A Double Blind, Randomized, Placebo-controlled, Multi-center, Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Mild and Moderate COVID-19

The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 150 mg versus placebo once daily administration with standard of care therapy for 10 days in patients with mild and moderate COVID-19.

Start Date19 Mar 2021

Sponsor / Collaborator

Bukwang Pharmaceutical Co., Ltd.

NCT04347915 / CompletedPhase 2

A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19

The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate COVID-19.

Start Date26 May 2020

Sponsor / Collaborator

Bukwang Pharmaceutical Co., Ltd.

NCT01581242 / CompletedPhase 1

A Randomized, Open-label, Three-sequence, Three-period, Three-treatment Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects

This is a randomized, open-label, three-sequence, three-period, three-treatment clinical trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir dipivoxil after oral administration in healthy male subjects.

Start Date01 Apr 2012

Sponsor / Collaborator

Bukwang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Clevudine

100 Translational Medicine associated with Clevudine

100 Patents (Medical) associated with Clevudine

145

Literatures (Medical) associated with Clevudine

01 Jan 2023·Journal of viral hepatitis

A randomized phase 1b trial of the active site polymerase inhibitor nucleotide ATI‐2173 in patients with chronic hepatitis B virus infection

Article

Author: Squires, Katherine E. ; Huguet, Jade ; Anastasiy, Igor ; Melara, Rebeca ; De La Rosa, Abel ; Ghicavii, Nelli ; Jucov, Alina ; Constantineau, Martin ; Ogilvie, Lauren ; Mayers, Douglas L.

Abstract:

ATI‐2173 is an active site polymerase inhibitor nucleotide in development as part of a potentially curative regimen for chronic hepatitis B virus (HBV) infection. This study evaluated the safety, tolerability, pharmacokinetics (PK) and antiviral activity of ATI‐2173. This was a phase 1b, randomized, double‐blind, placebo‐controlled trial in treatment‐naive adults with chronic HBV infection conducted in the Republic of Moldova and Ukraine (ClinicalTrials.gov: NCT04248426). Patients positive for hepatitis B surface antigen were randomized 6:2 to receive once‐daily oral doses of ATI‐2173 10, 25, or 50 mg (n = 6 per dose) or placebo (n = 7) for 28 days, with off‐treatment monitoring for 24 weeks. Endpoints included PK parameters of ATI‐2173 and its metabolite clevudine, maximum reduction from baseline in HBV DNA, and safety and tolerability. Treatment‐emergent adverse events occurred in eight patients (47%) receiving ATI‐2173 and five (71%) receiving placebo; headache was the most common (n = 4). ATI‐2173 PK was generally dose proportional. Systemic clevudine exposure with ATI‐2173 dosing was substantially reduced compared with historical values observed with clevudine administration. On Day 28, mean changes from baseline in HBV DNA were −2.72 to −2.78 log10 IU/ml with ATI‐2173 and +0.17 log10 IU/ml with placebo. Off‐treatment sustained viral suppression and decreases in covalently closed circular DNA biomarkers were observed in most patients; one maintained undetectable HBV DNA at 24 weeks off treatment. In this 28‐day monotherapy study, ATI‐2173 demonstrated safety and antiviral activity, with sustained off‐treatment effects and substantially reduced systemic clevudine exposure. These results support evaluation of ATI‐2173 with tenofovir disoproxil fumarate in phase 2 studies.

01 Jan 2022·Antiviral chemistry & chemotherapy

Active site polymerase inhibitor nucleotides (ASPINs): Potential agents for chronic HBV cure regimens

