Biopharma firm Trius Therapeutics, Inc. (NASDAQ:TSRX) which focuses on developing innovative antibiotics for serious infections, and whose lead investigational drug is tedizolid phosphate announced that the U.S. Food and Drug Administration (FDA) has designated the company's Phase 3 antibiotic candidate, tedizolid phosphate, as a Qualified Infectious Disease Product (QIDP). Tedizolid phosphate is a once daily, IV and orally administered second generation oxazolidinone in Phase 3 clinical development for the treatment of serious gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
The FDA Trius designation (both the intravenous and oral dosage forms of tedizolid) is for the company's current Phase 3 program of tedizolid for acute bacterial skin and skin structure infections (ABSSSI). The designation is also for the planned Phase 3 program for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).
The FDA, QIDP designation benefits Trius is multiple ways and should be looked as another chain in the link completed to commercialization of the product. The designation will enable Trius to benefit from incentives for the development of new antibiotics. These include priority review and eligibility for fast-track status, significant in an industry where development can involve a 10 year span in some instances.
A QIDP designation is rooted in the FDA's GAIN act (Generating Antibiotic Incentives Now) which exists for the promotion of quicker antibiotic development, and has benefited multiple drug development efforts since its inception.
Progress noted on Tedizolid Phosphate
ESTABLISH 2 Trial
The company's ESTABLISH 2 second ABSSSI Phase 3 trial has completed enrollment. The trial is to examine the efficacy and safety of a six-day course of tedizolid administered once a day versus a 10-day course of linezolid (Zyvox®) administered twice a day in patients. Sites include North and South America, Europe, Australia, New Zealand and South Africa. For both tedizolid and linezolid, drug was initially administered as an intravenous (IV) infusion with the option to switch to oral therapy.
ESTABLISH 1 Trial
The ESTABLISH 1 trial, tested the oral dosage form of tedizolid and met all requirements for FDA and European Medicines Agency (EMA) primary and secondary efficacy. This was established in September of 201. The outcomes and demonstrated significantly lower safety and tolerability events compared to linezolid.
A preliminary, unaudited financial from the company indicates that as of December 31, 2012, the company had cash, cash equivalents and investments totaling $66.0 million.
Trius, currently trading at $5.25 with a 52 Week Range of $4.41 - $6.78, has partnered with Bayer HealthCare for the development and commercialization of tedizolid phosphate outside of the U.S., Canada and the European Union.