Melinta Therapeutics Initiates Phase 3 Registration Study of Delafloxacin in Individuals with Uncomplicated Gonorrhea

NEW HAVEN, Conn., January 9, 2014 – Melinta Therapeutics today announced the initiation of a Phase 3 trial of delafloxacin, a novel investigational fluoroquinolone, for the treatment of uncomplicated gonorrhea. The Phase 3 PROCEEDING (Prove Clinical Efficacy and Effectiveness of Delafloxacin in Neisseria Gonorrhoeae) program will assess the efficacy and safety of a single oral dose of delafloxacin  compared to ceftriaxone (given in a single intramuscular injection). Delafloxacin was designated a Qualified Infectious Disease Product (QIDP) by the FDA in this indication, as well as for ABSSSI. If approved for these indications, delafloxacin would receive an additional five years of extended market exclusivity (for a total of ten years), as provided for by the Generating Antibiotic Incentives Now (GAIN) Act of 2012.

“Due to the development of drug resistance, there is currently only one recommended treatment for gonorrhea, earning it a place on the CDC’s list of ‘urgent threats,'”1 stated Dr. Eugene Sun, executive vice president, research and development of Melinta. “Delafloxacin has demonstrated promising in vitro activity against Neisseria gonorrhoeae, including strains resistant to fluoroquinolones, and we therefore believe delafloxacin has the potential to help address the growing health crisis of resistant gonorrhea infections. The convenience of an oral preparation provides an additional tool for health care and public health community to treat gonorrhea and control its transmission.”

Gonorrhea is a sexually transmitted infectious disease caused by the bacterium N. gonorrhoeae that predominantly affects young men and women aged 15-24. Left untreated, gonorrhea can cause serious health problems, such as chronic pelvic pain, life-threatening ectopic pregnancy and infertility. Gonorrhea infection also increases a person’s risk of contracting and transmitting HIV.2 Over the history of antibiotics, N. gonorrhoeae has become resistant to each available class of drugs, including most cephalosporins and quinolones, leading the Centers for Disease Control and Prevention (CDC) to reduce the list of recommended antibiotic treatments to one: the combination of ceftriaxone + azithromycin.3 Without the development of new antibiotics, the CDC previously estimated the potential for a four-fold increase in gonorrhea, which could amount to 2.4 million infections and a direct lifetime medical cost of $780 million.4

“Due to the rise of drug-resistant gonorrhea, we are currently on our last drug to treat this disease and if no new antibiotics become available, untreatable gonorrhea has the potential to become a very serious epidemic,” stated William Smith, executive director of the National Coalition of STD Directors. “The current STD public health infrastructure has been continually strained by budget reductions both at the federal and states level and is currently unable to prepare as necessary for the arrival of untreatable gonorrhea.  An additional drug in the pipeline is a vital tool for STD public health programs in the arsenal in the fight against drug-resistant gonorrhea.”

Mary Szela, chief executive officer of Melinta Therapeutics, added, “By advancing delafloxacin into Phase 3 development for gonorrhea, we are one step closer to achieving our mission to commercialize groundbreaking antibiotics to overcome drug-resistant, life-threatening infections.”

Senator Richard Blumenthal, lead sponsor of the GAIN Act noted, “The GAIN Act, which I introduced in 2012, is already proving to be an important tool in encouraging the development of essential treatments and I’m pleased that Melinta, a Connecticut biotech company, is at the forefront of developing those treatments. I will continue to work to ensure that we put in place policies that prioritize the approval process for therapies that address the global health crisis of antibiotic resistance.”

About Delafloxacin

Delafloxacin, a novel fluoroquinolone, is also being tested in a Phase 3 clinical trial as an experimental treatment for acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive (including MRSA) and Gram-negative bacteria. For this indication, it was also awarded QIDP status by the FDA.

About Melinta Therapeutics

Melinta Therapeutics, based on the application of Nobel Prize-winning science, is dedicated to the discovery, development and commercialization of groundbreaking antibiotics to overcome drug-resistant, life-threatening infections. The need for new therapies for drug-resistant infections is widely recognized as one of the most serious public health issues facing the world today. To meet this need, Melinta Therapeutics is rapidly progressing its late-stage investigational antibiotic, delafloxacin, which is currently in Phase 3 development for acute bacterial skin and skin structure infections (ABSSSI) and uncomplicated gonorrhea. A key initiative at Melinta is to develop a new class of antibiotics designed to overcome the drug-resistant ESKAPE pathogens known to cause serious hospital infections. Melinta Therapeutics is privately held and backed by Vatera Healthcare Partners. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL.

For more information, visit www.melinta.com.

 

Footnotes

1) CDC. (September 2013) Antibiotic resistance threats in the United States, 2013. Atlanta: U.S Retrieved from http://www.cdc.gov/drugresistance/threat-report-2013/ [Accessed 12/10/2013]

2) CDC. (December 2012) Sexually Transmitted Disease Surveillance 2011. Atlanta: U.S. Retrieved from http://www.cdc.gov/std/stats11/surv2011.pdf

3) CDC. (August 2012) Update to CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2010: Oral Cephalosporins No Longer a Recommended Treatment for Gonococcal Infections. MMWR. Morbidity and Mortality Weekly Reports, 61(31);590-594. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a3.htm [Accessed 12/10/2013]

4) Bolan, G. (2012). Responding to the Urgent Threat of Antibiotic-Resistant Gonorrhea [PowerPoint slides]. Retrieved from NCSDDC website: http://www.ncsddc.org/sites/default/files/docs/final_presentation_dr._gail_bolan.pdf [Accessed 12/11/2013]