PolyMedix Reports Second Quarter 2012 Financial Results

RADNOR, Pa., Aug. 9, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced its financial results for the second quarter ended June 30, 2012 and provided an update on recent key events.

"During the second quarter we significantly advanced the development of our novel defensin-mimetic antibiotic brilacidin, with positive results from our Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI)," commented Nicholas Landekic, President and Chief Executive Officer of PolyMedix. "Our goal is to become a leader in the antibiotic market, by developing novel defensin-mimetics which are intended to directly address the growing problem of bacterial drug resistance. These efforts are spearheaded by our lead infectious disease drug candidate, brilacidin, which has shown encouraging clinical results which we believe will support more advanced clinical development."    

Business Update:

Brilacidin (formerly PMX-30063) in patients with ABSSSI
  • PolyMedix recently completed and announced positive results from its Phase 2 clinical trial with brilacidin as an intravenous treatment in patients with ABSSSI. The trial enrolled 215 patients who were randomized to receive one of three doses of brilacidin or an active comparator, daptomycin. Brilacidin exhibited high clinical efficacy in all dose groups, at a level similar to daptomycin, and was safely administered.  
  • PolyMedix is planning to conduct a Phase 2B study with brilacidin in ABSSSI to examine both shorter courses of therapy and lower total amounts of drug than were used in the previous Phase 2 trial. The trial is expected to enroll approximately 100-200 patients. Based on analysis of clinical and preclinical data to date, PolyMedix believes brilacidin may be safe and effective when administered as a single dose or once daily for three days, courses of therapy that are shorter than the approved regimens for all marketed antibiotics indicated for ABSSSI.  PolyMedix's clinical team is in the process of conducting pharmacokinetic and pharmacodynamic analyses to determine final dosing regimens for this Phase 2B study.   
  • PolyMedix plans to discuss with the United States Food & Drug Administration (FDA) its clinical development plans for brilacidin. Pending the outcome of these discussions and availability of adequate cash resources, PolyMedix plans to initiate the Phase 2B study later this year with results expected in the first half of 2013.   
  • In the future, PolyMedix also intends to expand the potential indications and uses of brilacidin by leveraging the data obtained from its recent clinical study and extensive preclinical investigations. Accordingly, PolyMedix intends to utilize its intravenous formulation of brilacidin to conduct future proof-of-concept clinical studies in other infectious disease indications, such as blood stream and lung infections.

Brilacidin in Cancer Oral Mucositis
  • At the American Society of Clinical Oncology (ASCO) annual meeting in May, PolyMedix presented preclinical data from studies which showed encouraging efficacy in animal models of oral mucositis. Based on this work, PolyMedix believes brilacidin has significant potential for development as an oral rinse for treating oral mucositis in cancer patients, a common and often debilitating complication from radiation and chemotherapy treatment. PolyMedix is currently conducting preclinical studies, including additional animal toxicology studies, for its planned investigational new drug application (IND) filing with FDA. With regulatory approval and adequate additional funding, the Company expects to begin clinical trials in cancer patients in the first half of 2013. 

Defensin-mimetic Research
  • PolyMedix recently received a grant from the National Institutes of Health for up to $3 million of funding to develop defensin-mimetic antimicrobial compounds against malaria. This second phase of grant funding follows a successful first phase in which PolyMedix previously received $1 million of funding for anti-malaria research. This work is being conducted in collaboration with Dr. Doron Greenbaum at the University of Pennsylvania.

Previously, PolyMedix has received 15 grants and sponsored research contracts, from the National Institutes of Health, the National Science Foundation, the Defense Threat Reduction Agency, the United States Army, and the United States Navy. PolyMedix continues to strive to support the majority of its research costs through such grant and research contract funding. With this support, PolyMedix has to date created a library of approximately 1,600 defensin-mimetic antimicrobial compounds in multiple distinct chemical series, which are being evaluated for potential use in indications such as malaria, Gram-negative pathogens, food-borne pathogens, fungal pathogens, and for biodefense applications.

Financial Results

Unaudited financial information of PolyMedix at and for the quarter ended June 30, 2012 is included in the tables at the end of this press release. As of June 30, 2012, PolyMedix had cash, cash equivalents and investments totaling $12.3 million.