Mar 18 2008
NanoBio Corporation reported top-level findings today from its phase 2b study of NB-001, a topical lotion to treat herpes labialis (cold sores). The randomized, double-blind, vehicle- controlled study met its primary and secondary endpoints by demonstrating clear efficacy and safety in 482 patients.
NanoBio's uniquely formulated lotion resulted in faster healing of cold sores, at a rate never seen before by a topical product. The company's targeted phase 3 dose demonstrated highly statistically significant clinical efficacy in phase 2b at a magnitude comparable with or superior to what has been reported for the leading oral (systemic) anti-herpetic drugs on the market today.
Additionally, NB-001 demonstrated an excellent safety profile, with no serious adverse events, significant skin irritation or systemic blood absorption. In contrast, leading oral systemic treatments for herpes labialis carry label warnings that include nausea, diarrhea, vomiting, rash and migraine.
"Through this trial, we have confirmed that NB-001 achieves the efficacy of leading systemic treatments without presenting safety, drug interaction or toxicity risks," said James R. Baker Jr., MD, founder and chairman of NanoBio Corporation. "Based on the data, NanoBio will move immediately to initiate plans to begin phase 3 testing of NB-001 in early 2009." The full data set from the phase 2b study will be presented following a standard peer review process.
NB-001 is a proprietary oil-in-water emulsion composed of nanometer-sized droplets that employ a physical process to disrupt the outer lipid membrane of viruses. The droplets traverse the pores and hair follicles of the skin without disrupting normal tissues. These droplets accumulate in the epidermis and dermis where they interact directly with and kill the viral organisms at the site of infection.
"The product's novel mechanism leaves little risk of drug resistance, which is a concern with the systemic antiviral therapies used to treat herpes labialis," said Baker. "This attribute coupled with its safety profile may eventually allow NB-001 to be sold without a prescription. This will be important to those people affected by this disease, since the vast majority of herpes labialis sufferers today seek over-the-counter treatments for their cold sores."
NanoBio's pipeline of topical anti-infective products and nasally delivered vaccines are based on the company's novel NanoStat technology, a platform protected by five issued patents, as well as numerous pending filings. The issued patents provide patent protection through 2019, while pending filings would extend protection through 2029.