DNA Biomedical Solutions Ltd. (TASE: DNA) subsidiary Entera Bio Ltd. today announced favorable interim results of the second stage its Phase I clinical trial for its oral treatment for osteoporosis. The company successfully achieved the maximum concentration (Cmax) of the active ingredient in the blood after previously demonstrating the safety and absorption (pharmacokinetics) of the active ingredient.
Osteoporosis treatments are currently administered by injection, and Entera Bio's oral treatment achieved Cmax levels equal to levels of intravenous treatments.
Entera Bio's oral drug is based on an intravenous drug for osteoporosis that has already been extensively tested and found safe and effective, and had $930 million in sales in 2011
Entera Bio is developing a range of oral drugs based on biological molecules using a drug-delivery system that protects and stabilizes peptides during passage through the gastrointestinal tract and also facilitates their absorption across the lining of the tract. The technology is based on a combination of molecules that promote the absorption of the drug with molecules that protect it from the harsh chemical environment of the stomach.
The Phase I clinical trial is being conducted at Hadassah Medical Organization at Ein Kerem in Jerusalem. The company previously reported that no adverse side effects were recorded in the 12 volunteers participating in the trial. The trial is continuing to maximize the drug's characteristics so that it will be able to replace the intravenous treatment. The company expects to receive the final results of the clinical trial in a few months, after which it will submit an investigational new drug (IND) application with the US Food and Drug Administration (FDA).
Entera Bio says that the drug on which it is basing its oral treatment had $930 million in sales in 2011, out of the $11 billion osteoporosis treatment market.
DNA Biomedical's share price rose 32.1% by midday to NIS 0.14, giving a market cap of NIS 27 million.
Published by Globes [online], Israel business news - www.globes-online.com - on September 27, 2012
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