D2 receptor agonists(Dopamine D2 receptor agonists), D3 receptor agonists(Dopamine D3 receptor agonists), D4 receptor agonists(Dopamine D4 receptor agonists)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseOther Diseases

Active Indication-

Inactive Indication

Young onset Parkinson disease

Originator Organization

Pharma Two B Ltd.

Active Organization-

Inactive Organization

Pharma Two B Ltd.

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

Structure

Molecular FormulaC13H17NO3S

InChIKeyJDBJJCWRXSVHOQ-UTONKHPSSA-N

CAS Registry161735-79-1

View All Structures (2)

Clinical Trials associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

NCT03329508 / CompletedPhase 3

A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease. The two drugs work in two different mechanisms that help each other, so there is a reason to believe that their combined activity will be better than each individual drug, and that lower doses can be used without losing the therapeutic effect. Thus, the development of P2B001 is intended to provide a combination of low doses of these two drugs, in an improved formulation, that is hoped to be more effective in controlling Parkinson's disease symptoms and with less side effects than each of the drugs taken alone or the current available commercial drugs taken together. In a previously completed clinical trial a significant improvement in Parkinson's disease symptoms was seen in patients treated with P2B001 compared to patients that were treated with placebo.
In this phase 3 study , the safety and efficacy of P2B001 will be assessed by comparing P2B001 to its individual components pramipexole and rasagiline. This will be done by monitoring the motor and non-motor symptoms, evaluating responses participants provide on questionnaires relating to Parkinson's disease and quality of life that will be completed on every visit. In addition, this study will also compare P2B001 to a marketed drug of pramipexole ER. Approximately 525 patients will participate in this research study and the participation in this study will last between 14 to 18 weeks.

Start Date19 Jan 2018

Sponsor / Collaborator

Pharma Two B Ltd.

NCT01968460 / CompletedPhase 2/3

A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.
Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.

Start Date01 Dec 2013

Sponsor / Collaborator

Pharma Two B Ltd.

100 Clinical Results associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

100 Translational Medicine associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

100 Patents (Medical) associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

Literatures (Medical) associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

01 Feb 2024·Movement disorders : official journal of the Movement Disorder Society

A Randomized Phase 3 Study Comparing P2B001 to its Components (Low‐Dose Extended‐Release Rasagiline and Pramipexole) and to Optimized Doses of Marketed Extended‐Release Pramipexole in Early Parkinson's Disease

Article

Author: Kieburtz, Karl ; Hauser, Robert A ; Kreitzman, David L ; de Marcaida, Joy Antonelle ; Burdick, Daniel J ; McGarry, Andrew ; Gil, Ramon A ; Elmer, Lawrence W ; Olanow, C Warren ; Dhall, Rohit

Abstract:

Background:

There remains uncertainty as to the optimal way to initiate therapy for Parkinson's disease (PD) to maximize benefit and minimize adversity.

Objectives:

The objective was to determine if P2B001 (a fixed, low‐dose, extended‐release [ER] combination of pramipexole 0.6 mg and rasagiline 0.75 mg) is superior to each of its components and compare its safety and efficacy to optimized treatment with marketed doses of pramipexole‐ER.

Methods:

This was a 12‐week, double‐blind study (NCT03329508). Total of 544 untreated patients with PD were randomized (2:2:2:1) to treatment with P2B001, its individual components (pramipexole‐ER 0.6 mg or rasagiline‐ER 0.75 mg), or commercial doses of pramipexole‐ER titrated to optimal dose (1.5–4.5 mg). The primary endpoint was change from baseline to week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III. The key secondary endpoint was the change from baseline in the Epworth Sleepiness Scale (ESS) for P2B001 versus the titrated dose of pramipexole‐ER.

