The discovery of antibiotics in the first half of the 20th century reduced the mortality from infectious diseases in the developed world by 95%, and by the 1970s it was widely believed that bacterial diseases had been conquered. That prediction was overly optimistic; the infectious disease mortality rate jumped by 75% in the period 1980 – 1995, largely due to antibiotic resistance.  About 2 million people acquire bacterial infections in U.S. hospitals each year, and 90,000 die as a result.  About 70% of those infections are resistant to at least one of the major classes of antibiotics.   Despite increased resistance to antibiotics, the development of new antibiotics has slowed to a crawl and only two new antibiotics with novel mechanisms of action have been approved since 1998.

It has recently been demonstrated that many antibiotics act through the final common pathway of damage to bacterial DNA.  The bacterial protein RecA plays a central role in DNA repair and it is well established that RecA mediates the abilities of bacteria such as E. coli, P. aeruginosa, and S. aureus to overcome the metabolic stress induced by all bactericidal agents.

Synereca’s scientific founder, Professor Scott Singleton, and his colleagues have developed assays and reagents for the high-volume screening of chemical libraries for inhibitors of RecA.  A recent screen of 33,600 compounds yielded five separate chemical classes of RecA inhibitors.  Singleton furthermore demonstrated that combining a prototypic RecA inhibitor with the following antibiotics potentiates bacterial killing: ciprofloxacin, ampicillin, kanamycin, chloramphenicol, and mitomycin C.

Synereca is a spin-out of Dr. Singleton’s RecA inhibitor program originating at the UNC Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill.  Dr. Singleton serves as President and Chief Scientific Officer while maintaining his position at UNC.  Additional co-founders are W. Bennett Love, Vice President, Business Operations; Stephen B. Bocckino, Ph.D., Vice President, Preclinical Operations; and Clayton I. Duncan, who will serve as Chairman of the Board of Directors.  Each of the three co-founders has at least 15 years previous biotech/pharmaceutical experience and the co-founders have advanced spin out biotech/pharma projects from start up through venture funding, IPO (two) and/or acquisition (four) and have established and operated biotech/pharma collaborative partnerships (eight).  From the drug development perspective, the co-founders have previously advanced therapeutic compounds from molecule creation and early discovery through the various required preclinical tasks, successful filing of INDs and Phase 1, Phase 2 and Phase 3 clinical trials, including internationally.

The antibiotic market is segmented both by indication and by the antibiotic class.  The most common sites of infection are the lungs, skin, urinary tract, and there are more than 218 million of these infections in the US, Japan, and Europe annually.   Economic incentive exists as worldwide antibiotic revenues exceed $36 billion per year.  Synereca’s prototypic RecA inhibitor potentiates the effects of a fluoroquinolone (ciprofloxacin) and a penicillin (ampicillin), antibiotic classes with over $13 billion in global sales.

Commercial development of antibacterial drugs presents a significant opportunity to satisfy an unmet medical need.  The predictive accuracy of preclinical pharmacology and short clinical trials with clear endpoints make antibiotic drug development a favorable therapeutic area for early stage companies.