Novel Parkinson’s disease therapy meets primary, secondary phase 3 endpoints
Pharma Two B, a company that uses reformulations and combinations of previously approved drugs to develop new therapies for neurological indications, announced its novel therapy for Parkinson’s disease met primary and secondary endpoints.
The drug, P2B001, combines extended-release formulations of 0.6 mg of pramipexole and 0.75 mg of rasagiline in a fixed dose. It features both components at lower doses than their respective marketed products, the company said in a press release.
Researchers assessed P2B001 in a phase 3 study and found it outperformed each of its individual components as measured via change from baseline to 12 weeks in total Unified Parkinson’s Disease Rating Scale (UPDRS Part II and III), which served as the primary endpoint. It exhibited superiority compared with the pramipexole components by 2.66 points and to the rasagiline component by 3.3 points, according to the release.
Moreover, it had similar efficacy compared with a marketed pramipexole extended release and significantly less somnolence by a 2.66-point reduction, based on the Epworth Sleepiness Scale, which was the key secondary endpoint. P2B001 fixed dose and the marketed, titrated, pramipexole extended release had comparable changes in total UPDRS scores at 12 weeks.
“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,” Sheila Oren, MD, MBA, CEO of Pharma Two B, said in the release. “The data from this phase 3 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.”
Jeffrey Berkowitz, chair of the board of Pharma Two B, noted the company intends to complete the regulatory submissions and prepare for a commercial launch.
“Importantly, these robust results are consistent with our prior pivotal double-blind placebo-controlled phase 2b study of P2B001 in PD, which successfully met all primary and secondary endpoints,” Berkowitz said in the release. “Based on the phase 2b data and the phase 3 topline results, we are preparing the regulatory submission for P2B001 and plan to submit a new drug application to the FDA in 2022.”