ASSESSMENT OF THE BRAIN DEPOSIT OF TAU 4R DETECTED BY BRAIN PET WITH 18F-PI2620 IN PROGRESSIVE SUPRANUCLEAR PALSY COMPARED TO CONTROLS WITHOUT NEURODEGENERATIVE TAUOPATHY 4R: A CLINICAL TRIAL - CUN-PETNeuroTau

Start Date11 Dec 2023

Sponsor / Collaborator

University of Navarra

NCT05651516 / RecruitingEarly Phase 1IIT

Effects of Opioid Use Disorder and Non-fatal Overdose on Tau Pathology; a [18F]PI-2620 PET/CT Study

The investigators plan to enroll up to 60 adult subjects in this study. There will be three groups of up to 20 subjects each in this study.
Group 1: individuals with OUD and a history of at least one opioid-related OD in the past 5 years that required naloxone treatment reversal: OUD/OD+ Group 2: individuals with OUD without a lifetime history of opioid-related OD OUD/OD- Group 3: Healthy controls without a lifetime OUD: HCs PET/CT imaging will be used to evaluate the uptake of tau in the brain using the investigational radiotracer [18F]PI-2620. Each subject will have one [18F]PI-2620 positron emission tomography/computed tomography (PET/CT) scan performed.

Start Date25 Apr 2023

Sponsor / Collaborator

University of Pennsylvania

[+1]

DRKS00024770 / RecruitingNot Applicable

[18F]PI-2620 tau PET in frontotemporal dementia - FTAUD

Start Date01 Jan 2023

Sponsor / Collaborator

Universität Leipzig

100 Clinical Results associated with Izaflortaucipir (18F)

100 Translational Medicine associated with Izaflortaucipir (18F)

100 Patents (Medical) associated with Izaflortaucipir (18F)

Literatures (Medical) associated with Izaflortaucipir (18F)

01 Jun 2024·Acta Neuropathologica

Head-to-head comparison of [18F]-Flortaucipir, [18F]-MK-6240 and [18F]-PI-2620 postmortem binding across the spectrum of neurodegenerative diseases

Article

Author: Amaral, Ana C ; Johnson, Keith ; Moon, S-H ; Scapellato, Margaret ; Frosch, Matthew P ; Gómez-Isla, Teresa ; Neelamegam, Ramesh ; Dhaynaut, Maeva ; El Fakhri, Georges ; Kumar, Sunny ; Normandin, Marc D ; Aguero, Cinthya ; Carazo-Casas, Carlos

AbstractWe and others have shown that [18F]-Flortaucipir, the most validated tau PET tracer thus far, binds with strong affinity to tau aggregates in Alzheimer's (AD) but has relatively low affinity for tau aggregates in non-AD tauopathies and exhibits off-target binding to neuromelanin- and melanin-containing cells, and to hemorrhages. Several second-generation tau tracers have been subsequently developed. [18F]-MK-6240 and [18F]-PI-2620 are the two that have garnered most attention. Our recent data indicated that the binding pattern of [18F]-MK-6240 closely parallels that of [18F]-Flortaucipir. The present study aimed at the direct comparison of the autoradiographic binding properties and off-target profile of [18F]-Flortaucipir, [18F]-MK-6240 and [18F]-PI-2620 in human tissue specimens, and their potential binding to monoamine oxidases (MAO). Phosphor-screen and high resolution autoradiographic patterns of the three tracers were studied in the same postmortem tissue material from AD and non-AD tauopathies, cerebral amyloid angiopathy, synucleopathies, transactive response DNA-binding protein 43 (TDP-43)-frontotemporal lobe degeneration and controls. Our results show that the three tracers show nearly identical autoradiographic binding profiles. They all strongly bind to neurofibrillary tangles in AD but do not seem to bind to a significant extent to tau aggregates in non-AD tauopathies pointing to their limited utility for the in vivo detection of non-AD tau lesions. None of them binds to lesions containing β-amyloid, α-synuclein or TDP-43 but they all show strong off-target binding to neuromelanin and melanin-containing cells, as well as weaker binding to areas of hemorrhage. The autoradiographic binding signals of the three tracers are only weakly displaced by competing concentrations of selective MAO-B inhibitor deprenyl but not by MAO-A inhibitor clorgyline suggesting that MAO enzymes do not appear to be a significant binding target of any of them. These findings provide relevant insights for the correct interpretation of the in vivo behavior of these three tau PET tracers.