Results:

P2B001 provided superior efficacy compared to each of its components; mean (95% CI) treatment differences in UPDRS II + III scores were −2.66 (95% CI, −4.33 to −1.00) versus pramipexole‐ER 0.6 mg (P = 0.0018) and − 3.30 (95% CI, −4.96 to −1.63) versus rasagiline‐ER 0.75 mg (P < 0.0001). P2B001 had comparable efficacy with the titrated dose of pramipexole‐ER (mean, 3.2 mg), but significantly less worsening in daytime‐sleepiness (ESS treatment difference: −2.66 [95% CI, −3.50 to −1.81]; P < 0.0001). P2B001 was well‐tolerated with fewer sleep‐related and dopaminergic adverse events than titrated doses of pramipexole‐ER including somnolence, orthostatic hypotension, and neuropsychiatric side effects.

Conclusions:

P2B001 had superior efficacy to its individual components and was comparable with commercially used doses of pramipexole‐ER with less worsening of sleepiness and fewer dopaminergic adverse events. These findings support considering once‐daily P2B001 as initial therapy for patients with early PD. © 2023 International Parkinson and Movement Disorder Society.

01 May 2022·Advances in therapyQ3 · MEDICINE

P2B001 (Extended Release Pramipexole and Rasagiline): A New Treatment Option in Development for Parkinson’s Disease

Q3 · MEDICINE

Review

Author: Oren, Sheila ; Hauser, Robert A ; Friedman, Hadas ; Giladi, Nir ; Brotchie, Jonathan ; Poewe, Werner ; Litman, Pninit

Despite levodopa's superior efficacy in reducing the motor symptoms of Parkinson's disease (PD), its risk to induce motor complications requires consideration of the pros and cons of initiating treatment with levodopa-sparing strategies. The current drive toward early levodopa monotherapy is primarily driven by safety and tolerability concerns with dopamine agonists and only mild efficacy of other available approaches. Recently, P2B001, a novel once-daily combination of low-dose, extended-release formulations of pramipexole and rasagiline (0.6 mg and 0.75 mg respectively), has entered clinical development. In this drug evaluation, we review the preclinical and current clinical data for P2B001 and its components. The P2B001 combination has the potential to provide greater efficacy than either pramipexole or rasagiline alone and a better tolerability profile compared to higher dosage dopamine agonist monotherapy, while maintaining the advantage of lower motor complication risk than levodopa.

01 May 2017·Movement disorders : official journal of the Movement Disorder SocietyQ1 · MEDICINE

A randomized trial of a low‐dose Rasagiline and Pramipexole combination (P2B001) in early Parkinson's disease

Q1 · MEDICINE

Article

Author: Klepiskaya, Olga S. ; Friedman, Hadas ; Kreitzman, David L. ; Litman, Pninit ; Kieburtz, Karl ; Leinonen, Mika ; Linvah, Nurit ; Hauser, Robert A. ; Russell, David S. ; the P2B Study Group, for ; Giladi, Nir ; Kadosh, Shaul ; Olanow, C. Warren ; Lew, Mark F. ; Elmer, Lawrence

ABSTRACT:

Background:

Rasagiline and pramipexole act to improve striatal dopaminergic transmission in PD via distinct and potentially synergistic mechanisms. We performed a placebo‐controlled study to determine whether 2 doses of a novel slow‐release, low‐dose combination of rasagiline and pramipexole (P2B001) are effective and have a good safety profile in patients with early untreated PD.

Methods:

Previously untreated patients with early PD were randomized (1:1:1) to once‐daily treatment with P2B001 (0.3 mg pramipexole/0.75 mg rasagiline), P2B001 (0.6 mg pramipexole/0.75 mg rasagiline) or placebo in a 12‐week multicenter double‐blind, placebo‐controlled trial. The primary endpoint was the change from baseline to final visit in Total‐UPDRS score versus placebo. Secondary measures included responder analyses of patients achieving ≥4 UPDRS point reduction, and changes in Parkinson Disease Quality of Life Scale–39 and UPDRS activities of daily living and motor scores.

Results:

A total of 149 participants were randomized and 136 (91.3%) completed the study. Adjusted mean change from baseline to final visit versus placebo in Total‐UPDRS score was −4.67 ± 1.28 points for the P2B001 0.6/0.75 mg group (P = .0004) and −3.84 ± 1.25 points for the 0.3/0.75 mg group (P = .003). Significant benefits were also observed for both doses in the responder analysis (P = .0002 and P = .0001), Parkinson Disease Quality of Life Scale–39 scores (P = .05 and P = .01), and the UPDRS motor (P = .02 and P = .006) and activities of daily living (P = .005 and P = .0004) subscores. Adverse events of P2B001 were comparable to placebo apart from transient nausea and somnolence, which were more common with P2B001 treatment.

