BioPharmX announced the U.S. Patent and Trademark Office has granted a patent in what the company expects will be a new family of patents protecting its novel topical gel delivery system that allows for greater bioavailability of an active pharmaceutical ingredient (API).
The patent (U.S. Patent No. 9,918,998), entitled "Pharmaceutical Tetracycline Composition for Dermatological Use," covers a topical composition comprised of minocycline or another tetracycline-class drug and a method for making such compositions. The patent also covers treatments of dermatological inflammation or infection using a minocycline composition. Current formulations protected by the patent include BPX-01 for the treatment of acne and BPX-04 for the treatment of rosacea.
This is the fourth U.S. patent issuance BioPharmX has received. Three earlier-issued U.S. patents protect the company's encapsulation delivery system, which can isolate the API. The most recent of these patents, U.S. Patent No. 9,901,586, entitled "Dosage Form Comprising an Active Ingredient and a Plurality of Solid Porous Microcarriers," was granted Feb. 27.
The US 9,918,998 patent protects tetracycline-class products carried by BioPharmX's innovative delivery system, which for the first time stabilizes and fully solubilizes these drugs to make them effective in a topical formulation. This includes products that use other tetracycline-class drugs as well as combination products that combine antibiotics with other drugs, for example retinoids.
"This patent protection is a significant milestone for BioPharmX," said President and Co-founder Anja Krammer. "It recognizes that our development of a topical tetracycline-class drug, something that has eluded the pharmaceutical industry since minocycline was first commercially used in the 1970s, is truly unique."
BioPharmX has successfully completed a phase 2b trial for BPX-01 for acne and is in phase 3 readiness. The company has reported positive interim results from a feasibility study for BPX-04 for rosacea and is preparing for a phase 2 trial.
BPX-011 and BPX-041 are hydrophilic (non-oil-based) topical gels with fully solubilized minocycline that have been shown to penetrate the skin to deliver the antibiotic to its target. Following positive results from its previously announced phase 2b dose-ranging study of BPX-01 in acne, BioPharmX continues with phase 3 clinical study plans for BPX-01 for the treatment of inflammatory lesions of acne.