01 Mar 2024·Nuclear Medicine and Biology

In vitro evaluation of [3H]PI-2620 and structural derivatives in non-Alzheimer's tauopathies

Article

Author: Varlow, Cassis ; Vasdev, Neil ; Mathis, Chester A

Alzheimer's disease (AD) and non-AD tauopathies such as chronic traumatic encephalopathy (CTE), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD) are characterized by the abnormal aggregation of three-repeat (3R) and/or four-repeat (4R) tau isoforms. Several tau-PET tracers have been applied for human imaging of AD and non-AD tauopathies including [¹⁸F]PI-2620. Our objective is to evaluate [³H]PI-2620 and two promising structural derivatives, [³H]PI-2014 and [³H]F-4, using in vitro saturation assays and competitive binding assays against new chemical entities based on this scaffold in human AD tissues for comparison with PSP, CBD and CTE tissues. Thin section autoradiography was employed to assess specific binding and distribution of [³H]PI-2620 and [³H]F-4 in fresh-frozen human post-mortem AD, PSP, CBD and CTE tissues. Immunohistochemistry was performed for phospho-tau (AT8) and 4R-tau (RD4). Homogenate filtration binding assays were performed for saturation analysis and competitive binding studies against [³H]PI-2620. All compounds bound with high affinity in AD tissue. In PSP tissue [³H]PI-2620 demonstrated the highest affinity (5.3 nM) and in CBD tissue [³H]F-4 bound with the highest affinity (9.4 nM). Over 40 fluorinated derivatives based on PI-2620 and F-4 were screened in AD and PSP tissue. Notably, compound 2 was the most potent derivative in PSP tissue (K_i = 7.3 nM). By autoradiography, [³H]PI-2620 and [³H]F-4 demonstrated positive signals similar in intensity in AD, PSP and CTE tissues that were displaced by homologous blockade. Binding of both radiotracers aligned with immunostaining for 4R-tau. This work demonstrates that [³H]PI-2620 and [³H]F-4 show promise for imaging 4R-tau aggregates in non-AD tauopathies. PI-2620 continues to serve as a structural scaffold for PET radiotracers with higher affinity for non-AD tau over AD tau.

01 Jan 2024·Molecular Psychiatry

Correction: Discriminative binding of tau PET tracers PI2620, MK6240 and RO948 in Alzheimer’s disease, corticobasal degeneration and progressive supranuclear palsy brains

Author: Gillberg, Per-Göran ; Nordberg, Agneta ; Lemoine, Laëtitia ; Bogdanovic, Nenad ; Kumar, Amit ; Malarte, Mona-Lisa

Abstract: Recent mechanistic and structural studies have challenged the classical tauopathy classification approach and revealed the complexity and heterogeneity of tau pathol. in Alzheimer's disease (AD) and primary tauopathies such as corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP), progressing beyond distinct tau isoforms.In this multi-tau tracer study, we focused on the new second-generation tau PET tracers PI2620, MK6240 and RO948 to investigate this tau complexity in AD, CBD, and PSP brains using post-mortem radioligand binding studies and autoradiog. of large and small frozen brain sections.Saturation binding studies indicated multiple binding sites for 3H-PI2620 in AD, CBD and PSP brains with different binding affinities (Kd ranging from 0.2 to 0.7 nM) and binding site densities (following the order: BmaxAD > BmaxCBD > BmaxPSP).Competitive binding studies complemented these findings, demonstrating the presence of two binding sites [super-high affinity (SHA): IC50(1) = 8.1 pM; and high affinity (HA): IC50(2) = 4.9 nM] in AD brains.Regional binding distribution studies showed that 3H-PI2620 could discriminate between AD (n = 6) and control cases (n = 9), especially in frontal cortex and temporal cortex tissue (p < 0.001) as well as in the hippocampal region (p = 0.02).3H-PI2620, 3H-MK6240 and 3H-RO948 displayed similar binding behavior in AD brains (in both homogenate competitive studies and one large frozen hemispherical brain section autoradiog. studies) in terms of binding affinities, number of sites and regional patterns.Our small section autoradiog. studies in the frontal cortex of CBD (n = 3) and PSP brains (n = 2) showed high specificity for 3H-PI2620 but not for 3H-MK6240 or 3H-RO948.Our findings clearly demonstrate different binding properties among the second-generation tau PET tracers, which may assist in further understanding of tau heterogeneity in AD vs. non-AD tauopathies and suggests potential for development of pure selective 4R tau PET tracers.

