PolyMedix Presents New Data on Its Defensin-Mimetic Antibiotics at 52nd Annual ICAAC
Presentations Include Additional Analysis of Brilacidin Phase 2 Clinical Data
RADNOR, Pa., Sept. 11, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative approaches to transforming the treatment of infectious diseases, today announced that the Company presented data on its defensin-mimetic antimicrobial compounds at the 52nd Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, CA. The presentations included results of the first Phase 2 clinical study of PolyMedix's lead defensin-mimetic, brilacidin (PMX-30063), which showed high clinical response rates in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus.
"We are excited to present data at ICAAC from our first Phase 2 study with brilacidin and our preclinical studies with other defensin-mimetic compounds," said Dr. Richard Scott, Vice President of Research at PolyMedix. "We are proud to be the pioneers in developing defensin-mimetics, a novel class of antibiotics with a distinct mechanism of action from currently known drugs. We look forward to advancing the development of these innovative compounds and exploring their potential to treat a wide range of infectious diseases."
In a multicenter, double-blind dose-ranging Phase 2 study, 215 patients with ABSSSI (Acute Bacterial Skin and Skin Structure Infections) and evidence of Staph aureus were randomized into three treatment groups and given a low (0.40 mg/kg day 1 + 0.30 mg/kg days 2-5), medium (0.75 mg/kg day 1 + 0.35 mg/kg days 2-5) or high (1.0 mg/kg day 1 + 0.35 mg/kg days 2-5) dose of brilacidin for 5 days followed by 2 days of placebo, or daptomycin for 7 days. Investigators examined response rates at days 2-3, 7-8, 10-14 and 28. A patient met the response criteria if there was a significant reduction in lesion size at all four assessment visits. As indicated in the table below, the results of this study showed that clinical response rates were high across all treatment groups and similar to daptomycin:
Low dose n=40
Medium dose n=35
High dose n=39
Data based on per protocol patient population.
In the study, brilacidin was safely administered and adverse events appeared to be exposure-related. Aside from mild, transient numbness and tingling, for which no patient discontinued treatment, the overall adverse event rates were under 10% in each dose group. Rare cases of transient systolic blood pressure elevations occurred in 6 of the 160 (3.8%) patients treated with brilacidin. Of the six patients, three were in the high dose group. The one patient in the low dose group that experienced high blood pressure was reported as having pre-existing hypertension.
PolyMedix scientists believe that the attributes of brilacidin, including rapid bactericidal action, efficacy driven by exposure and not time, long half-life, and a long post-antibiotic effect, support exploring shorter courses of treatment in future clinical studies.
"We are very encouraged by the results of the Phase 2 study for this new class of antibiotics, and believe the continued analyses support the further development of this compound," commented Dr. Daniel Jorgensen, Senior Vice President of Clinical Development and Chief Medical Officer at PolyMedix. "There are many aspects to brilacidin which we believe will distinguish it from other antibiotics, most particularly, its low potential for the development of bacterial resistance, as observed in our preclinical studies. Resistant bacterial infections are a growing medical problem in need of novel solutions. We are looking forward to advancing the clinical development of brilacidin and exploring shorter courses of therapy in our Phase 2B clinical trial."
Additional data presented by PolyMedix at ICAAC included:
In preclinical studies, HDP mimics were shown to have potent and rapid bactericidal activity against some of the most prevalent foodborne pathogens, including E. coli and Campylobacter species, among the most common causes of foodborne disease, bacterial diarrheal illness, and deaths. 30 HDP mimics, from 6 structural series, were broadly active against at least 6 of the 8 foodborne pathogens screened and many of the compounds (26) showed low cytotoxicity against mammalian cells. Animal studies are underway to identify lead compounds for the treatment of foodborne illnesses.
Compounds that mimic the activity of HDPs were found to be active against Gram-positive and Gram-negative biofilm cultures, with low cytotoxicity. Their effectiveness supports further evaluation of these and other HDP mimics as therapeutic agents for treatment of biofilm-associated infections.
Brilacidin (PMX-30063) exhibited potent activity against multi-drug resistant S. aureus and coagulase-negative staphylococci and six isogenic strain pairs of daptomycin-sensitive and resistant MSSA and MRSA, demonstrating brilacidin is highly active in vitro against multi-drug resistant staphylococci.
PolyMedix is a clinical stage biotechnology company dedicated to transforming the treatment of infectious diseases. PolyMedix is developing a new class of antibiotics – defensin-mimetics – for the treatment of serious, life-threatening infections which often develop resistance to currently available antibiotics. PolyMedix's compounds are designed to imitate the mechanism of action of host defense proteins, which contribute to natural human immunity. In contrast to existing antibiotics, brilacidin was designed to exploit a method of bacterial cell killing, via biophysical membrane attack, against which bacteria have not shown development of resistance in multiple preclinical studies. Brilacidin (formerly PMX-30063), our lead antibiotic compound, showed efficacy similar to an active control, and was safely administered in a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staphaureus bacteria (including methicillin-resistant Staphylococcus aureus (MRSA)). PolyMedix is planning to initiate a Phase 2B dose optimization study with brilacidin in ABSSSI patients. PolyMedix is also developing brilacidin as a topical treatment for oral mucositis, a common and often debilitating complication of cancer treatments.
PolyMedix has internally developed an extensive pipeline of compounds including other defensin-mimetic antimicrobial compounds for other infectious diseases such as Gram-negative pathogens, fungal infections, and malaria; PolyCides®, antimicrobial additives to materials to create self-sterilizing products and surfaces; and delparantag (formerly PMX-60056), an anticoagulant reversing agent. PolyMedix's compounds have been internally discovered using a proprietary drug design technology.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix's need for, and the availability of, substantial capital to fund its operations, planned clinical trials and research and development, and the fact that PolyMedix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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