On February 10, 2104 a substantial financial deal was announced by Melinta Therapeutics involving their projected blockbuster antibiotic Delafloxacin. A whopping 70 million dollar Series 3 equity financing deal was revealed, with various investors taking part, including Vatera Healthcare Partners. This extraordinary financing will be appropriated largely to advance the continued development, assessment and eventual marketing of the novel fluoroquinolone Delafloxacin. A Phase 3 study is the focus of efficacy for this differentiated fluoroquinolone for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive (MRSA) and Gram-negative bacteria. Delafloxacin is administered via an intravenous infusion as of now, but testing models are leading toward a hopeful oral dosage which would be an effective “step down” treatment for patients. A submission for an NDA is also expected from Melinta in late 2014 for the use of Delafloxacin as one time oral dose to treat uncomplicated gonorrhea.
Clinical studies have demonstrated a comprehensive ability of Delafloxacin to combat a vast array of infections, including those that are resistant to quinolone-resistant S. aureus (QRSA) and methicillin resistant S. aureus (MRSA). When compared to the powerful antibiotic Vancomycin in a Phase 2 trial Delafloxacin met the primary endpoint of a cure assessment, and proved to be an equally effectual antibiotic. Adverse effects from Delafloxacin are generally mild, and study participants have complained mainly of nausea, vomiting and diarrhea. Plans from Melinta to assess the use of Delafloxacin for fighting other serious infections, particularly those that are drug resistant, include clinical studies to combat complicated urinary tract infections, hospital-acquired bacterial pneumonia and complicated intra-abdominal infections.
The unique ability of Delafloxacin to be a first-line antibiotic in hospital setting prior to a specific diagnosis makes this new antibiotic a boon for broad spectrum efficacy. The strong Gram-positive potency, as well as the cogent in vitro activity against Gram-negative bacteria makes Delafloxacin a pharmaceutical triumph. Data from over 1,400 patients has offered a well-tolerated experience for those participants who were administered Delafloxacin, and when compared to Linezolid (Zyvox) Delafloxacin proved to be the better antibiotic option. Studies in 2011 that compared both Delafloxacin and Linezolid with and without the addition of Astreonam and Vancomycin revealed statistical superiority for Delafloxacin. This data was gathered in patients with ABSSSI, and Delafloxacin offered exceptional efficacy for reducing fever and ceasing the spread of infectious skin lesions faster than any of the pharmaceutical treatment comparisons.
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