Review

Author: Squires, Katherine ; Gish, Robert G ; Asselah, Tarik ; Mayers, Douglas

Chronic hepatitis B virus (HBV) infection affects 240 to 300 million people worldwide. In the nucleus of infected hepatocytes, the HBV genome is converted to covalently closed circular DNA (cccDNA), which persists and serves as a transcriptional template for viral progeny. Therefore, a long-term cure for chronic HBV infection will require elimination of cccDNA. Although currently available nucleos(t)ide analogues (eg, tenofovir disoproxil fumarate, tenofovir alafenamide, entecavir) effectively control HBV replication, they are seldom curative (functional cure rate ∼10%) and require lifelong treatment for most patients. As such, antiviral agents with novel mechanisms of action are needed. Active site polymerase inhibitor nucleotides (ASPINs) noncompetitively distort the HBV polymerase active site to completely inhibit all polymerase functions, unlike traditional chain-terminating nucleos(t)ide analogues, which only target select polymerase functions and are consumed in the process. Clevudine, a first-generation ASPIN, demonstrated potent and prolonged HBV suppression in phase 2 and 3 clinical studies, but long-term treatment was associated with reversible myopathy in a small number of patients. ATI-2173, a novel next-generation ASPIN, is structurally similar to clevudine but targets the liver and demonstrates potent anti-HBV activity on and off treatment, and may ultimately demonstrate an improved pharmacokinetic and safety profile by significantly reducing systemic clevudine exposure. Thus, ATI-2173 is currently in clinical development as an agent for HBV cure. Here, we review the mechanism of action and preclinical and clinical profiles of clevudine and ATI-2173 to support the role of ASPINs as part of curative regimens for chronic HBV infection.

01 Dec 2021·International immunopharmacologyQ2 · MEDICINE

Clevudine attenuates bleomycin-induced early pulmonary fibrosis via regulating M2 macrophage polarization

Q2 · MEDICINE

Article

Author: Ruan, Hao ; Liang, Qing ; Zhou, Honggang ; Li, Xiaoping ; Li, Xiaohe ; Yang, Cheng ; Jiang, Qiuyan ; Zhang, Ruiqin ; Gao, Shaoyan ; Zhang, Fangxia ; Li, Shuangling ; Luan, Jiaoyan

Pulmonary fibrosis (IPF) is a chronic, progressive interstitial lung disease. It is a growing clinical problem which can result in breathlessness or respiratory failure and has an average life expectancy of 3 years from diagnosis. Predominantly accumulation of M2 macrophages accelerates fibrosis progression by secreting multiple cytokines that promote fibroblast to myofibroblast transition and aberrant wound healing of epithelial cells. Targeting activated macrophages to inhibit the pro-fibrotic phenotype is considered as an approach for the potential treatment of PF. Clevudine is s a purine nucleoside analogue which in an oral formulation is approved for treatment of patients with hepatitis B virus (HBV). Here, we found that clevudine is capable of suppressing pro-fibrotic phenotype (i.e., CD206, Arg1 and YM1) of M2 macrophages while enhancing anti-fibrotic phenotype (i.e., CD86, IL-6 and IL-10) by inhibiting PI3K/Akt signaling pathway. This effect further alleviates M2-induced myofibroblast activation and epithelial-to-mesenchymal transition (EMT), thus resulting in a decline of collagen deposition, pro-fibrotic cytokines secretion, with a concomitant recover ofpulmonary functions in vivo. Less infiltration of M2 macrophages between α-SMA + cells was also found in clevudine treated mice. Our findings indicate a potential anti-fibrotic effect of clevudine by regulating macrophage polarization and might be meaningful in clinical settings.

News (Medical) associated with Clevudine

25 Jun 2022

·www.prnewswire.com

Antios Therapeutics' ATI-2173 Demonstrates Suppression of Hepatitis B Virus in Phase 2a Study; ATI-1428 and ATI-1645 Exhibit Potent Antiviral Activity in a Nonclinical Study

