A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 Over 52 Weeks in Participants with Early Alzheimer's Disease (Polaris-AD)

This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.

Start Date23 Dec 2022

Sponsor / Collaborator

ARIBIO Co., Ltd.

NCT03625622 / CompletedPhase 2

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.

Start Date01 Apr 2019

Sponsor / Collaborator

ARIBIO Co., Ltd.

CTR20244348 / Not yet recruitingPhase 3

一项评价AR1001治疗早期阿尔茨海默病受试者持续52周的有效性和安全性的III期、双盲、随机、安慰剂对照、多中心试验

[Translation] A Phase III, double-blind, randomized, placebo-controlled, multicenter trial evaluating the efficacy and safety of AR1001 in subjects with early Alzheimer's disease for 52 weeks

评价AR1001与安慰剂相比在早期阿尔茨海默病受试者中的有效性

[Translation]

To evaluate the efficacy of AR1001 compared with placebo in subjects with early Alzheimer's disease

Start Date-

Sponsor / Collaborator

Bonacia (Hefei) Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Mirodenafil dihydrochloride

100 Translational Medicine associated with Mirodenafil dihydrochloride

100 Patents (Medical) associated with Mirodenafil dihydrochloride

Literatures (Medical) associated with Mirodenafil dihydrochloride

01 Dec 2023·Alzheimers & Dementia

Protective Effects of AR1001 in Alzheimer’s Disease Models: Polypharmacological Mechanisms

Article

Author: Choung, Jai Jun ; Kumar, Ashish ; Kang, Byung Woo ; Ha, Jae‐Young ; Song, Dong‐Keun

Abstract:

Background:

Nitric oxide/cGMP/CREB signaling is critical for learning and memory processes and is disturbed by Abeta amyoid and in Alzheimer’s disease. AR1001 is an inhibitor of phosphodiesterase (PDE)‐5, which degrades specifically cGMP, thus having a potential to reverse AD pathology.

Method:

For the in vivo study, AR1001 was intraperitoneally administered (4 mg/kg/day) to APP‐C105 mice for 4 weeks. Then after behavioral tests (Morris‐water maze and passive avoidance tests) were done, hippocampal levels of Abeta1‐42 and p‐Tau (S199/202) were determined. In the in vitro study using human neuroblastoma SH‐SY5Y cells and mouse hippocampal HT‐22 cells, the effects of AR1001 on Abeta1‐42‐induced cytotoxicity and intracellular signaling were examined.

Result:

AR1001 markedly improved cognitive functions in both Morris‐water maze and passive avoidance tests and reduced hippocampal Abeta1‐42 and p‐Tau levels in the APP‐C105 mice. In the in vitro experiments, AR1001 inhibited Abeta1‐42‐induced cell death, mitochondrial membrane potential derangement, and apoptotic markers (cleaved caspase‐3 and cleaved PPAR) concentration‐dependently. AR1001 reversed Abeta1‐42‐induced decrease in phosphorylated CREB (p‐CREB), and NGF/BDNF expression. Further, AR1001 blocked Abeta1‐42‐induced pSer9‐GSK3beta decrease and p25/p35 increase. Interestingly, compared with sildenafil, vardenafil and tadalafil, AR1001 was more effective in inhibiting glucocorticoid receptor (GR) dimerization and Wnt antagonist Dickkopf‐1 (Dkk‐1) expression, and in enhancing Wnt3a expression.

Conclusion:

AR1001 had protective effects both in vivo and in vitro models of AD. Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE‐5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).

01 Feb 2007·Current opinion in investigational drugs (London, England : 2000)

Valopicitabine dihydrochloride:a specific polymerase inhibitor of hepatitis C virus.

Review

Author: Toniutto, Pierluigi ; Fabris, Carlo ; Pirisi, Mario ; Bitetto, Davide ; Rapetti, Rachele ; Fornasiere, Ezio

Idenix Pharmaceuticals Inc and Novartis AG are codeveloping valopicitabine dihydrochloride, a once-daily oral nucleoside for the potential treatment of HCV infection. In January 2005, a phase IIa clinical trial comparing valopicitabine dihydrochloride with pegylated IFN in treatment-naive HCV patients was ongoing, in addition to a phase IIb trial in patients that had previously failed pegylated IFN and ribavirin combination therapy. In January 2006, an international phase III trial in treatment-refractory patients was planned for the first half of the year, with a phase III trial in treatment-naive individuals planned for the second half of the year.

