아르비나스가 파킨슨병 환자 대상 ARV-102의 Phase 1 임상시험 최종 데이터를 발표했습니다. 24명의 환자를 대상으로 20mg에서 80mg의 용량을 28일간 평가한 결과, LRRK2 분해 및 생체표지자 변화와 안구 운동 개선 간의 상관관계가 확인되었습니다. 다만 본 임상시험은 임상적 효능 평가를 위해 설계되지 않은 초기 단계의 탐색적 데이터입니다. 당일 거래량 가속이 관찰되었으나 초기 임상 데이터 발표로 영향은 제한적입니다.
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Arvinas Shares Novel Oculomotor and Biomarker Data from Phase 1 Clinical Trial of ARV-102 in Patients with Parkinson’s Disease
ARVN · GlobeNewswire · 10월 7일
– Data showed improvements in an objective measure of impaired eye movement associated with Parkinson’s disease, with a correlation between reductions in LRRK2 cerebrospinal fluid (CSF) biomarkers to these changes in oculomotor function and changes in synaptic biomarkers – – Findings support continued evaluation of ARV-102 as a potential therapeutic approach for neurodegenerative diseases associated with LRRK2 dysregulation – NEW HAVEN, Conn., Oct. 07, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today presented novel data from a Phase 1 clinical trial of ARV-102, an investigational PROteolysis TArgeting Chimera (PROTAC) degrader designed to specifically target and degrade leucine-rich repeat kinase 2 (LRRK2). Final data from this trial were presented as late-breaking oral and poster presentations at the 2026 International Congress of Parkinson’s Disease and Movement Disorders ® (MDS) in Seoul, Korea. “These final data from our Phase 1 study in patients with Parkinson’s disease provide further evidence that ARV-102 reaches the central nervous system, degrades LRRK2, and modulates biological pathways relevant to neurodegenerative disease,” said Ilaria Conti, MD, Ph.D., Vice President, Clinical Research at Arvinas. “Although this study was not designed to assess clinical efficacy, we are encouraged by the exploratory dose-related changes in ocular saccadic hypometria and their associations with LRRK2 degradation and changes in pathway biomarkers. These findings support further clinical evaluation of ARV-102.” The data presented augment Phase 1 clinical trial results shared earlier this year at AD/PD (The 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders) showing brain penetration and reductions of LRRK2 variant and expression-dependent endolysosomal and neuroinflammatory biomarkers, which have been shown to be elevated in neurodegenerative diseases, in the CSF. The trial evaluated oral doses of ARV-102 ranging from 20 mg to 80 mg, as well as placebo, for 28 days, in a total of 24 patients with Parkinson’s disease. Notable findings include: Dose-dependent increases in amplitude of saccadic hypometria (ASH) observed after 28 days of ARV-102 treatment compared with placebo, reflecting less severe hypometria; Decreases in biomarkers associated with endolysosomal function and neuroinflammation; Increases in biomarkers of synaptic integrity and axonal guidance; and Associations between reductions in CSF LRRK2 protein levels and improvements in both oculomotor function and changes in pathway biomarkers of endolysosomal, neuroinflammatory, and synaptic function. Additional detail on the ARV-102 data presentations at MDS 2026 follows below: Presentation Title: Phase 1 Study of ARV-102, a PROTAC LRRK2 Degrader, in Parkinson’s Disease: Oculomotor and Biomarker Data Session Number: 12 Session Title: Late-Breaking Abstracts: Parkinson's Disease Session Type: Oral Session Location: Conference Room E3, 3rd Floor Presentation Number: LBA 15 Presentation Order : 3 Presentation Duration: 5 minutes Date: Wednesday, October 7 Session Time: 12:30 - 13:30 ET Presentation Title: Phase 1 Study of ARV-102, a PROTAC LRRK2 Degrader, in Parkinson’s Disease: Oculomotor and Biomarker Data Session Type: E-Poster Session Location: E-Poster Hall, online Presentation Number: LBA 15 About ARV-102 ARV-102 is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) designed to cross the blood-brain barrier and specifically target and degrade leucine-rich repeat kinase (LRRK2), a large, multidomain scaffolding kinase with GTPase activity. Increased activity and over expression of LRRK2 have been implicated in the pathogenesis of neurological diseases, including LRRK2 genetic and idiopathic Parkinson’s disease and progressive supranuclear palsy (PSP). ARV-102 has been evaluated in a Phase 1 clinical trial in healthy volunteers and in patients with Parkinson’s disease. About Parkinson’s Disease Parkinson’s disease is a progressive brain disease that damages dopamine-producing neurons, leading to progression of symptoms including motor-related symptoms like tremors and limb stiffness, as well as non-motor symptoms including depression, sleep disorders, cognitive decline, and more. LRRK2 activity is abnormally increased in Parkinson’s disease – and both experimental studies and recent clinical data suggest that degrading LRRK2 may positively affect endolysosomal function, neuroinflammation, and synaptic function. About Arvinas Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROteolysis TArgeting Chimera (PROTAC) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas, with its partner Pfizer, developed the first U.S. Food and Drug Administration (FDA)-approved PROTAC, a type of heterobifunctional protein degrader, which has been outlicensed to Rigel Pharmaceuticals, Inc. for exclusive global development, manufacturing, and commercialization. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle for spinal-bulbar muscular atrophy, also known as Kennedy’s disease; and ARV-6723, targeting HPK1 for advanced solid tumors. Arvinas has also advanced ARV-806, targeting KRAS G12D for solid tumors, in the clinic, and previously announced plans to seek an out-licensing agreement for any additional clinical trials of ARV-806, including dose expansion or combination clinical trials. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the potential of ARV-102, including its degradation of leucine-rich repeat kinase 2 (“LRRK2”), and its potential treatment of neurodegenerative diseases associated with LRRK2 dysregulation; oculomotor and biomarker data from the Phase 1 clinical trial of ARV-102 in Parkinson’s disease supporting continued evaluation of ARV-102 as a potential therapeutic approach for neurodegenerative diseases associated with LRRK2 dysregulation; whether degrading LRRK2 may positively affect endolysosomal function, neuroinflammation, and synaptic function; and Arvinas’ plans with respect to its clinical development programs. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, development plans, future operations, prospects, plans, and objectives of management and the statements identified in the prior paragraph, are forward-looking statements. The words “ability,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “target,” “goal,” “aim,” “whether,” “will,” “would,” “could,” “reliance,” “should,” “look forward,” “seek,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas will be able to successfully conduct and complete development for its product candidates, including ARV-102, on its current timelines or at all; risks related to clinical trial results and the interpretation thereof, including with respect to ARV-102; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalents will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent other reports filed with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release. Contacts Investors: Jeff Boyle +1 (347) 247-5089 jeff.boyle@arvinas.com Media: Kirsten Owens +1 (203) 584-0307 Kirsten.Owens@arvinas.com