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news.US-based biotechnology firm Heron Therapeutics has started a single-ascending dose, placebo-controlled Phase I clinical trial of HTX-011, which is currently being developed to treat post-operative pain.
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By using the company’s Biochronomer polymer-based drug delivery platform, HTX-011 releases the local anesthetic bupivacaine and the anti-inflammatory meloxicam over an extended period.
The Phase I trial in healthy volunteers is designed to evaluate safety, pharmacokinetics and pharmacodynamics of the anesthetic effects of HTX-011, which has already been shown to significantly reduce pain in a validated animal model for up to 72 hours following surgery.
Initial results from the Phase I trial of HTX-011 are expected to be reported before the end of the first quarter of 2015.
The company is also preparing for a series of Phase Ib/II trials of HTX-011 in several post-surgical pain settings, and expects to start the first of these trials in the second quarter, with data scheduled to be reported before the end of 2015.
The Biochronomer technology is designed to improve the therapeutic profile of injectable pharmaceuticals by extending the duration of action of known active ingredients.