New data presented in two separate oral presentations at the European Association for the Study of the Liver's International Liver Congress 2022 (EASL ILC 2022) Following 90 days of dosing, ATI-2173, in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated with alanine aminotransferase (ALT) normalization and no ALT flares off-treatment Antios' capsid assembly modulators (CAMs) ATI-1428 and ATI-1645 show safe and potent in vitro and in vivo activity and excellent pharmacokinetic profiles DOYLESTOWN, Pa., June 25, 2022 /PRNewswire/ -- Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing transformative treatments for hepatitis B virus (HBV), today announced new data from the Phase 2a clinical trial of ATI-2173, its lead investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. Antios also announced new data on its 4th generation capsid assembly modulator (CAM) program evaluating ATI-1428 and ATI-1645. In the 90-day Phase 2a trial, adult patients receiving ATI-2173 in combination with tenofovir disoproxil fumarate (TDF) showed slower virologic rebound than patients receiving TDF plus placebo after stopping treatment. Additionally, in a nonclinical study, low oral doses of ATI-1428 and ATI-1645 given once-daily blocked hepatic HBV replication and reduced both serum HBV DNA and RNA to undetectable levels. These data were presented at the European Association for the Study of the Liver's International Liver Congress 2022 (EASL ILC 2022). Highlights from the EASL Oral Presentation on ATI-2173 In the 90-day Phase 2a study, at 24 weeks off-treatment, 75% (n=16) of ATI-2173 plus TDF patients did not meet criteria to restart TDF treatment vs. 0% (n=4) in the TDF alone arm In the ATI-2173 plus TDF arms (n=16), alanine aminotransferase (ALT) levels normalized on-treatment and no patients receiving ATI-2173 plus TDF experienced ALT flares during the 24-week off-treatment follow-up period All patients completed 90 days of dosing with no serious adverse events or dose-limiting toxicities "These data reinforce our belief that ATI-2173 can act as a bridge on the path to an HBV cure, with the potential to provide a meaningful clinical benefit to patients," said Douglas Mayers, M.D., Chief Medical Officer, and Co-Founder of Antios. "The slower virological rebound, ALT normalization on-treatment and no off-treatment ALT flares among those on the ATI-2173 combination regimen highlight the promise of the ASPIN mechanism of action – which we believe can be complementary to all other approaches." Highlights from the EASL Oral Presentation on ATI-1428 and ATI-1645 ATI-1428 and ATI-1645 are 4th generation class II CAMs with a novel and unique ultra-potent mechanism of action designed to provide for a more targeted and beneficial antiviral response with an improved clinical safety profile due to the lack of HBV capsid accumulation in liver cells ATI-1428 and ATI-1645 have displayed strong nonclinical antiviral activity in a mouse model against the various HBV genotypes and low EC50 shift against naturally occurring variants associated with resistance to past and current CAMs In in vivo mouse experiments, ATI-1428 or ATI-1645 blocked HBV replication in the liver of immunocompetent HBV-replicating mice and prevented unnecessary T-cell mediated liver damage through non-accumulation/degradation of empty capsids in the hepatocyte Both compounds show safe and potent in vitro and in vivo activity and excellent pharmacokinetic profiles "The nonclinical data supports our view that clinical development of 4th generation CAM compounds has the potential to provide a safe and effective approach for treating HBV," said Luca Guidotti, M.D., Ph.D., Deputy Scientific Director of San Raffaele Hospital and Scientific Advisor to Antios. "By preventing the abnormal capsid accumulation that less potent CAMs induce, these ultra-potent CAMs are designed to not sensitize hepatocytes to unnecessary T cell-mediated killing. This may allow the development of safe and effective combinations with therapeutic strategies aimed at immune reactivation." These presentations can be found on the Antios website at . About ATI-2173 ATI-2173, Antios Therapeutics' lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to be a bridge to a potential cure for HBV. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure. About ATI-1428 and ATI-1645 ATI-1428 and ATI-1645 are 4th generation, class II capsid assembly modulators (CAMs) both with a novel and unique ultra-potent mechanism of action design that may provide for a safer and more productive interaction with the immune system. Derived from a novel chemical scaffold, these CAMs have shown strong in vitro and in vivo activity in a transgenic mouse model of HBV infection. As CAMs with an ultrapotent design preclinically inducing no abnormal accumulation of empty capsids based on an initial preclinical mouse study, ATI-1428 and ATI-1645 represent promising candidates for clinical development and have entered investigational new drug enabling development. ATI-1428 and ATI-1645 were acquired by Antios in November of 2021 from San Raffaele Hospital (OSR), Istituto Nazionale Genetica Molecolare (INGM), and IRBM/Promidis, a collaboration of Italian research institutes and a global contract research organization. About HBV Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection, which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that up to 300 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately two million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options. About Antios Therapeutics, Inc. Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Its lead drug candidate ATI-2173 – the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development – has the potential, if approved, to become a potential bridge to a cure for chronic HBV. Antios is also developing a novel series of 4th generation Class II capsid assembly modulators (CAMs) to further expand Antios' portfolio of differentiated molecules that could lead to a cure for HBV. HBV is a major unmet global health problem affecting up to 300 million people worldwide, more than hepatitis C and HIV combined. For more information, please visit . SOURCE Antios Therapeutics