Conclusions:

News (Medical) associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

09 Nov 2023

·www.biospace.com

Pharma Two B Announces Publication of Positive Phase 3 Study Results of P2B001, an Investigational Treatment for Early Parkinson’s Disease, in Movement Disorders

Demonstrated that P2B001 provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep–related and dopaminergic side effects associated P2B001 provided superior efficacy on motor symptoms and activities of daily living, compared to each of its individual components The convenient dosing of P2B001, as a no-titration, once-daily single pill, may be a valuable option for patients, neurologists, and particularly non-specialists who are often the only physicians treating PD patients REHOVOT, Israel, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pharma Two B Ltd., a private, late-stage pharmaceutical company, today announced that data from a Phase 3 study evaluating P2B001, a fixed, low-dose extended-release (ER) combination of pramipexole 0.6 mg and rasagiline 0.75 mg, were published in Movement Disorders. Results from the international, multicenter, randomized, double-blind parallel-group study evaluated the safety and efficacy of P2B001 in patients with early Parkinson’s disease compared to its components and to commercial doses of the dopamine agonist pramipexole (mean 3.2 mg per day). The study included 544 untreated patients with Parkinson’s disease who were randomized (2:2:2:1) to treatment with P2B001, its individual components (pramipexole-ER 0.6 mg or rasagiline-ER 0.75 mg), or marketed PramiER individually titrated to optimal dose (1.5-4.5 mg). “The present study demonstrates that each component contributes to the benefits of P2B001, and that it provides benefits comparable to commercially used doses of Pramipexole ER but with a reduced frequency of sleep-related and dopaminergic adverse events," said C. Warren Olanow, M.D., FRCPC, Chairman Emeritus of the Department of Neurology and Professor Emeritus in the Department of Neuroscience at the Mount Sinai School of Medicine in New York City. Further, he stated that “P2B001 is a once-a-day treatment that requires no titration. As such, if approved, P2B001 represents an important consideration for initiating treatment in patients with early PD.” “P2B001 represents a novel and easy-to-use therapeutic approach, as there has been a clear unmet need for a once-daily treatment that has demonstrable efficacy and safety, requires no titration and has a lower incidence of excessive daytime sleepiness, a commonly reported side effect among people with PD, often caused by dopamine agonist treatment,1-3” said Robert Hauser, M.D., M.B.A., Director, Parkinson’s Disease & Movement Disorders Center, University of South Florida. The primary endpoint was change from baseline to week 12 in Unified Parkinson’s Disease Rating Scale (UPDRS) parts II and III comparing P2B001 to its individual components. The key secondary endpoint was the change from baseline to week 12 in the Epworth Sleepiness Scale (ESS) for P2B001 versus the titrated dose of commercially available PramiER. The change from baseline in total UPDRS (primary endpoint) showed that P2B001 was significantly superior to each of its individual components demonstrating that each contributed to the P2B001 benefit. Least squares mean (LSM) (standard error) treatment difference between P2B001 and pramipexole ER (PPX-ER 0.6 mg) was –2.66 ± 0.85 points (p = 0.0018), and between P2B001 and rasagiline ER (RAS-ER 0.75 mg) was –3.30 + 0.85 points (p = 0.0001). The change from baseline to week 12 in total UPDRS score between P2B001 and PramiER (individually titrated to optimal dose; mean, 3.2 mg/day) was not significantly different (–8.35 ± 0.86 vs. 7.98 ± 0.60; p = 0.7197). Analysis of the key secondary endpoint (change from baseline to week 12 in the ESS score) demonstrated no worsening in the sleepiness scale with P2B001 treatment, whereas optimized doses of PramiER (mean dose, 3.2 mg) caused significant worsening in ESS. LSM difference between groups was –2.66 ± 0.43 (p < 0.0001). P2B001 was generally well tolerated and showed fewer sleep-related and dopaminergic adverse events in comparison to commercially used doses of pramipexole ER. "We are grateful to the patients, families and clinicians who have contributed to this study as we look to deliver a new, convenient treatment option for patients with early Parkinson’s disease,” said Dan Teleman, CEO of Pharma Two B. “We look forward to moving P2B001 forward towards an NDA submission to make this potential treatment option available to patients.” About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of Parkinson’s disease (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with Parkinson’s disease. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001, which are expected to remain in effect until January 2033. About Pharma Two B Pharma Two B is a private, late-stage pharmaceutical company established in 2008 in Rehovot, Israel. Our mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience through easier administration. Our company is led by a highly experienced team in Parkinson’s disease, supported by top-tier scientific and clinical key opinion leaders and backed by a dedicated group of investors. For more information, please visit: . Forward-Looking Statements Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “will,” “expect,” “could,” “if,” “expected,”” “anticipate,”” look forward,” “believe,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the company’s future expectations and plans. The company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially. Although the company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results. Amara AW, Chahine LM, Caspell-Garcia C, et al. Longitudinal assessment of excessive daytime sleepiness in early Parkinson’s disease. JNeurol Neurosurg Psychiatry. 2017;88(8):653-662. doi:10.1136/jnnp-2016-31502 Suzuki K. Current update on clinically relevant sleep issues in Parkinson’s disease: a narrative review. J Parkinsons Dis. 2021;11(3):971-992. doi: 10.3233/JPD-202425 Avorn J, Schneeweiss S, Sudarsky LR, et al. Sudden uncontrollable somnolence and medication use in Parkinson disease. Arch Neurol. 2005;62(8):1242-1248. doi: 10.1001/archneur.62.8.1242 CONTACT INFORMATION Dan Teleman CEO Pharma Two B Ltd. Cell + 972-54-550-0804 Email: dan@pharma2b.com U.S. media contact: Cali Mangel Director Cell: 215-694-1577 Email: Cali.Mangel@calciumco.com

