Myung In’s Parkinson’s Tx demonstrates efficacy

A Parkinson’s treatment that Myung In owns exclusive license of demonstrates efficacy in Phase 3 trial

Fixed-dose combination of pramipexole·rasagiline shows significant improvement over existing treatment

Plans to release in market 2023 after applying for authorization next year…will be distributed exclusively by Myung In Pharm

A Parkinson’s disease treatment that Myung In Pharm has acquired an exclusive licensing agreement from an Israeli pharmaceutical company - 'P2B001 (Fixed-dose combination of pramipexole+rasagiline)’ – has demonstrated its safety and efficacy at a global Phase III clinical trial.

 

According to the topline results announced by the Israeli pharmaceutical company Pharma Two B Ltd.

 

(P2B), P2B001 successfully met its primary and key secondary endpoints and demonstrated statistically significant benefit over existing treatments.

 

A total of 544 patients with early-stage Parkinson's disease in 70 centers in the US, Europe, and Canada were randomized to four treatment arms: P2B001 (pramipexole 0.6mg + rasagiline 0.75mg combination); pramipexole ER capsule (pramipexole 0.6 mg); rasagiline ER capsule (rasagiline 0.75mg); and the currently marketed pramipexole ER capsules titrated to an optimal dose for each individual.

 

Patients in each treatment arm were administered their respective dose once a day for 12 weeks.

 

The primary endpoint was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS, defined as the sum of parts II and III) for P2B001 as compared to each of its components over 12 weeks.

 

Results showed that P2B001 improved the total UPDRS score by 2.66 points compared to the pramipexole 0.6mg-treated arm (p=0.0018) and by 3.30 points compared to the rasagiline-treated arm (p=0.0001).

 

Also, P2B001 showed significant improvement over its comparators in the secondary endpoint, Epworth Sleepiness Scale (ESS) score.

 

From a safety prospect, P2B001 significantly reduced adverse events including sleepiness and orthostatic hypotension compared to the pramipexole ER capsule.

 

The company explained that the trial results support the use of P2B001 as first-line treatment in patients with early-stage Parkinson's disease, once a day, without the need for titration.

 

Hang Myung Lee, CEO/President of Myung In Pharm, said, “With the Phase III clinical trial results, we have now secured data that P2B001 has superior efficacy and a more significant safety profile over each of its individual components as well as the currently marketed pramipexole ER capsules.

 

We believe that P2B001 could become an important new option when considering the long-term care plan that needs to be set for early-stage Parkinson's disease and the superior efficacy demonstrated in the trial.” P2B plans to submit a New Drug Application to the FDA next year.

 

Myung In Pharm also plans to apply for marketing authorization of P2B001 to the Ministry of Food and Drug Safety in 2022 and release the drug in Korea in 2023.

 

Myung In Pharm had acquired the exclusive license for the commercialization of P2B001 in Korea through an equity investment in P2B in November this year.