ContraFect to Present CF-301 Phase 1 Trial Data at the 26th ECCMID Conference
YONKERS, NY -- (Marketwired) -- 03/29/16 -- ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW), a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that it will present new clinical data from a Phase 1 clinical trial of CF-301 at the 26th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) to be held on April 9-12, 2016 in Amsterdam.
"This is an exciting time for ContraFect as well as the lysin field, as we have successfully concluded the first in human trial of CF-301, a first in class lysin drug candidate," said Steven C. Gilman, PhD, Chairman and CEO of ContraFect. "We are now expeditiously moving towards the next phase of development of CF-301, which will be in patients with Staph aureus bacteremia."
"We are pleased that CF-301 was generally well tolerated and that there were no clinical adverse safety signals identified in this Phase 1 study. Pharmacokinetic (PK) parameters were linear across the 4 doses tested," said Cara Cassino, M.D., Chief Medical Officer of ContraFect. "Staph aureus infections continue to result in substantial morbidity and mortality despite available therapies. CF-301 in combination with conventional standard of care antibiotics has the potential to improve clinical outcomes in patients with Staph aureus infections."
This CF-301 Phase 1 study was a single-center, double-blind, randomized, placebo-controlled, escalating, single-dose study in healthy male and female subjects. CF-301 or placebo were administered via 2-hour IV infusion at 4 CF-301 dose levels: 0.04, 0.12, 0.25, and 0.4 mg/kg/dose. Subjects remained in the clinic from days -1 to 4. Serial blood and urine samples were collected for clinical laboratory tests and PK. Safety assessments included physical exams, vital signs, 12-lead EKGs, Holter monitoring/telemetry, and adverse events (AE). Subjects returned on days 5, 8, 14 and 28 for follow-up safety evaluation. All subjects were tested for anti-drug antibodies (ADA), immunoglobulin E (IgE), and ex vivo basophil activation (BAT) on Days -1, 5, 8, 14 and 28 and at ongoing long-term follow-up visits (days 90 and 180). Subjects with pre-existing positive readings for any of these tests during screening were excluded from the trial. An independent Data Safety Monitoring Board (DSMB) reviewed unblinded safety and PK data at pre-specified points throughout the study.
Subjects were dosed at each of the 4 planned dose levels, for a total of 20 subjects. There were no serious AEs, and no study stopping rules were met. In addition, no hypersensitivity AEs related to CF-301 were observed. A total of 5 non-serious AEs were reporting during the study. Two subjects who received CF-301 reported a total of three non-serious AEs (headache, contact dermatitis, and allergic rhinitis). Two subjects who received placebo reported a total of two non-serious AEs (viral upper respiratory tract infection and viral infection). All of these events were mild in intensity and resolved. No patients withdrew from the study for an adverse event. At the 0.25 mg/kg dose, the geometric mean (gMean) CF-301 AUC(inf) was 1,758 hr x ng/mL, and the gMean Cmax was 731 ng/mL. Exposure was dose dependent and intra-subject variability was low. Estimated effective exposure, based on animal models of Staph aureus infections, was attained at the 0.25mg/kg dose.
The abstract on this data can be found on the ECCMID website (http://www.eccmid.org/). ContraFect's presentation information is as follows:
Abstract Title: Results of the First-in-Human Study of Lysin CF-301 Evaluating the Safety, Tolerability, and Pharmacokinetic (PK) Profile in Healthy Human Volunteers
Session Title: Late breaker ePoster
Session Day and Time: April 9, 2016, 8:45-15:30 CET
Abstract #: EVLB62
CF-301 is a recombinant bacteriophage-derived lysin with potent, bactericidal, activity against Staphylococcus aureus (Staph aureus), a major cause of blood stream infections, or bacteremia. CF-301 has the potential to be a first-in-class treatment for Staph aureus bacteremia as it has a novel, rapid and specific mechanism of bactericidal action against Staph aureus and does not impact the body's natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. Combinations of CF-301 with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or CF-301 alone. In addition, in vitro and in vivo experiments have shown that CF-301 is highly active against biofilm infections. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect.
ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect's initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant Staph aureus bacteria) and influenza.
This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "new", "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipate," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding the presentation of our Phase 1 clinical trial data, our ability to move towards our next phase of CF-301 development, the ability of CF-301 in combination with conventional standard of care antibiotics to provide improved clinical outcomes in patients with Staph aureus infections, our CF-301 Phase 1 study results, the potential for CF-301 to be a first in class treatment for Staph aureus and ContraFect's ability to discover and develop therapeutic protein and antibody products for life-threatening, drug resistant infectious diseases. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including those detailed in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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Source: ContraFect Corporation
Released March 29, 2016