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Re: KMBJN post# 146676

Thursday, 05/05/2016 7:19:39 PM

Thursday, May 05, 2016 7:19:39 PM

Post# of 405194
From the discussion section.

"Because of the subcutaneous route of administration, doses higher than 3.0 mg/kg (which would have required larger injection volumes or additional injections) were avoided. Dose-proportional PK was observed after single doses. No clinically relevant changes in any inflammation biomarker were observed with anti?IL-20 compared with placebo. Furthermore, no evidence of clinical response was observed in patients with PsO after 7 weekly doses of 2 mg/kg anti?IL-20.

Histology measurements and evaluation of the responses were performed in a blinded manner. Findings from a single patient in the expansion phase treated with anti?IL-20 showed marked improvement in epidermal hyperplasia and acanthosis by week 15 (Fig 5). However, the histology analyses could not be used to provide definitive conclusions on exploratory PD endpoints because of the limited number of biopsy samples."

"This was primarily a trial designed to investigate the safety and tolerability of anti?IL-20 and, hence, several limitations of the current trial should be noted, which precluded definitive conclusions regarding clinical response. Most important were the small patient sample size (the cohort sizes were limited because the aim of the dose-escalating phases was not to demonstrate clinical efficacy), limited data (particularly for the histology analyses), and the premature discontinuation of the trial. In addition, a maximum tolerated dose was not reached, suggesting that an optimal dose and dose regimen were not achieved in this trial."

We are going to know one way or the other soon enough! I personally think the odds are in Prurisol's favor, but I am definitely biased!

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0134703

LEGEND OF ABBREVIATIONS
B = Brilacidin, the antibiotic
K = Kevetrin, the oncology drug
P = Prurisol, the psoriasis drug
SAE = Serious Adverse Event
IND = Investigational New Drug


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