Clinical ResultPhase 3

24 Apr 2023

·www.globenewswire.com

Pharma Two B to Present Additional Positive Results from P2B001 Phase 3 Trial at 2023 American Academy of Neurology Annual Meeting

Results showed P2B001, a once-daily fixed-dose combination of low dose pramipexole and low dose rasagiline, showed comparable efficacy to marketed optimally titrated pramipexole, with significantly reduced sleep-related and dopaminergic side effects Data analysis also confirmed patients treated with P2B001 developed significantly less new-onset excessive daytime sleepiness when compared to marketed pramipexole Pharma Two B, a private, venture-backed, late-stage pharmaceutical company, today announced that additional results from the Phase 3 pivotal clinical trial evaluating P2B001, will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27 in Boston, MA. The data are being presented as an oral (Abstract 3733) and poster (Abstract 2396) presentation. The data in both presentations are consistent with the positive Phase 3 topline efficacy and safety results presented previously, reemphasizing the potential of P2B001, if approved, to offer a new treatment approach for people with early Parkinson’s disease (PD). Pharma Two B plans to submit a New Drug Application (NDA) for P2B001 to the U.S. Food and Drug Administration (FDA) in 2023. The Phase 3 trial was a global, multi-center, double-blind, parallel group design that enrolled 544 treatment naïve patients with PD (Hoehn-Yahr <3). The primary endpoint was the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS) for P2B001 versus its individual components. The key secondary endpoint compared the change from baseline in Epworth Sleepiness Scale (ESS) for P2B001 versus commercial pramipexole-ER (Prami-ER). Excessive daytime sleepiness (EDS) is a commonly reported side effect among people with PD, which often worsens with dopamine agonist (DA) treatmenti. “The results of this Phase 3 trial represent positive news for newly diagnosed PD patients, as there has been a clear unmet need for an initial, once-daily treatment that has demonstrable efficacy and safety, requires no titration and has a lower incidence of excessive daytime sedation compared to pramipexole monotherapy,” says Lawrence W. Elmer, M.D. Ph.D., Department of Neurology, University of Toledo College of Medicine and Life Sciences, and trial investigator. “As a clinician caring for PD patients, I know the side effects from dopamine agonists (DAs) as monotherapy for early PD may be challenging and often limit treatment options, especially for younger people who may be required to drive for their employment and also for older people who often cannot tolerate DA side effects, including excessive daytime somnolence.” The results presented in abstract 3733 demonstrate comparable changes from baseline to week 12 with P2B001 and commercial Prami-ER in total UPDRS scores (-7.98 ±0.6 vs -8.35 ±0.86, p=0.7197) and non-inferiority (post-hoc) of P2B001 was confirmed (margin of 3 points, p=0.0052). Similarly, no significant differences between P2B001 and Prami-ER were seen in total UPDRS responders (≥4-point improvement), UPDRS Part II (activities of daily living/ADL) and UPDRS Part III (motor) scores. Importantly, patients receiving P2B001 versus Prami-ER reported less dopaminergic-related side effects (44.7% vs. 66.2%) and