Pharma Two B has stepped up its hunt for financing after its Parkinson's disease combination drug came through a Phase IIb trial. The data have given Pharma Two B the confidence to start talking up a possible IPO or partnership deal as it moves toward gathering the cash needed for a pivotal study.
Rehovot, Israel-based Pharma Two B posted data from the Phase IIb trial this week. Mount Sinai School of Medicine's Dr. Warren Olanow co-led the trial, which enrolled 149 people with early-stage Parkinson's at 29 sites in the U.S. and Israel. Participants randomized to receive either of the two doses of Pharma Two B's sustained-release pramipexole-rasagiline scored better on the combination unified Parkinson's disease rating scale (UPDRS) than those who were given a placebo. Patients in the higher-dose arm showed the greatest improvement, 4.67 UPDRS points compared to placebo.
Olanow thinks the data suggest the combination can play a role in the care of early-stage Parkinson's disease. "The demonstration that significant anti-Parkinsonian benefits can be achieved with once a day administration of low doses of a combination extended release product provides an opportunity to effectively treat PD patients in the early stages of the disease with a very low risk of inducing serious side effects," he said in a statement. "This logical and simple approach should be of value for early PD patients."
Pharma Two B created its investigational drug by combining low doses of the dopamine agonist pramipexole and monoamine oxidase inhibitor rasagiline, forms of which are sold by Boehringer Ingelheim and Teva ($TEVA), respectively. The use of existing drugs means Pharma Two B can seek approval under the 505(b)(2) pathway, positioning it to bring the drug to market on the strength of a single Phase III trial. Attention at Pharma Two B has now turned to how to finance the pivotal trial, with an IPO or partnership deal both potentially attractive to the company.
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