Pharma Two B reports positive Phase III Parkinson’s drug trial

Israeli drug development company Pharma Two B Ltd. has reported positive Phase III results from a trial on a treatment that combines two existing drugs for treating Parkinson’s disease using the company’s unique extended release mechanism. The results found similar efficacy to existing treatments but with reduced side-effects such as less daytime drowsiness.

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The Rehovot-based company, which develops innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, was founded by Yoram Sela and Ehud Marom, who was part of the Teva team that developed multiple sclerosis treatment Copaxone. Since leaving Teva, Marom has founded three companies all in advanced stages of drug development, including Mapi Pharma, which has developed a slow release version of Copaxone.

Pharma Two B’s CEO is Dr. Sheila Oren, who was one of the leaders in developing Teva’s Parkinson’s treatment Azilect. She said, “There is a clear unmet medical need for an early PD treatment that can significantly improve motor symptoms and daily function, while avoiding side effects. The data from this Phase III study support our view that P2B001 can provide clinical benefits comparable to higher doses of commercially available dopamine agonists, while mitigating the side effects typically associated with this class of medicine such as somnolence, orthostatic hypotension and hallucinations. This is important for PD patients of all ages and is critical for the elderly, who typically do not tolerate side effects of dopamine agonists.”

P2B001 is a novel fixed-dose combination of extended release (ER) formulations of pramipexole (0.6mg) and rasagiline (0.75mg), with both components at lower doses than their respective marketed products. In the Phase III study, P2B001 was superior to each of its individual components as measured by the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale.

P2B001 also demonstrated comparable efficacy to a marketed pramipexole ER with significantly less daytime sleepiness (somnolence), by a reduction of 2.66 points as measured by Epworth Sleepiness Scale.

Published by Globes, Israel business news – en.globes.co.il – on December 21, 2021.

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