01 Jan 1995·Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine

The Effect of a New Expectorant Drug on Mucus Transport in Chronic Bronchitis

Article

Author: Santolicandro, A ; Baldi, S ; Giuntini, C

The expectorant effect of two weeks treatment with cistinexine dihydrochloride (Rec 15/1884/2, Recordati S.p.A, Milano), on mucus transport rate (MTR) was evaluated in a double-blind study on 30 chronic bronchitis patients, 20 treated with active drug (group D), 10 with placebo (group P). After inhalation of nebulized 99mTc labelled human albumin minimicrospheres (HAMM), MTR was determined by external gamma-camera counting over the thorax. To control initial particle deposition a penetration index (PI) was determined as the ratio of activity between peripheral and hilar regions of equal size. Before treatment no differences were found between groups in spirometry, PI, and MTR. After treatment spirometry and PI remained unchanged in both groups. MTR expressed as the half time (T1/2) of the exponential fitting between 0 and 40 minutes showed an interesting behaviour, particularly in group D. Considering the group as a whole, T1/2 did not vary significantly (381 +/- 400 min. before, vs 224 +/- 132 min. after treatment, p = 0.090). However, a statistically significant reduction of the index (815 +/- 396 min. before vs. 258 +/- 120 min. after treatment, p < 0.01) occurred in the seven patients showing at baseline a T1/2 higher than 338 +/- 182 min. (the reference value observed in our laboratory for 8 asymptomatic non smoker subjects). Therefore, the beneficial effect of the drug is seen only in patients with a severe impairment of MTR.

News (Medical) associated with Mirodenafil dihydrochloride

15 Oct 2024

·www.prnewswire.com

Neurophet-AriBio to develop 'Next-Gen Platform for Alzheimer's diagnosis'

- Neurophet's brain MRI analysis technology incorporates fluid biomarker data from AriBio's global Phase 3 clinical trial for Alzheimer's disease - Collaborates leveraging Neurophet's medical image analysis technology and AriBio's clinical trial data analysis expertise SEOUL, South Korea, Oct. 15, 2024 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced its collaboration with AriBio, a biopharmaceutical company developing therapies for neurodegenerative diseases, to develop next-generation platform for Alzheimer's diagnosis. Continue Reading Neurophet-AriBio to develop ‘Next-Gen Platform for Alzheimer's diagnosis’ The collaboration aims to develop a new Alzheimer's diagnostic platform by integrating Neurophet's brain image analysis technology using MRI (magnetic resonance imaging) with fluid biomarker data from AriBio's global Phase 3 clinical trial for early Alzheimer's disease. AriBio's platform team with clinical trial data analytics capabilities will collaborate with Neurophet's AI team on developing this advanced diagnostic platform. The conventional method to diagnosing Alzheimer's disease typically involves amyloid-PET (positron emission tomography) scan or CSF (cerebrospinal fluid) test to detect cortical amyloid beta deposition and confirm the presence of Alzheimer's. However, amyloid-PET scans are relatively expensive, and the CSF test involves a lumbar puncture, where a long needle is inserted between the vertebrae to drain fluid, which causes pain and requires time for recovery. These limitations result in lower medical accessibility for patients. To address these challenges, Neurophet and AriBio are developing a new diagnostic platform. The plan is to create a platform that can predict the risk of amyloid beta protein positivity early by conducting MRI analysis and blood-based biomarker tests before amyloid-PET scans. This approach aims to reduce unnecessary amyloid-PET scans and actively utilize a more accessible Alzheimer's disease testing method. "By participating in AriBio's global Phase 3 clinical trial of AR1001, a broad range of medical data will be obtained to achieve meaningful research outcomes in various fields." said Jake Junkil Been, CEO of Neurophet. "If this platform is successfully developed, it could significantly reduce medical costs associated with dementia diagnosis and treatment, while also improving patient convenience." Jai Jun Choung, CEO of AriBio stated, "AriBio is working on a safe and easy-to-take oral tablet to ensure accessibility and convenience for Alzheimer's disease patients and their families, and we hope to further enhance diagnostic accessibility through our collaboration with Neurophet." Neurophet has entered into an agreement with AriBio to participate in the global phase 3 clinical trial of AR1001, an oral treatment for Alzheimer's disease. Neurophet plays a key role in identifying eligible patients for the trial and assessing the treatment effect of AR1001 using its brain imaging analysis technology. In addition, the two companies are conducting joint research and business development by utilizing the medical image, blood, and CSF data obtained from the large-scale, multinational AR1001 clinical trials. About Neurophet Neurophet has specialized in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain diseases based on cutting-edge artificial intelligence (AI) technology. The company was founded in 2016 by Jake Junkil Been, CEO, and Donghyeon Kim, CTO, who developed the next-generation neuro-navigation system. Major products include brain MRI analysis software "Neurophet AQUA", brain PET image analysis (PET tracer deposition) software "Neurophet SCALE PET", brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet tES/TMS LAB". Neurophet has set its top priority to helping patients suffering from brain diseases. Based on expertise in neuroscience, Neurophet will continue to challenge and grow to explore the human brain's health and pioneer solutions for brain diseases with AI technology. SOURCE Neurophet WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