News (Medical) associated with Izaflortaucipir (18F)

17 Sep 2024

·pipelinereview.com

AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s Disease

LAUSANNE, Switzerland I September 17, 2024 I AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced that it will receive the second ReTain-related milestone payment (CHF 24.6 million) under its agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. The milestone payment has been triggered by the rapid rate of prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030 (now called “JNJ-2056”) to treat preclinical (pre-symptomatic) Alzheimer’s disease (AD). With last December’s milestone payment, this brings the total milestone payments received for ACI-35.030 related to this trial to CHF 40 million. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “This early milestone demonstrates that the medical community and members of the public believe, as we do, that second generation therapeutics for Alzheimer’s disease, like our active immunotherapy targeting pathological phosphorylated-Tau protein (pTau), may provide an important benefit to those diagnosed early, prior to the development of disease symptoms. Early diagnosis and treatment are needed to combat neurodegeneration. “This payment also re-affirms the quality and productivity of AC Immune’s technology platforms and drug development capabilities. We have now received a total of approximately CHF 425 million in milestone and upfront payments from all of our collaboration deals to date, and there are outstanding potential milestone payments exceeding CHF 4.3 billion, plus royalties on potential sales. Importantly, in these challenging financial markets, this milestone payment adds to our already solid financial position, providing us with three years of cash for operations, in which time we expect to achieve several potentially transformational milestones.” JNJ-2056 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in July, an important recognition of its differentiation and its potential value for patients. It is the second active immunotherapy from AC Immune to achieve this regulatory milestone, after ACI-24.060, which targets Abeta. AC Immune’s PI-2620 Tau-PET diagnostic, which is in Phase 3 development, also received Fast Track designation this August. ACI-35.030 has been shown in Phase 1b/2a clinical testing to induce an antibody response targeting pTau while sparing normal endogenous forms of Tau. ReTain has attracted a high level of interest among potential participants with the rate of prescreening outperforming expectations. “The Phase 2b ReTain trial is a potentially important step in the fight against neurodegeneration, as it is the first time any active immunotherapy is being tested in the preclinical AD population. Active immunotherapies like ACI-35.030 could offer therapeutic advantages, together with improved convenience and access, and the recent Fast Track designation is an important recognition of its potential value for patients,” Dr. Pfeifer said. About the Phase 2b ReTain Study (ClinicalTrials.gov Identifier: NCT06544616 ) The Phase 2b ReTain trial is a potentially registration-enabling randomized, multicenter, double-blind, placebo-controlled clinical study in participants with preclinical AD to assess the clinical effect of active immunization with JNJ-64042056 (JNJ-2056). It is designed to test the hypothesis that JNJ-2056 has a disease-modifying effect that can delay or prevent the onset of cognitive impairment or other clinical symptoms in individuals with preclinical AD through inhibition of seeding and spreading of pathological Tau. The study will include approximately 500 participants with preclinical AD (cognitively normal, Tau positive), who will be randomized in a 1:1 ratio to a single dose level of JNJ-2056 or placebo and administered as intramuscular injections for a maximum of 4 years. It is currently being conducted at more than 40 clinical trial sites in the U.S., Japan, UK and Australia, and more are expected to open shortly. The primary endpoint will measure cognitive decline as assessed by the Preclinical AD Cognitive Composite 5 (PACC-5) score. The key secondary efficacy endpoint will assess the effect of JNJ-2056 on the propagation and/or accumulation of Tau pathology compared with placebo, as measured by Tau PET imaging. The ReTain trial is fully funded and conducted by Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, pursuant to a global license, development and commercialization agreement. About ACI-35.030 (JNJ-2056) ACI-35.030, derived from AC Immune’s SupraAntigen® platform, has been shown in clinical studies to induce a strong polyclonal antibody response that matures and is maintained against key pathological forms of Tau believed to drive Tau aggregation and disease progression. ACI-35.030 is designed to enhance the formation of broad-spectrum protective antibodies against pTau. This investigational candidate has the potential to reduce pathological Tau spreading in the early stages of AD, and thereby may reduce or prevent disease progression. About AC Immune SA AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties. SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU. SOURCE: AC Immune

