the active (Anavex 2-73 freebase) in transdermal patches, which could simplify further the administration and boost patients’ compliance. As such, we believe that the addition of the dihydrogen phosphate crystals to our platform could greatly benefit the patients at large.”

Crystal polymorphism is a unique phenomenon related to chiral compounds, wherein the compounds may crystallize into different crystal structures or crystal forms under different conditions and/or processes. Specifically for pharmaceuticals, polymorphic forms of drug substances ‘exist in different crystalline forms which differ in their physical properties’. These property differences may result in direct medical implications, such as ease of formulation, increased efficacy, and reduced side effects. For example, the widely used analgesic drug, acetaminophen has three polymorphic forms, I, II, and III, among which only Form I is made into commercial dosage forms as the other two forms are either meta-stable or unstable. Nonetheless, uncovering an optimal crystal form is NOT an easy or straightforward task, because there are so many variables and possibilities involved, and chance of success lies heavily on the researcher’s experience and insights into the compounds in question. Both Anavex 2-73 (blarcamesine) and Anavex 19-144 have the potential to form different crystal forms. Through its deep understanding and abundance experience with these two compounds, Anavex was successful in discovering crystal forms of Anavex 2-73 (blarcamesine) and Anavex 19-144 that have advantageous physiochemical and/or pharmacological properties.

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