Top-line Results Due by Year’s End for Just-completed P2B001 Trial

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by Patricia Inacio PhD |

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Top-line results are expected to be released by the end of this year for Pharma Two B’s multinational trial investigating the safety and efficacy of P2B001 for treating early stage Parkinson’s disease.

Pharma Two B announced that its researchers have finished treating patients in the Phase 3 trial, which launched in 2017.

“We are pleased to announce the completion of the last patient visit in this Phase III study, which represents an important milestone for Pharma Two B and our P2B001 clinical program,” Sheila Oren, MD, CEO of Pharma Two B, said in a press release.

“We look forward to reviewing the top line results and anticipate that if approved, P2B001 will offer meaningful clinical benefits for early-stage PD [Parkinson’s disease] patients,” Oren said.

The medication is expected to be particularly helpful in treating “older patients who cannot tolerate the associated side effects of the current available drugs,” she added.

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P2B001 is a once-daily pill made with a combination of low-dose pramipexole and rasagiline, both approved for treating Parkinson’s. Pramipexole is sold under the brand name Mirapex while rasagiline is marketed as Azilect. Both medicines have proven therapeutic effects and good safety profiles, and are combined in P2B001 with Pharma Two B’s proprietary sustained-release formulation.

Mirapex belongs to a class of therapies called dopamine agonists that mimic the effect of dopamine — a chemical messenger essential for muscle control that is gradually lost in those with Parkinson’s — by binding to dopamine receptors. Azilect is a monoamine oxidase-B (MAO-B) inhibitor that acts to increase the levels of dopamine in the brain.

Given in low, controlled doses, P2B001 is thought to manage symptoms better than each therapy alone or in combination.

The trial (NCT03329508), which first began dosing in 2018, has randomly assigned 544 patients with early untreated Parkinson’s to one of four groups. The first group received a once-daily P2B001 (pramipexole 0.6 mg/rasagiline 0.75 mg) combination product while the second was treated with pramipexole alone (0.6 mg), once a day. A third group was given rasagiline 0.75 mg once daily, while the fourth received pramipexole extended-release oral tablets titrated to the optimal dose (1.5 to 4.5 mg).

Each patient was followed for approximately 18 weeks (about 4.5 months), which included a 30-day screening period, a 12-week treatment period, and a two-week follow-up period.

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The trial’s main goal is to assess the effectiveness of P2B001 compared with its individual components — pramipexole and rasagiline — by assessing the changes in the Unified Parkinson’s Disease Rating Scale (UPDRS) score, specifically the sum of score II and III, after 12 weeks of treatment.

The UPDRS part II and III score are standard measures used in Parkinson’s disease, in which a decrease in scores indicates the patient is now experiencing less severe symptoms. Part II assesses motor experiences of daily living and Part III motor examination.

“We are very grateful to the clinical investigators, trial participants and their families for their time and commitment,” Oren said, noting that the top-line results are expected in the fourth-quarter of this year.

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