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▎Editor of WuXi AppTec's content team On December 15, 2021, Pharma Two B announced that a phase 3 clinical trial of P2B001 in patients with early Parkinson's disease (PD) reached its primary and key secondary endpoints
.
P2B001 is a new fixed-dose combination of pramipexole (0.
6 mg) and rasagiline (0.
75 mg) sustained-release preparations.
The doses of both components are lower than the doses of their respective marketed products
.
The test results show that P2B001 has a more significant effect than the single-drug treatment of its two drug components
.
In addition, P2B001, compared with the marketed pramipexole sustained-release therapy, has a similar curative effect, significantly reducing the symptoms of daytime sleepiness in patients, and is accompanied by superior safety
.
These positive results prove the potential of P2B001 as a first-line therapy for patients with early PD.
Pharma Two B plans to submit a new drug application (NDA) for this compound to the US FDA next year
.
PD is the second most common neurodegenerative disease after Alzheimer's disease.
There are approximately 10 million PD patients worldwide
.
The main motor symptoms of PD are tremor, stiffness, and impaired motor function of the limbs at rest.
Non-motor symptoms include cognitive, emotional, and sleep disorders
.
The cause of PD is the death of dopamine-producing neurons in the substantia nigra of the patient
.
The current treatment for PD is levodopa (L-DOPA), or other dopamine agonists
.
However, long-term use of levodopa may lead to sports complications, thereby aggravating the condition and reducing the quality of life
.
Pramipexole is a dopamine receptor agonist that binds to the D2 subfamily of dopamine receptors with a high degree of specificity.
It can be used alone or in combination with levodopa to treat PD
.
Rasagiline is a monoamine oxidase inhibitor that can delay the breakdown of the neurotransmitter dopamine and act as an adjuvant for levodopa and carbidopa in the treatment of PD
.
As a low-dose sustained-release combined preparation of two drugs, P2B001 only needs to be administered once a day without titration, which is very convenient in administration
.
The phase 3 clinical trial reached its primary endpoint, that is, compared with the two-component monotherapy of the drug, the unified Parkinson's disease rating scale score (UPDRS) of patients in the P2B001 group improved more than the baseline
.
Specifically, the P2B001 group is better than the pramipexole group by 2.
66 points (p=0.
0018) and better than the rasagiline group by 3.
30 points (p=0.
0001)
.
In addition to the primary endpoint of UPDRS, on the key secondary endpoints of the trial, P2B001 showed similar efficacy to the marketed pramipexole sustained-release formulation (titrated to the optimal dose for each patient; 1.
5-4.
5 mg), and reduced daytime sleepiness symptoms 2.
66 points (p<0.
0001) (assessed by Epworth Sleepiness Scale)
.
After 12 weeks, the total UPDRS scores of the P2B001 group (-7.
98 points) and the marketed pramipexole sustained-release formulation (-8.
35 points) showed similar changes
.
The specific results of the test are shown in the following table: Table source: Reference data [1] In terms of safety, P2B001 is usually well tolerated, and more than 98% of post-treatment adverse events (TEAE) are mild or moderate in severity
.
The early treatment termination rate of each treatment group was similar (between 7.
1%-9.
1%)
.
Dr.
Sheila Oren, CEO of Pharma Two B, said: “We are excited about the positive results of this phase 3 clinical trial
.
There is a significant unmet medical need for early PD treatment, and this new combination of treatments has been shown to significantly improve patients Motor symptoms and daily life functions, accompanied by very low side effects
.
Relevant data supports our view that P2B001 can provide clinical benefits similar to higher doses of marketed dopamine agonists, while reducing the side effects commonly associated with such drugs.
For example, lethargy, orthostatic hypotension and hallucinations
.
This is important for PD patients of all ages, especially the elderly, who usually cannot tolerate the side effects of dopamine agonists
.
"Reference: [1] Pharma Two B Announces Positive Topline Results from its Pivotal Phase III Study of P2B001 in Early Parkinson's Disease.
