On April 29th at the Yale School of Medicine’s Anlyan Center, CURE BioHaven Entrepreneur Series presented “Melinta Therapeutics: The Road from the Lab to New Medicines”.

As one of the co-founding scientists, Dr. Thomas Steitz spoke about the scientific side of Melinta (formerly known as Rib-X Pharmaceuticals). Dr. Steitz is the Sterling Professor of Molecular Biophysics and Biochemistry and a Howard Hughes Medical Institute Investigator at Yale University. He was awarded the Nobel Prize in Chemistry in 2009 for studies of the structure and function of the ribosome, a molecular machine that translates genetic information encoded in DNA into proteins that carry out life functions. Comprised of a small (30S) and a large (50S) subunit, ribosomes are essential for all life forms including bacteria. Melinta’s scientific platform is based on the high definition X-ray crystallography modeling of the ribosome structure. The discovery of the elaborate structure of this molecular factory has tremendous therapeutic significance because it sheds light on how exactly antibiotics interact with the bacterial ribosome. With this Nobel Prize winning knowledge, Melinta designs and develops novel antibiotics that target the binding sites in the bacterial ribosome 50S subunit and kill the bacteria by inhibiting protein synthesis.

The first global report on antibiotic resistance released by the World Health Organization (WHO) on April 30th this year reveals the world is heading for a post-antibiotic era when bacteria change so antibiotics no longer work in the infected people. To tackle this worldwide public health threat, the WHO is calling attention to the need of new diagnostics and antibiotics. Policymakers and industry leaders are urged to promote innovation, research and development of new tools to fight the “Battle of Bugs”. Melinta has generated a pipeline of antibiotic drug candidates that offer new hope to overcome this urgent global health problem. Melinta’s lead product candidate, delafloxacin is undergoing clinical Phase 3 PROCEED trial for patients with acute bacterial skin and skin structure infections and uncomplicated gonorrhea. As part of this clinical study, an oral formulation of delafloxacin is administered which would potentially replace the current I.V. treatment model and significantly cut the cost of health care. Melinta plans to advance delafloxacin into clinical studies for other diseases such as hospital-acquired bacterial pneumonia, complicated urinary tract infections, and complicated intro-abdominal infections. Delafloxacin is among the first to receive Qualified Infectious Disease Product (QIDP) designation from the FDA under the new Generating Antibiotic Incentives Now (GAIN) Act. This designation will benefit Melinta with certain incentives for the development of new antibiotics including an additional five years of market exclusivity, priority review and eligibility for fast-tract status.

In the past decade, the pharmaceutical market has shifted and new players have emerged. R&D, the lifeblood of future products, has been perceived as high risk, and therefore has received less investment within big pharma companies. As a result, new products in the pipeline are limited, generics are becoming prevalent and profit margins are diminishing. This is bad news for patients and health care providers, especially in the field of antibiotics development because new drugs are not catching up with the bacteria evolution. Melinta enters the game in a great time when the unmet need is significant and the competition is minimal. Investors could expect to benefit greatly from market game changers such as Melinta.

In every challenge there lies opportunity. Conversely, wherever opportunity arises challenge follows. Eugene Sun, Senior Vice President of R&D at Melinta, talked about many roadblocks in the process of transforming a great scientific idea into a mature product. However, Mary Szela, CEO of Melinta, stressed the importance of believing in the value of true life-saving innovation. Susan Froshauer, former CEO of Melinta, also shared inspiring stories from the initial launch of Rib-X with its core scientific groundwork to the launch of Phase 3 trials of delafloxacin. Based on the solid scientific foundation and under the leadership of a strong management team, Melinta is pressing on to a bright future.

By Shannon Rao,
Business Development Assistant, CURE