Intec Pharma Ltd. (TASE: INTP), which develops improved formulations of existing medications, reports success in the interim results of the Phase IIb clinical trial of its accordion Levodopa pill for Parkinson's disease.
The accordion Levodopa pill was found to significantly reduce motor disturbances in patients with Parkinson's disease, and significantly reduce the daily dosage of Levodopa. Intec Pharma said that the results were, to the best of its knowledge, unprecedented compared with commercial oral Levodopa tablets.
The trial included 12 patients with advance Parkinson's disease. It was conducted at Sourasky Medical Center (Ichilov Hospital) in Tel Aviv, Rabin Medical Center (Beilinson Hospital) in Petah Tikva, and Sheba Medical Center at Tel Hashomer. The accordion Levodopa pill was found to be effective with clear statistical significance, and a statistically significant reduction in the daily dosage of the drug.
The trial also demonstrated a good safety profit and no unusual side effects were seen.
The ten patients who completed the trial according to its protocol, showed statistically significant reduction in the off time (the period when their motor capacity is severely limited). 80% of the patients achieved an average 35% reduction in off time (2.96 hours compared with 4.48 hours for commercial Levodopa), and the daily dosage was nearly halved from 6 to 3.2.
Intec Pharma said, "The success of the trial is important additional proof of the potential of the accordion technology to significantly improve current medications while preserving a high safety profile. The success in this trial is another important step in the breakthrough for greatly improving current treatments for patients."
The company added, "We believe that the interim results improve the likelihood of success in subsequent stages in the clinical trial in the coming months.
"On the basis of the company's business model and assuming that the trial is successful, we expect that it will serve as the foundation for collaborations with international pharmaceutical companies. We believe that if the formulation is approved for marketing annual sales could reach $800 million."
Intec Pharma's share price rose 5.1% to NIS 0.91, giving a market cap of NIS 128 million. The share price is 5% below its IPO price of NIS 0.95 in February.
Published by Globes [online], Israel business news - www.globes-online.com - on August 31, 2010
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