Phase 2License out/inImmunotherapyFast Track

28 Aug 2024

·www.prnewswire.com

Life Molecular Imaging Receives FDA Fast Track Designation for [18F]PI-2620 in Tau PET Imaging Across Three Neurodegenerative Conditions

Fast Track Designation Granted for use in patients being evaluated for Alzheimer's Disease, Progressive Supranuclear Palsy, or Corticobasal Degeneration BOSTON, Aug. 28, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational PET imaging agent targeting tau neurofibrillary tangles. The Fast Track Designation has been granted for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). The FDA's Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the significant potential of [18F]PI-2620 to improve diagnosis of these three devastating neurodegenerative diseases. [18F]PI-2620 is a next-generation, F18-labeled PET imaging agent currently in Phase 3 clinical development for detecting tau pathology in Alzheimer's disease. The compound is also being investigated in other neurodegenerative diseases and settings by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD). The ability to accurately image tau pathology could significantly enhance disease diagnosis and patient care. "Receiving Fast Track Designation from the FDA is a major milestone that highlights the promise of [18F]PI-2620 in addressing the critical need for effective diagnostic tools in Alzheimer's disease, progressive supranuclear palsy, and corticobasal degeneration," said Andrew Stephens, Chief Medical Officer at LMI. "This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of [18F]PI-2620. We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible Tau PET imaging." About [18F]PI-2620 [18F]PI-2620 is an investigational PET imaging agent that was discovered and developed as part of a research collaboration between AC Immune and LMI. LMI has the exclusive, worldwide license for research, development and commercialization of Tau PET tracers generated within the discovery program. [18F]PI-2620 has demonstrated robust brain uptake and fast wash-out in non-target regions and excellent reproducibility between test and retest scans. The absence of significant off-target binding enables [18F]PI-2620 to detect and quantify early tau deposition in the brain. [18F]PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of tau deposits in the human brain including a Phase 3 image-to-autopsy study. [18F]PI-2620 also shows promise for detection of tau in non-AD tauopathies like progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: . For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 SOURCE Life Molecular Imaging

Phase 3License out/inFast Track

28 Aug 2024

·www.globenewswire.com

AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions

AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMIThis Fast Track designation applies across Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degenerationFollows two previous Fast Track designations for ACI-35.030 and ACI-24.060 active immunotherapiesAffirms AC Immune’s leadership and commitment to bringing precision medicine to the management of neurodegenerative diseases Lausanne, Switzerland, August 28, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced that its partner Life Molecular Imaging (LMI) has received Fast Track Designation for the Tau positron emission tomography (PET) diagnostic, [18F]PI-2620, from the U.S. Food and Drug Administration (FDA) in three neurodegenerative conditions. Fast Track designation for [18F]PI-2620 has been granted for clinical development in Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). The FDA’s Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the broadening view in the medical community that early and accurate diagnoses of neurodegenerative disease may lead to improved outcomes, thanks to emerging treatments. PI-2620 is a next-generation PET imaging agent currently in Phase 3 clinical development for detecting Tau pathology in Alzheimer's disease. The compound is also being investigated in other neurodegenerative diseases by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD), and accurately imaging the pathology could significantly enhance disease diagnosis and improve patient care. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “Fast Track designation for PI-2620 is an important reflection of its potential to accurately diagnose Alzheimer’s and other neurodegenerative diseases. Early diagnosis of these conditions will be key for effective treatment before irreversible damage occurs, and is an essential element in our goal of achieving precision prevention. The FDA has previously granted Fast Track status to two of our active immunotherapies in Phase 2 development, ACI-35.030 and ACI-24.060, which target phospho-Tau and Abeta, respectively. The designation for PI-2620 is a further recognition of AC Immune’s drug discovery and development platform and of how we, together with our partners, continue to drive innovation.” About PI-2620PI-2620 was discovered and developed as part of a research collaboration between AC Immune and LMI. LMI has the exclusive, worldwide license for research, development and commercialization of Tau-PET tracers generated within the discovery program. It has demonstrated robust brain uptake and fast wash-out in non-target regions, a broad imaging window between 30- and 90-minutes post-injection for AD, and excellent reproducibility between test and retest scans. The absence of significant off-target binding enables PI-2620 to detect and quantify early Tau deposition in the brain, a hallmark of neurodegenerative diseases. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain. PI-2620 also shows promise for non-AD tauopathies like progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS). About AC Immune SA AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties. SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release. For further information, please contact: SVP, Investor Relations & Corporate CommunicationsGary Waanders, Ph.D., MBAAC ImmunePhone: +41 21 345 91 91Email: gary.waanders@acimmune.comU.S. InvestorsCorey Davis, Ph.D.LifeSci AdvisorsPhone: +1 212 915 2577 Email: cdavis@lifesciadvisors.comInternational MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email: chris.maggos@cohesionbureau.com Forward looking statementsThis press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. Attachment 20240828_ACIU_PI-2620 FastTrack_Final_CLEAN

