Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs, announced today the successful results of the company's Phase IIb pivotal study of P2B001 for the treatment of early stage Parkinson's Disease (PD). P2B001 is a combination of low dose pramipexole and low dose rasagiline administered as a proprietary sustained release formulation. The study, titled A Phase IIb, Twelve Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects with Early Parkinson's Disease, met primary and secondary clinical endpoints for both dose combinations. Specifically, the results showed:
- Overall improvement of 5.97 UPDRS points for the high dose combination, leading to a significant change of 4.67 UPDRS points compared to placebo (P<0.001)
- Overall improvement of 5.14 UPDRS points in the low dose combination, leading to a significant change of 3.84 UPDRS units compared to placebo (P<0.001)
- A favorable safety profile
One hundred and forty-nine patients participated in the study which was conducted at 29 clinical sites throughout the US and Israel. C. Warren Olanow, M.D., Professor of Neurology and Neuroscience at the Mount Sinai School of Medicine in New York and CEO of Clintrex LLC, and Karl Kieburtz, M.D., Professor of Neurology, Public Health Science and Environmental Medicine at the University of Rochester and President of Clintrex LLC were the clinical leaders of the study.
An estimated seven to ten million people worldwide are living with Parkinson's disease (PD), a neurodegenerative disorder of the central nervous system. The cardinal symptoms of PD include: tremors, slowed movement (bradykinesia), rigid or stiff muscles, and impaired posture, balance, and walking.
The current gold standard treatment for treating PD is Levodopa, but long term use of Levodopa is associated with severe side effects over time, that include dyskinesia (uncontrolled involuntary movement) and off periods (hours of time when the patient suffers from a return of parkinsonian features). To delay this situation, physicians often prescribe other drugs at the early stage of the illness to delay the introduction of levodopa. Though these drugs are not associated with motor complications, they are not as effective as Levodopa and can result in serious unwanted side effects. Therefore, there is an unmet medical need for a safe and effective treatment of early PD that allows a delay in the introduction of Levodopa and the risk of Levodopa associated motor complications.
"Pharma Two B's P2B001 combines two non-Levodopa drugs that have been individually approved for the treatment of early stage Parkinson's disease, in a sustained release profile. Given as low dose monotherapies, the anti-Parkinsonian effect of these drugs given individually is limited, while in higher doses they can be associated with potentially serious side effects. In preclinical studies, we observed that a low dose combination of these two drugs administered in a sustained release formulation has synergistic effects leading to notable efficacy and a very good safety profile," said Pharma Two B CEO, Dr. Nurit Livnah.
Dr. Livnah continued, "We are now thrilled to confirm similar results in our Phase IIb clinical study, showing that Pharma Two B's combination product has a significant anti-Parkinsonian effect in both low doses tested, with a very good safety profile. Moreover, P2B001 provided benefits similar to those observed with the higher doses currently prescribed to PD patients. This means that with P2B001, PD patients may be able to achieve clinical benefits comparable to current treatments but with lower doses and less risk of serious side effects."
According to Dr. C Warren Olanow, "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. This logical and simple approach should be of value for early PD patients."
"The exciting news today is pivotal for Pharma Two B, which has a defined goal to provide an effective therapy with minimal side effects that will positively impact the lives of those with early stage PD. Based on the positive results of the Phase IIb pivotal study, we can now move forward to immediately initiate the single Phase III clinical trial needed for registration, via the 505(b)(2) pathway, and to bring P2B001 to market. We are focused, determined and ready to continue working hard to achieve this end goal. We are currently examining ways to finance the Phase III trial either through IPO or a strategic agreement with a marketing partner," said chairman of the board of Pharma Two B Mr. Ehud Marom.