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 effectsData analysis also confirmed patients treated with P2B001 developed significantly less new-onset excessive daytime sleepiness when compared to marketed pramipexole REHOVOT, Israel, April 23, 2023 (GLOBE NEWSWIRE) — 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.” P2B001 Clinical Data Presentations Abstract TitleAbstract #PresentationLead AuthorP2B001 significantly reduced risk of daytime sleepiness: results from a randomized controlled phase 3 trial with active pramipexole arm in early Parkinson’s disease (PD)2396POSTER 001Neighborhood 11Sunday, April 2311:45am—12:45pmP2: Movement Disorders: Clinical Trials in Parkinson’s Disease 2Kreitzman, D., et. al.P2B001 (low dose combination of extended-release pramipexole and rasagiline) versus titrated extended-release pramipexole in the management of early Parkinson’s disease: Exploratory findings from a randomized, controlled trial.3733ORAL 010Tuesday, April 255:18pmS32: Movement Disorders: TrialsElmer, L.,et. al. 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. 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. _____________________________i Amara et al, J Neurol Neurosurg Psychiatry, 2017; Suzuki J Park Dis, 2021; Avorn et al, Arch Neurol, 2005 Contact:Dan TelemanPresidentPharma Two B Ltd.Cell. + 972-54-550-0804email: dan@pharma2b.com www.pharma2b.com U.S. media contact:Cali MangelAssociate DirectorCali.Mangel@calciumusa.com 215-694-1577