Pharma Two B Doses First Patients in Early-stage Parkinson’s Phase 3 Trial

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by Alice Melão |

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P2B001 clinical trial

Israel’s Pharma Two B has dosed the first patients in a Phase 3 trial to evaluate the safety and efficacy of its drug candidate P2B001 to treat early-stage Parkinson’s disease.

P2B001 combines low-dose pramipexole and rasagiline, sold under the brand names Mirapex and Azilect. This new approach takes advantage of the well-known therapeutic effects and good safety profile of both Parkinson’s drugs, and combines it with Pharma Two B’s proprietary sustained-release formulation.

Given in low, controlled doses, P2B001 should manage symptoms better than existing drugs alone or in combination.

The trial (NCT03329508) will enroll 525 patients with untreated Parkinson’s disease, and will take place at about 70 sites in  the United States, Canada and Europe.

Researchers will divide patients into four treatment groups. The first will receive a once-daily P2B001 (pramipexole 0.6 mg/rasagiline 0.75 mg) combination product; the second, pramipexole 0.6 mg once a day; the third, rasagiline 0.75 mg once daily; and the fourth, pramipexole extended-release oral tablet titrated to optimal dose (1.5, 3.0 or 4.5 mg).

Each subject will participate in the study for 18 weeks including a 30-day screening period, a 12-week treatment period, and a two-week follow-up period.

The trial’s primary outcome is superiority of P2B001 (0.6/0.75 mg) compared to its individual components, pramipexole and rasagiline, on the total Unified Parkinson’s Disease Rating Scale (UPDRS) score.

Secondary outcomes include superiority of P2B001 (0.6/0.75 mg) as compared to pramipexole extended-release on the Epworth Sleepiness Scale (ESS) score, and efficacy of P2B (0.6/0.75 mg) as compared to its individual components in the change of Total Parkinson’s Disease Questionnaire 39 (PDQ39) score.

“We believe P2B001 has the potential to become a leading therapy for early stage PD,” Nurit Livnah, CEO of Pharma Two B, said in a press release. “Pharma Two B is focused on successfully completing our Phase 3 as planned and preparing for product launch in 2020. P2B001, once approved, is expected to provide early stage Parkinson’s patients with effective treatment with an improved safety profile.”

Advancing P2B001 into a Phase 3 trial was supported by positive results from the previous Phase 2b pivotal study (NCT01968460) in early-stage Parkinson’s patients.

The trial evaluated the efficacy of daily administration of two fixed doses of P2B001 — pramipexole 0.3 mg plus rasagiline 0.75 mg, or pramipexole 0.6 mg and rasagiline 0.75 mg — for up to 12 weeks compared to placebo. The study included 149 participants at 29 U.S. sites.