Paratek Pharmaceuticals, Inc. Wins Agreement With FDA on Special Protocol Assessment (SPA) for Phase 3 Study in Community-Acquired Bacterial Pneumonia (CABP)
3/28/2012 7:31:15 AM
BOSTON, March 28, 2012 /PRNewswire/ -- Paratek Pharmaceuticals, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on its second Special Protocol Assessment (SPA) related to the Phase 3 program design for the Company's lead antibiotic candidate, omadacycline (formerly PTK 0796). Omadacycline is a broad-spectrum, first-in-class aminomethylcycline antibiotic with oral and IV formulations that Paratek is developing to address the leading organisms that cause bacterial infections such as serious (acute) bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), including those caused by resistant bacteria.
The SPA is an FDA-defined process under which Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim, are agreed upon with the Agency in a manner which binds the FDA not to alter its perspective on the issues of design, execution, or analyses. Paratek has now come to agreement with the FDA through the SPA process for trials expected to support approval for treatment of both ABSSSI and CABP, bacterial indications with significant medical need. The trial designs agreed upon through both SPAs are double-blind, randomized and controlled and will compare omadacycline to the standard of care therapies. Paratek's SPAs in ABSSSI and CABP both accommodate the FDA's new directives on early response endpoints and allow oral and IV treatment to be used in a range of patients seeking treatment for serious skin and community-acquired pneumonia infections.
"This is the first SPA agreement for CABP under the FDA's new early response endpoint that we are aware of, and we believe that it clarifies the regulatory path to approval and supports the appropriateness of omadacycline for these two important infections (ABSSSI and CABP)," said Chief Medical Officer, Dr. Gary J. Noel. Dr. Noel joined Paratek in 2010 to lead the omadacycline development program into registration studies that could support approval. Dr. Noel brings with him 30 years of infectious disease clinical and drug development experience, most recently at Johnson & Johnson where he was the Franchise Medical Leader in anti-infectives with responsibilities for the clinical development of Levaquin (levofloxacin), Zeftera (ceftobiprole) and Doribax (doripenem).
Paratek also announced today that omadacycline will be the subject of several poster presentations at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held in London from March 31-April 3, 2012. Data supporting the clinical safety and efficacy of omadacycline in serious skin infections (P-694) are being presented on Saturday, March 31, 3:30-4:30 p.m. Additional preclinical data supporting the metabolic stability, lack of interactions with human transporter, bioequivalence, safety and tolerability of multiple formulations of omadacycline in healthy subjects, and the antimicrobial activity against bacteria collected in European community and hospital respiratory tract infections are being presented on Sunday, April 1, 1:30-2:30 p.m. (P-1422-1424 and P-1449-1450).
Copies of these posters will be available on the Paratek website following the ECCMID meeting http://www.paratekpharm.com.
About Paratek Pharmaceuticals
Paratek Pharmaceuticals, Inc. is engaged in the discovery and commercialization of new therapeutics that treat serious and life-threatening diseases, with a particular focus on the growing worldwide problem of antibiotic resistance. Paratek is advancing novel compounds that can circumvent or block bacterial resistance. Paratek's lead compound, omadacycline (formerly PTK 0796), is a broad-spectrum (gram-positive, gram-negative, atypical and anaerobic coverage) first-in-class aminomethylcycline antibiotic with oral and IV formulations. Omadacycline is being developed for the treatment of the most common and serious bacterial infections such as ABSSSI and CABP, including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings. Omadacycline has been tested in more than 500 healthy subjects, and oral and IV formulations of omadacycline have been compared to Zyvox ® in Phase 2 and Phase 3 clinical studies in more than 350 patients with complicated skin and skin structure infections (cSSSI).
Paratek has an active chemical synthesis effort to produce novel and diverse small molecule tetracycline derivatives, with the goal of developing nonantibacterial compounds with improved activity in serious inflammatory and neurodegenerative diseases including Multiple Sclerosis (MS). In addition, Paratek is developing distinct tetracycline derivatives that specifically modify mRNA splicing, with therapeutic potential in spinal muscular atrophy (SMA).
Paratek has active collaborations with Warner-Chilcott and NIH to develop tetracycline-derived small molecule drugs for acne & rosacea and SMA, respectively. Paratek is privately held and headquartered in Boston, Massachusetts, USA. For more information, visit Paratek's website at http://www.paratekpharm.com.
CONTACT: Kathryn M. Boxmeyer, Vice President & CFO, Paratek Pharmaceuticals, Inc., +1-617-275-0040 ext. 238, firstname.lastname@example.org
SOURCE Paratek Pharmaceuticals, Inc.