PolyMedix, Inc ($PYMX) announces topline results from phase 2 study evaluating PMX-30063

PolyMedix (OTCBB: PYMX) announced topline results from a Phase 2 proof-of-concept study evaluating PMX-30063, a first-in-class investigational antibiotic, for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph aureus.

• The study objectives were met, demonstrating clinical efficacy and safety in all evaluated doses of PMX-30063.
• In the study, patients were first evaluated at day 3 for clinical response using FDA's most recent ABSSSI Guidance. Patients receiving low, medium, or high doses of PMX-30063 experienced high clinical response rates at Day 3.
• Clinical Response at Day 3
  • Per Protocol: Low Dose 85.0%; Medium Dose 71.4%; High Dose 89.7%; Daptomycin 74.5%
  • mITT: Low Dose 81.4%; Medium Dose 67.6%; High Dose 77.8%; Daptomycin 74.5%
  • ITT: Low Dose 79.6% Medium Dose 68.5%; High Dose 75.9%; Daptomycin 75.5%
• All regimens of PMX-30063 for all patient populations and time points showed early, high and sustained clinical responses. The 95% confidence intervals for the day 7, 10 and 28 assessments illustrate the consistency of clinical responses for all dosing arms of PMX-30063 compared to active control.
• In the study, PMX-30063 appeared to be safe and was generally well-tolerated. As expected and consistent with previous clinical studies, patients receiving PMX-30063 commonly reported sensations of numbness and tingling that were generally characterized as mild and resolved following treatment. No patient stopped treatment as a result of these sensations. Other treatment-related adverse event rates were similar across all treatment arms.
• There was one treatment-related serious adverse event that was at least possibly drug-related reported in each PMX-30063 study arm. Treatment-related serious adverse events included an instance of hypertension in the medium and high dose regimens, which discontinued therapy, and an instance of increased platelets in the low dose regimen.
• As previously announced, PolyMedix plans to discuss the results of this PMX-30063 Phase 2 clinical trial on its conference call to be held today at 9:00 am Eastern Time and to present study details, including microbiologic data, at a future medical meeting(see linked comment).

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PolyMedix ($PYMX) - Cowen Research Report is released

PolyMedix (PYMX) -- Outperform (1)

PYMX files 10K; focus remains on antibiotic & heptagonist data expected 1H12

Summary: PolyMedix filed its 2011 10K last night, reporting 4Q11/FY11 numbers. There were no significant updates in the 10K, other than the financials, and investors' attention remains focused on the PMX-30063 (antibiotic) and PMX-60056 (heptagonist) Phase II data expected in 1H12.

• Antibiotic data, expected in a few weeks, represent the moment of truth for PYMX. We believe that the full data from PMX-30063's trial in ABSSSI, which will include data from MRSA patients, will be a very significant milestone for PYMX shares, since it will represent the first time that one of the company's compounds will have been tested in 1) a relatively large 2) patient population. If the full Phase II data replicate what we saw in the first ~80 patients, especially if the drug continues to demonstrate 1) very high clinical response rates, averaging 92% among the four groups, and 2) a clean safety profile, we expect the market to start paying much closer attention to PYMX. Given the compound's first-in-class status, coupled with its mechanism of action, that carries the theoretical potential to overcome resistance, we believe that if the full Phase II data corroborate what we saw in the interim look, investors will start viewing PMX-30063 as a compound with significant commercial potential.
• Data from two PMX-60056 trials expected in 1H12. In addition to PMX-30063, investors will be watching for data from: 1) the 40-patient Phase II trial of PMX-60056 in PCI (Percutaneous Coronary Intervention), and 2) the Phase Ib/II dose-ranging trial of PMX-60056 in the reversal of Lovenox.
• 4Q11/FY11 numbers reported. PYMX spent $6.7M ($4.9M in R&D, $1.9M in SG&A) in 4Q11 and $21M ($13.8M in R&D, $7.2M in SG&A) in FY11, and ended 2011 with $14.6M in net cash ($21.4M in cash, minus $6.8M in debt).

Simos Simeonidis, Ph.D.
(646) 562-1386
simos.simeonidis@cowen.com

Yatin Suneja
(646) 562-1388
yatin.suneja@cowen.com

PolyMedix ($PYMX) Cowan Research

View more documents from ProActive Capital Resources Group.

FDA Declared Support for a New AntioBiotic Pathway - Positive for Companies like PolyMedix ($PYMX)

News from the FDA which declared its oprganizational support for a new pathway for review and approval of drugs to treat infections that are not susceptible to existing drugs said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. The new pathway was proposed by the Infectious Diseases Society of America in a statement submitted to the House Energy and Commerce Committee's health subcommittee. Under the proposal, products designated as "Special Population Limited Medical Use Drugs" could be studied in abbreviated clinical trials for specific populations, such as patients with drug-resistant infections, and measures would be taken to limit off-label use.

Speaking at a health subcommittee hearing Thursday, Woodcock also endorsed the goals of the Faster Access to Specialized Treatments (FAST) Act, which seeks to expand FDA's use of accelerated approvals. She said legislation instructing FDA to establish a new pathway for reviewing breakthrough drugs would be "helpful".

Daily Dose Conclusion: This news is positive for names like Polymedix (PYMX).

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