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Synthetic Biologics strengthens C. difficile program with new patents in Europe

US-based biotechnology firm Synthetic Biologics has secured new patents in Europe as well as a notice of allowance in Australia that provide composition of matter coverage for various aspects of its C. difficile (C. diff) program.

The company said that its extensive C. diff patent estate now includes more than 25 US and international patents.

Currently, the company is in preclinical development of SYN-004, a new second generation oral enzyme drug candidate.

The drug is indicated for co-administration with commonly used intravenous (IV) antibiotics intended to protect the gastrointestinal microflora (microbiome) from the effects of IV antibiotics for the prevention of C. diff infections.

C. diff infections are a leading cause of hospital acquired infections that generally occur secondary to treatment with IV antibiotics, which are administered to about 14.4 million patients in the US per year.

The company said that recent European patents EP1451292 and EP2038411 were validated in 16 major European nations and provide composition of matter coverage for strains that allow production of its oral enzymes and potential further candidate oral enzymes, respectively.

Furthermore, allowed Australian Patent Application 2011257092 includes claims to compositions and methods of using the company’s lead C. diff candidate, SYN-004.

Synthetic Biologics chief executive officer Jeffrey Riley said these new patents expand the company’s C. diff patent portfolio and strengthen its intellectual property position around its novel biologic candidate, SYN-004.

"Synthetic Biologics is developing SYN-004 to neutralize IV antibiotics in the gut, and is intended to protect and maintain the balance of bacterial flora in the GI tract, thereby preventing C. diff infection," Riley said.

"The granting of these patents is another key development in Synthetic Biologics’ plan to initiate Phase Ia and Ib C. diff clinical trials during the second half of 2014."