Vaccine

08 Jun 2022

·www.prnewswire.com

Antios Therapeutics Announces Oral Presentations on ATI-2173, ATI-1428, and ATI-1645 Hepatitis B Virus Programs at the EASL International Liver Congress™ 2022

DOYLESTOWN, Pa., June 8, 2022 /PRNewswire/ -- Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to advance treatments that can provide a bridge to a cure for chronic hepatitis B virus (HBV), today announced the acceptance of oral presentations highlighting ATI-2173, Antios' lead therapeutic HBV candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and ATI-1428 and ATI-1645, candidates from Antios' 4th generation capsid assembly modulators (CAM) program. These presentations will be given at the European Association for the Study of the Liver's International Liver Congress 2022 (EASL ILC 2022), taking place June 22 – 26, 2022 at the ExCeL London Exhibition Centre in London, UK. Antios will be presenting the 90-day, Phase 2a study of ATI-2173 in combination with tenofovir disoproxil fumarate (TDF). This double-blind, randomized, placebo-controlled study of 20 adult patients was designed to assess the efficacy and safety of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with TDF compared with TDF plus placebo (control) in chronic HBV-infected subjects. The primary endpoints included the percentage of patients experiencing adverse reactions and time to HBV viral load relapse. In addition to adverse reactions, as a part of the primary safety endpoint, the safety evaluations recorded off-treatment ALT flares in all treatment groups. Antios will also present preclinical data from ATI-1428 and ATI-1645, which are in investigational new drug enabling development. These candidates are class II CAMs with a novel and unique ultra-potent mechanism of action design that may provide for a more targeted and beneficial antiviral response by the immune system. To date, data in a transgenic mouse model for both compounds provide initial evidence for potent in vitro and in vivo activity, an excellent pharmacokinetic profile, and no accumulation of empty capsids in the hepatocellular cytoplasm. "We see ATI-2173 as a bridge to a cure – an important first step in the ultimate search for a cure for HBV," said Greg Mayes, Chief Executive Officer of Antios. "To date, the data have been encouraging, indicating that combining ATI-2173 with a nucleoside analogue such as TDF in a simple, once-a-day regimen has the potential to completely shut down HBV polymerase activity and viral replication. We look forward to presenting our Phase 2a data, as well as the initial data from our CAM program, at the upcoming International Liver Congress." Antios Therapeutics EASL ILC 2022 Presentation Details: Title: Sustained 12-week off treatment antiviral efficacy of ATI-2173, a novel active site polymerase inhibitor nucleotide, combined with tenofovir disoproxil fumarate in chronic hepatitis B patients, a phase 2a clinical trial (#296) Author/Presenter: Douglas Mayers, M.D. Presentation Type: Oral Presentation Date/Time: June 25, 2022, at 9:15am BST Title: Novel ultra-potent capsid assembly modulators prevent abnormal accumulation of empty capsids and associated T-cell mediated liver injury in a mouse model of hepatitis B virus infection (#291) Author/Presenter: Luca Guidotti, M.D., Ph.D. Presentation Type: Oral Presentation Date/Time: June 25, 2022, at 5:30pm BST About ATI-2173 ATI-2173, Antios Therapeutics' lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to be a bridge to a potential cure for HBV. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure. About ATI-1428 and ATI-1645 ATI-1428 and ATI-1645 are 4th generation, class II capsid assembly modulators (CAMs), both with a novel and unique ultra-potent mechanism of action design that may provide for a more targeted, productive antiviral response by the immune system. Derived from a novel chemical scaffold, these CAMs have shown strong in vitro and in vivo activity in a transgenic mouse model of HBV infection. As CAMs with an ultrapotent design inducing no accumulation of empty capsids based on an initial preclinical mouse study, ATI-1428 and ATI-1645 represent promising candidates for clinical development and have entered investigational new drug enabling development. ATI-1428 and ATI-1645 were acquired by Antios in November of 2021 from San Raffaele Hospital (OSR), Istituto Nazionale Genetica Molecolare (INGM), and IRBM/Promidis, a collaboration of Italian research institutes and a global contract research organization. About HBV Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection, which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that up to 300 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately two million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options. About Antios Therapeutics, Inc. Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Its lead drug candidate ATI-2173 – the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development – has the potential, if approved, to become a potential bridge to a cure for chronic HBV. Antios is also developing a novel series of 4th generation capsid assembly modulators (CAMs) to further expand Antios' portfolio of differentiated molecules in the HBV space. HBV is a major unmet global health problem affecting up to 300 million people worldwide, more than hepatitis C and HIV combined. For more information, please visit . SOURCE Antios Therapeutics