ImmunotherapyPhase 3Fast TrackPhase 2License out/in

100 Deals associated with Izaflortaucipir (18F)

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Indication	Highest Phase	Country/Location	Organization	Date
Brain Concussion	NDA/BLA	US	Life Molecular Imaging Ltd.	07 Jun 2021
Alzheimer Disease	Phase 3	US	Life Molecular Imaging Ltd.	01 Dec 2022
Cognitive Dysfunction	Phase 3	-	AC Immune SA	-
Cognitive Dysfunction	Phase 3	-	Piramal Pharma Limited	-
Mild cognitive disorder	Phase 2	KR	Asan Medical Center	09 Apr 2019
Supranuclear Palsy, Progressive	Phase 2	GB	-	24 Feb 2019
Frontotemporal Dementia	Phase 2	KR	Asan Medical Center	04 Jun 2018
Parkinson Disease	Phase 2	KR	Asan Medical Center	04 Jun 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2023	Not Applicable	-	-	18F-PI-2620 (Health Control (HC))	lybkynsvhc(mqaicdqleb) = 0 regions xggrxeuwhq (zmxvqtwwki ) View more	-	28 Aug 2023
				18F-PI-2620 (Alzheimer's Disease (AD))
SNMMI2023	Not Applicable	-	-	TAUVID[18F]PI-2620 ([18F]PI-2620)	jpuigqcdks(lhzbppvqwq) = gtbsoyuqni kliclffzvm (hlplilvhvm, 8)	-	28 Aug 2023
				[18F]T807TAUVID ([18F]T807)	jpuigqcdks(lhzbppvqwq) = jbcnoccqcf kliclffzvm (hlplilvhvm, 7)
SNMMI2023	Not Applicable	Frontotemporal Lobar Degeneration	-	[18F]PI-2620 (FTLD patients)	knelnmwwny(rtmeodzqku) = krvhiyexqb zpxorvyomg (wxzddzinqs )	-	28 Aug 2023
AAIC2017	Not Applicable	Alzheimer Disease \| Supranuclear Palsy, Progressive	-	18-F PI-2620 (Alzheimer's Disease)	cflmtyvenm(kmuiwlrzwo) = xmwmaqflmg oizswdpglw (jhqnjvlauj )	-	01 Jul 2017
				18-F PI-2620 (Progressive Supranuclear Palsy)	cflmtyvenm(kmuiwlrzwo) = gxvfjeylmf oizswdpglw (jhqnjvlauj )
SNMMI2017	Not Applicable	Alzheimer Disease	-	18-F PI-2620 (Mild Alzheimer's (AD))	axjaohxfwk(cpqhaygrzz) = SUVr time curves demonstrate a plateau at 90-100 min post injection with resultant SUVrs of 2.5-2.8 in abnormal regions vlpqztpimj (jwykuwiavy ) View more	-	24 May 2017
SNMMI2017	Not Applicable	Alzheimer Disease \| Tauopathies Tau aggregates	-	PI-2620	hynaljfgxj(xdcmudgffr) = yyozslejcp aglusmffqt (jninvxecca )	-	24 May 2017

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