specifically less somnolence (14.7% vs. 31.1%,) and orthostatic hypotension (2.7% vs. 12.2%,) side effects. Trial participants treated with P2B001 had better outcomes in daytime sleepiness, with significantly less worsening (shown by a lower ESS change from baseline) than that with Prami-ER (key secondary endpoint; p < 0.0001). Results highlighted in abstract 2396 show that patients treated with P2B001 developed significantly less new-onset EDS, often a limiting factor for traditional dosing of DAs. Data analysis showed the rate of new-onset EDS was significantly lower in patients treated with P2B001 (8.5%) as compared to commercial Prami-ER (35.7%; adjusted odds ratio 0.17 (95% CI: 0.08-0.36; P<0.0001). “We believe the data presented at AAN this year continue to support the development of P2B001 as a potential first-line therapy for people with PD,” says Dan Teleman, President, Pharma Two B. “Our unique and proprietary formulation shown through our dose selection, extended-release formulation, and no need for titration supports our plan to submit a New Drug Application to the U.S. Food and Drug Administration.” About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of Parkinson’s disease (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with Parkinson’s disease of all ages. Extended-release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. Pharma Two B owns worldwide granted patents for both pharmaceutical composition and method of treatment with P2B001, which are expected to remain in force until January 2033. About Pharma Two B Pharma Two B is a private, venture-backed, late-stage pharmaceutical company established in 2008 in Rehovot, Israel. Our mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that offer meaningful clinical benefits, as well as improved safety and enhanced convenience through easier administration. The company is led by a highly experienced team in Parkinson Disease, supported by top tier scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultPhase 3NDA

100 Deals associated with Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Young onset Parkinson disease	Phase 3	US	Pharma Two B Ltd.	19 Jan 2018
Young onset Parkinson disease	Phase 3	CA	Pharma Two B Ltd.	19 Jan 2018
Young onset Parkinson disease	Phase 3	DE	Pharma Two B Ltd.	19 Jan 2018
Young onset Parkinson disease	Phase 3	ES	Pharma Two B Ltd.	19 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


S32.010 (AAN2023)	Not Applicable	Parkinson Disease	-	P2B001 (low dose combination of extended-release pramipexole and rasagiline)	mxwmcijtgf(sqscbunymp) = civpxwdjrw zimmcaepnz (uivecxpqlr ) View more	-	25 Apr 2023
S32.010 (AAN2023)	Not Applicable	Parkinson Disease	-	Extended-Release pramipexole (Prami-ER)	mxwmcijtgf(sqscbunymp) = aylnoswrsp zimmcaepnz (uivecxpqlr ) View more	-	25 Apr 2023
NCT01968460 (CTgov)	Phase 2/3	Young onset Parkinson disease	149	Placebo	zzcwpaocae(urzfdttviv) = eeseniqdvr tqycxvtvop (hfsszwfipk, kxipsszdql - wowgtnmsky) View more	-	07 Apr 2023
NCT03329508 (CTgov)	Phase 3	Young onset Parkinson disease	544	Marketed Pramipexole ER	djlpwjbsws(pjfbftaopk) = hrntikpeyy pjcjwiupdp (wnrptfmnad, ngwuayjapv - sbysfrmwef) View more	-	21 Mar 2023

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Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate

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