• PADOVA examine confirmed numerical delay in motor development and constructive developments on a number of secondary and exploratory endpoints
• Prasinezumab continues to be properly tolerated and no new security indicators have been noticed
• Roche is additional evaluating the information and can work along with well being authorities to find out subsequent steps

DUBLIN–(BUSINESS WIRE)–Prothena Company plc (NASDAQ:PRTA), right this moment introduced outcomes from the Part IIb PADOVA examine performed by companion Roche investigating prasinezumab in 586 individuals with early-stage Parkinson’s illness, handled for at least 18 months whereas on steady symptomatic therapy. Prasinezumab confirmed potential scientific impact within the major endpoint of time to confirmed motor development with a HR=0.84 [0.69-1.01] and p=0.0657. The impact of prasinezumab was extra pronounced in a pre-specified analysis within the inhabitants handled with levodopa (75% of individuals), HR=0.79 [0.63-0.99] and nominal p=0.0431. Pre-specified supplementary covariate-adjusted analyses of those endpoints demonstrated nominally important results on the first endpoint (HR=0.81 [0.67-0.98]; nominal p=0.0334) and within the levodopa subgroup (HR=0.76 [0.61-0.95]; nominal p=0.0175). Constant constructive developments throughout a number of secondary and exploratory endpoints have been additionally noticed. Prasinezumab continues to be properly tolerated and no new security indicators have been noticed within the examine.

The Part IIb PADOVA outcomes together with prior scientific examine outcomes will inform future scientific growth, together with examine design, statistical analysis, and applicable analysis of affected person sub-groups, of prasinezumab as a possible first-in-class disease-modifying therapy for sufferers with Parkinson’s illness.

The outcomes from the Part 2b PADOVA examine are a big step ahead to probably carry the primary disease-modifying therapy choice to the tens of millions of people residing with Parkinson’s illness and their households, said Gene Kinney, Ph.D., President and Chief Government Officer, Prothena. As pioneers in growing the primary anti-alpha synuclein focusing on antibody, we stay up for Roche presenting the outcomes from the PADOVA examine at an upcoming medical convention and sharing with well being authorities to find out essentially the most applicable path ahead.

The Part II PASADENA and Part IIb PADOVA open-label extension research will proceed with a view to discover the noticed results in each research. Roche will proceed to judge the information and work along with well being authorities to find out subsequent steps.

Full outcomes from the PADOVA examine can be introduced at an upcoming medical assembly.

About prasinezumab

Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated α-syn and cut back neuronal toxicity. By focusing on the build-up of α-syn protein within the mind, prasinezumab can probably forestall additional accumulation and spreading between cells, thereby slowing down the development of the illness. The proof supporting focusing on α-syn aggregates as a mechanism of motion in Parkinson’s illness is predicated on a variety of scientific proof within the subject.

Prasinezumab is at the moment being assessed in ongoing open-label extensions of the Part II PASADENA and Part IIb PADOVA research. 4-year knowledge from the PASADENA examine confirmed potential proof of sustained slowing of motor development in comparison with a matched PPMI pure historical past examine cohort, revealed within the October 2024 version of Nature Medication. The PASADENA delayed-start (n = 94) and early-start (n = 177) teams confirmed a slower decline (a smaller enhance in rating) in MDS“UPDRS Half III scores within the OFF state (delayed begin, ˆ’51%; early begin, ˆ’65%) than did the PPMI exterior comparator (n = 303). The protection database for prasinezumab consists of knowledge from greater than 900 Parkinson’s illness examine individuals which were handled with the investigational drugs, together with greater than 500 who have been handled over 1.5-5 years.

Roche entered right into a Licensing, Growth, and Commercialization settlement with Prothena in December 2013 to develop and commercialize monoclonal antibodies focusing on α-syn, comparable to prasinezumab, for the potential therapy of Parkinson’s illness.

In regards to the PADOVA examine

PADOVA is a Part IIb multicenter, randomized, double-blind trial evaluating the efficacy and security of prasinezumab in contrast with placebo in 586 randomized sufferers with early-stage Parkinson’s illness who have been on steady symptomatic therapy (steady doses of levodopa or monoamine oxidase-B inhibitor as monotherapy for greater than three months at baseline). Sufferers obtain month-to-month intravenous doses of prasinezumab 1500 mg or placebo each 4 weeks for not less than 76 weeks. That is adopted by a two-year open-label extension section by which all individuals obtain lively therapy, which is at the moment ongoing.

The first endpoint of PADOVA is the time to confirmed motor development of Parkinson’s illness ( ‰¥5-point enhance in Motion Dysfunction Society-Unified Parkinson’s Illness Score Scale [MDS-UPDRS] Half III rating assessed in OFF remedy state). A 5-point enhance in MDS-UPDRS Half III represents a clinically significant motor development occasion (Trundell et al., in press).

About Parkinson’s illness

Parkinson’s illness is a power, progressive and debilitating neurodegenerative illness that has a devastating affect on sufferers and households. Parkinson’s illness is characterised by the gradual lack of neurons that make dopamine and different nerve cells, and the event of motor and non-motor signs which will seem years earlier than prognosis. Signs can range extensively between people and illness development will not be predictable, by which signs can develop step by step over time or all of a sudden. Medical prognosis of Parkinson’s illness is late within the illness course and at the moment primarily based solely on motor signs, with non-motor signs typically previous prognosis by up to twenty years.

About Prothena

Prothena Company plc is a late-stage scientific biotechnology firm with experience in protein dysregulation and a pipeline of investigational therapeutics with the potential to alter the course of devastating neurodegenerative and uncommon peripheral amyloid ailments. Fueled by its deep scientific experience constructed over a long time of research, Prothena is advancing a pipeline of therapeutic candidates for plenty of indications and novel targets for which its skill to combine scientific insights round neurological dysfunction and the biology of misfolded proteins may be leveraged. Prothena’s pipeline consists of each wholly-owned and partnered applications being developed for the potential therapy of ailments together with AL amyloidosis, ATTR amyloidosis with cardiomyopathy, Alzheimer’s illness, Parkinson’s illness and plenty of different neurodegenerative ailments. For extra info, please go to the Firm’s web site at www.prothena.com and observe the Firm on Twitter @ProthenaCorp.

Ahead-Trying Statements

This press release comprises forward-looking statements. These statements relate to, amongst different issues, the therapy potential, design, and proposed mechanism of motion prasinezumab; plans for ongoing and future scientific trials of prasinezumab; plans to work with well being authorities to find out subsequent steps for prasinezumab; and the anticipated reporting knowledge from the PADOVA scientific trials. These statements are primarily based on estimates, projections and assumptions which will show to not be correct, and precise outcomes may differ materially from these anticipated attributable to identified and unknown dangers, uncertainties and different elements, together with however not restricted to these described within the Danger Elements sections of our Quarterly Report on Kind 10-Q filed with the Securities and Change Fee (SEC) on November 12, 2024, and discussions of potential dangers, uncertainties, and different essential elements in our subsequent filings with the SEC. We undertake no obligation to replace publicly any forward-looking statements contained on this press release on account of new info, future occasions, or adjustments in our expectations.

Covariates used for adjustment: Medicine at baseline, H&Y stage, DaT-SPECT, Age, Intercourse, Baseline dependent parameter

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Michael Bachner, Senior Director, Company Communications
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650-417-1974, mark.johnson@prothena.com

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