Vaccine

03 Nov 2021

·endpts.com

Antios Therapeutics' hep B candidate gets another round of applause from investors, closing out a $171M megaround

Antios Therapeutics, the Atlanta biotech that was the brainchild of former hep C pioneer Pharmasset executive and former Antios CEO Abel De La Rosa, announced this morning that the biotech raised $75 million in a Series B-1, ending the firm’s Series B round. After the biotech threw its hat into the hepatitis B ring three years ago with $25 million from a Series A, Antios then raised $96 million from a Series B in April to push their lead candidate — an active site polymerase inhibitor nucleotide, or ASPIN known as ATI-2173 — through Phase II. The latest $75 million round brings the company’s Series B up to $171 million. This financing round, co-led by young investment firm GordonMD Global Investments, will help push Antios’ lead candidate — in testing by itself and with tenofovir — to a Phase IIb trial to start next year. Other investors included RA Capital, LifeSci Venture Partners and Lumira Ventures. Back in April, ATI-2173 was in a Phase IIa study in combination with approved HBV antiviral tenofovir. And according to Antios CEO Greg Mayes, the Phase IIb trial will start sometime in the second half of 2022. “We would expect to complete the Phase IIb program in 2024,” Mayes told Endpoints News. Antios’ candidate is derived from an old Pharmasset drug called clevudine — which started out at Bukwang Pharmaceuticals before being licensed to Triangle in 1998. After buying out Triangle in 2003, Gilead transferred the rights back to Bukwang, which then licensed the drug to Pharmasset in 2005. “We are pleased to add GordonMD Global Investments to our existing group of high-caliber healthcare investors,” Mayes said in a prepared statement. “This round of investment enables us to accelerate the Phase IIb clinical development of ATI-2173.” In their press release, Antios also announced that GordonMD’s founder and CEO Craig Gordon will join Antios’ board of directors. “We believe in the mission that Antios’ management and clinical teams are driving forward and are excited to be a part of their next phase of growth,” said GordonMD founder and CEO Craig Gordon in a statement.

100 Deals associated with Clevudine

External Link

KEGG	Wiki	ATC	Drug Bank
D03537	Clevudine	J05AF12	DB06683

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	KR	Bukwang Pharmaceutical Co., Ltd.	13 Jun 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Persistent Polyclonal B-Cell Lymphocytosis	Phase 3	KR	Bukwang Pharmaceutical Co., Ltd.	01 Dec 2007
Hepatitis, Chronic	Phase 3	US	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	CN	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	AR	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	AU	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	BR	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	CA	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	GR	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	PR	Pharmasset, Inc.	01 Aug 2007
Hepatitis, Chronic	Phase 3	ES	Pharmasset, Inc.	01 Aug 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2014	Not Applicable	Hepatitis B, Chronic hypertension \| diabetes \| history of liver or kidney transplantation ... View more	4,178	Lamivudine	bihweadqct(dwqnbxwbod) = ututkarwpj tdkbptmoeg (zedaukqamt )	-	11 Nov 2014
				Clevudine	bihweadqct(dwqnbxwbod) = opnddvqnap tdkbptmoeg (zedaukqamt )
NCT00313274 (Pubmed \| Hepatology)	Phase 3	Hepatitis B, Chronic	86	Clevudine 30 mg	jkadrlegvq(dhtxjhwlxa) = ichhrkjmoj iahdzduhqc (uecelwidjp ) View more	-	01 Oct 2007
				Placebo	jkadrlegvq(dhtxjhwlxa) = llbkhrgbtf iahdzduhqc (uecelwidjp ) View more

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