Retrieved December 15, 2021, from https:// from-its-pivotal-phase-iii-study-of-p2b001-in-early-parkinsons-disease-301445237.
html Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
P2B001 is a new fixed-dose combination of pramipexole (0.
6 mg) and rasagiline (0.
75 mg) sustained-release preparations.
The doses of both components are lower than the doses of their respective marketed products
.
The test results show that P2B001 has a more significant effect than the single-drug treatment of its two drug components
.
In addition, P2B001, compared with the marketed pramipexole sustained-release therapy, has a similar curative effect, significantly reducing the symptoms of daytime sleepiness in patients, and is accompanied by superior safety
.
These positive results prove the potential of P2B001 as a first-line therapy for patients with early PD.
Pharma Two B plans to submit a new drug application (NDA) for this compound to the US FDA next year
.
PD is the second most common neurodegenerative disease after Alzheimer's disease.
There are approximately 10 million PD patients worldwide
.
The main motor symptoms of PD are tremor, stiffness, and impaired motor function of the limbs at rest.
Non-motor symptoms include cognitive, emotional, and sleep disorders
.
The cause of PD is the death of dopamine-producing neurons in the substantia nigra of the patient
.
The current treatment for PD is levodopa (L-DOPA), or other dopamine agonists
.
However, long-term use of levodopa may lead to sports complications, thereby aggravating the condition and reducing the quality of life
.
Pramipexole is a dopamine receptor agonist that binds to the D2 subfamily of dopamine receptors with a high degree of specificity.
It can be used alone or in combination with levodopa to treat PD
.
Rasagiline is a monoamine oxidase inhibitor that can delay the breakdown of the neurotransmitter dopamine and act as an adjuvant for levodopa and carbidopa in the treatment of PD
.
As a low-dose sustained-release combined preparation of two drugs, P2B001 only needs to be administered once a day without titration, which is very convenient in administration
.
The phase 3 clinical trial reached its primary endpoint, that is, compared with the two-component monotherapy of the drug, the unified Parkinson's disease rating scale score (UPDRS) of patients in the P2B001 group improved more than the baseline
.
Specifically, the P2B001 group is better than the pramipexole group by 2.
66 points (p=0.
0018) and better than the rasagiline group by 3.
30 points (p=0.
0001)
.
In addition to the primary endpoint of UPDRS, on the key secondary endpoints of the trial, P2B001 showed similar efficacy to the marketed pramipexole sustained-release formulation (titrated to the optimal dose for each patient; 1.
5-4.
5 mg), and reduced daytime sleepiness symptoms 2.
66 points (p<0.
0001) (assessed by Epworth Sleepiness Scale)
.
After 12 weeks, the total UPDRS scores of the P2B001 group (-7.
98 points) and the marketed pramipexole sustained-release formulation (-8.
35 points) showed similar changes
.
The specific results of the test are shown in the following table: Table source: Reference data [1] In terms of safety, P2B001 is usually well tolerated, and more than 98% of post-treatment adverse events (TEAE) are mild or moderate in severity
.
The early treatment termination rate of each treatment group was similar (between 7.
1%-9.
1%)
.
Dr.
Sheila Oren, CEO of Pharma Two B, said: “We are excited about the positive results of this phase 3 clinical trial
.
There is a significant unmet medical need for early PD treatment, and this new combination of treatments has been shown to significantly improve patients Motor symptoms and daily life functions, accompanied by very low side effects
.
Relevant data supports our view that P2B001 can provide clinical benefits similar to higher doses of marketed dopamine agonists, while reducing the side effects commonly associated with such drugs.
For example, lethargy, orthostatic hypotension and hallucinations
.
This is important for PD patients of all ages, especially the elderly, who usually cannot tolerate the side effects of dopamine agonists
.
"Reference: [1] Pharma Two B Announces Positive Topline Results from its Pivotal Phase III Study of P2B001 in Early Parkinson's Disease.
Retrieved December 15, 2021, from https:// from-its-pivotal-phase-iii-study-of-p2b001-in-early-parkinsons-disease-301445237.
html Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