04 Oct 2024

·www.mobihealthnews.com

Indian mental health app Lissun takes on AI with $3M and more briefs

Mental health app Lissun bags $3M for AI integration Mental health platform Lissun in India has scored $2.5 million in a pre-Series A funding round led by RPSG Capital Ventures. With its fresh funds, the startup plans to integrate AI into its suite of digital mental health solutions which target corporates, schools, and families of children with neurodevelopmental conditions. The new funds will also go to expanding their services and growing their team. Proceeds from this new investing round bring its total investment to $5 million. Lissun last raised over $1 million in seed funding in September of the previous year. Asan Medical Center first to prescribe locally-approved vision loss DTx Asan Medical Center (AMC), one of South Korea's biggest hospitals, has started prescribing a Korean-made digital therapeutic for visual impairment due to stroke. The mobile-based application Vivid Brain provides training through virtual reality to enhance a user's response to visual stimuli. AMC officially prescribed the solution in September, five months after it was cleared by the Korean government – the third for a local DTx. AMC professor Kang Dong-hwa, who developed Vivid Brain with Nunaps (a local company he founded), now plans to expand their DTx to hospitals locally and abroad. Neurophet's latest collab to predict Alzheimer's risk Korean medical imaging AI company Neurophet has announced a new partnership that will develop a new Alzheimer's disease diagnosis platform. In a statement, the company said it will collaborate with local biotechnology firm Aribio, which develops treatment for neurodegenerative diseases. They intend to integrate Neurophet's MRI-based image analysis software with Aribio's blood-based Alzheimer's diagnostic test to detect early people with Alzheimer's-positive amyloid beta protein deposits in their brains. Their solution, according to a press release, seeks to make Alzheimer's testing more accessible, reducing repeat testing with the costly amyloid-PET imaging. Neurophet and Aribio's collaboration builds on their existing work in the global clinical trial of Aribio's oral Alzheimer's treatment AR1001, phase 3. In July, Neurophet unveiled the Neurophet AQUA AD, its latest Alzheimer's treatment prescription and monitoring software.

Drug Approval

30 Sep 2024

·www.globenewswire.com

Adaptive Research Announces it has Begun Enrolling Patients in AriBio’s Phase 3 POLARIS-AD Clinical Trial

SAN FRANCISCO, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Adaptive Research, a clinical trial site organization whose mission is to democratize clinical trials by providing full-service support to trial investigators in community settings, announced two community practices that are part of the Adaptive Research network have begun patient enrollment and randomization in AriBio’s Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (POLARIS-AD). Noor Sachdev, MD and Perminder Bhatia, MD will serve as investigators with regulatory, finance, and clinical support for all study-related activities provided by Adaptive Research. “Studies such as this—which require participants to have signs and symptoms associated with the early stage of Alzheimer’s, such as some memory, planning, and organizational issues, and have a care partner who can accompany them to study visits—demonstrate the value of including community sites,” said Deepak Behera, MD, President and Chief Executive Officer of Adaptive Research. “Travel time to academic settings can contribute to inequalities in Alzheimer's disease clinical trial enrollment due to age, geography, and ethnicity. To recruit study populations that reflect the treatment population and make it easier for them to stay in the study, Sponsors need sites closer to patients that can produce quality data. In fact, community sites tend to know the patient population better resulting in a lower screen fail rate and better patient retainment compared to other settings.” “As we engage with interested investigators and sites across the world who are committed to making a difference in the treatment of patients with Alzheimer’s disease, we are pleased to have access to these community physicians who are on the front lines of patient care and often the first to see patients with early AD. These sites are paramount to running successful trials and providing access to diverse populations,” said James Rock, Chief Clinical Officer for AriBio. AriBio previously completed a Phase 2 study (NCT03625622) with AR1001 in a mild to moderate AD population in the US. AriBio is expected to enroll 1150 participants in this global Phase 3 clinical trial to evaluate the therapeutic potential of AR1001 in the treatment of early Alzheimer’s disease. About AR1001 About AR1001-ADP3-US01 AR1001-ADP3-US01 (NCT05531526) is Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer's disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05531526). About Adaptive Research Founded in 2020, Adaptive Research Inc. is revolutionizing the landscape of clinical trials. By offering full-service support to trial investigators, Adaptive Research connects Sponsors of potential life-saving investigational agents and medical devices with community physicians and their patients nationwide. Adaptive Research’s expert team functions as a virtual clinical trials office, managing administrative and regulatory responsibilities, and enabling physicians to focus on their paramount task: providing exceptional clinical judgement and care. For additional information, visit https://adaptiveresearch.com. About AriBio AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease. Contacts:Inquiriesyour.partner@adaptiveresearch.com

Phase 2Phase 3

100 Deals associated with Mirodenafil dihydrochloride

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	US	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	CZ	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	DK	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	FR	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	DE	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	IT	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	NL	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	KR	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	ES	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	GB	ARIBIO Co., Ltd.	23 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03625622 (BusinessWire) Manual	Phase 2	Alzheimer Disease	210	AR1001 10 mg	soandojrpt(aavzlmqkwd) = tfkczqzvuh yephjkrbja (xncnrsdieu )	Positive	04 Nov 2021
				AR1001 30 mg	zlgpfifztp(nfrsuuzhht) = psxzwoxiik kfnreuwakq (ejxtevgues ) View more

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