A Phase II, Multi-centre Open Label Study to Assess the Efficacy and Safety of Oral Apabetalone with Background Dapagliflozin in Subjects with Long -COVID-19 (Post-COVID-19 Conditions) and Type 2 Diabetes Mellitus (T2DM)

This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.

Start Date30 Nov 2024

Sponsor / Collaborator

Resverlogix Corp.

NCT03160430 / Not yet recruitingPhase 1/2

A Two-Part Phase 2a Study in Patients With End-Stage Renal Disease Treated With Hemodialysis; Part A is an Open-Label Study Arm to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of 100 mg RVX000222; and Part B is a Double-Blind, Randomized, Placebo-Controlled, Sequential Cross-Over Study Arm to Evaluate the Efficacy, Safety, and Pharmacokinetics of RVX000222

This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care.
Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC.
The primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.

Start Date22 Nov 2024

Sponsor / Collaborator

Resverlogix Corp.

NCT04915300 / Not yet recruitingPhase 2

Apabetalone for Pulmonary Arterial Hypertension: a Phase 2 Clinical Study

Throughout the past twenty years, numerous specific pharmacologic agents targeting the endothelial dysfunction associated with PAH have emerged. Short term placebo-controlled randomized trials assessing PAH-specific monotherapy with these molecules have reported improvements in pulmonary hemodynamics and exercise capacity. A recent meta-analysis also documented a reduction in short-term mortality of about ≈40% with such therapies. Several randomized clinical trials evaluating PAH-specific combination therapy have been conducted. Our recent meta-analysis showed that combination therapy was associated with a 35% risk reduction for the occurrence of clinical worsening compared to monotherapy. Nonetheless, the investigators also showed 17% of PAH patients receiving combination therapy still experienced clinical worsening over a median exposure of 16 weeks. Moreover, long-term survival on PAH-specific also therapy remains poor in the modern era, with a yearly mortality rate of 15 % in incident idiopathic PAH. The identification of innovative therapeutic targets and validation of these complementary therapeutic interventions are thus urgently needed in PAH.
The investigators and others (K. Stenmark, University of Colorado and H. Bogaard, VU University Medical Center, Amsterdam, personal communications), have published strong evidence that BRD4 plays a key role in the pathological phenotype in PAH accounting for disease progression and showed that BRD4 inhibition can reverse PAH in several animal models. Intriguingly, coronary artery disease (CAD) and metabolic syndrome are more prevalent in PAH compared with the global population, suggesting a link between these diseases. Interestingly, BRD4 is also a trigger for calcification and remodeling processes and regulates transcription of lipoprotein and inflammatory factors, all of which are important in PAH and CAD. Apabetalone, an orally available BRD4 inhibitor, is now in a clinical development stage with a good safety profile.
The overall objective of the study is to explore the efficacy and safety of apabetalone as an add-on therapy for adult PAH patients and to inform the conduct and the design of a Phase 3 trial.
The primary objective of the study is to assess the efficacy of apabetalone as evaluated by the change in PVR over a period of 24 weeks compared to placebo in adult subjects with PAH on stable background therapy.
Secondary objectives include changes at week 24 in 6MWD, plasma NT-proBNP concentration, WHO functional class, ESC/ERS risk stratification score, health-related quality of life and additional hemodynamic data from right heart.
Exploratory objectives are to evaluate the effects of apabetalone compared to placebo in adult subjects with PAH on mortality and clinically relevant morbidity events, and on circulating levels and transcription changes in whole blood markers of metabolism, vascular calcification, inflammation, DNA damage and leucocyte expression of BMPR2.

Start Date01 Oct 2023

Sponsor / Collaborator

Université Laval

[+2]

100 Clinical Results associated with Apabetalone

100 Translational Medicine associated with Apabetalone

100 Patents (Medical) associated with Apabetalone

Literatures (Medical) associated with Apabetalone

01 Nov 2024·PHARMACOLOGICAL RESEARCH

Commentary on "Apabetalone, a BET protein inhibitor, inhibits kidney damage in diabetes by preventing pyroptosis via modulating the P300/H3K27ac/PLK1 axis".

Letter

Author: Xia, Xue ; Tong, Ying ; Li, Kaiqing ; Fu, Tong

A review.A review discussing role of the BET protein inhibitor Apabet- alone in attenuating kidney injury by targeting BRD4 protein to regulate the P300/H3K27ac/PLK1 axis and inhibiting NLRP3 inflammasome activation and cellular pyroptosis.It also discusses pharmacol. and genetic approaches to explore the effects of Apabetalone on cellular juxtaposition in a db/db mouse model and human renal tubular epithelial cells and found that Apabetalone or BRD4 siRNA could inhibit PLK1 in HK-2 cells.

01 Oct 2024·PHARMACOLOGICAL RESEARCH

Exploring the therapeutic potential of apabetalone in diabetic kidney disease: Bridging preclinical findings with clinical translation

Letter

Author: Shen, Wei ; Zhao, Guo ; Yao, Yi ; Luo, Honglian ; Wang, Wenhua

01 Oct 2024·PHARMACOLOGICAL RESEARCH

Correspondence: Reply to commentary on “Apabetalone, a BET protein inhibitor, inhibits kidney damage in diabetes by preventing pyroptosis via modulating the P300/H3K27ac/PLK1 axis”

Letter

Author: Huang, Zhaohui ; Wang, Min ; Fan, QiuLing

A polemic response to Apabetalone, a BET protein inhibitor, inhibits kidney damage in diabetes by preventing pyroptosis via modulating the P300/H3K27ac/PLK1 axis.First, we performed randomized grouping by the random number table method.One of type 2 diabetic patient had a UACR of less than 30 mg/g and an eGFR of 55 mL/min/1.73 m2, and his renal biopsy pathol. was that of type 2 DKD, with KW nodules visible, and so was a non-proteinuric diabetic kidney disease.DKD is a heterogeneous disease.Although animal models have played an important role in promoting the study of DKD, it must be pointed out that the incidence of DKD in animals and humans is not uniform.Apabetalone improves UACR levels in db/db mice, without affecting changes in body weight and hyperglycemia.PLK1 expression was found to be increased in renal biopsies of DKD patients, kidney tissue of diabetic db/db mice and in HG-treated HK-2 cells.Our results revealed that apabtalone inhibits PLK1 expression through BRD4, attenuating cell pyroptosis, inflammation, and fibrosis and thus exerts a protective role.Our current study is a pilot study and have a lot of limitations.We will continue to do the clin. trials as your kindly and valuable comments.

News (Medical) associated with Apabetalone

28 May 2024

·www.biospace.com

Resverlogix Announces Updated Annual and Special Meeting of Shareholders

Calgary, Alberta--(News - May 28, 2024) - Resverlogix Corp. (TSX: RVX) ("Resverlogix" or the "Company") announced today that its Annual and Special Meeting of Shareholders (the "Meeting") will be held on Wednesday, July 31, 2024, commencing at approximately 1:00 pm (MT), as opposed to as previously scheduled for June 27, 2024. A Notice of Meeting and Management Information Circular, containing the matters to be considered at the Meeting, will be delivered to shareholders and filed on SEDAR+ at . Following the formal business of the Meeting, a corporate update presentation will be provided. About Resverlogix Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company, and a world leader in epigenetics, with the goal of developing first-in-class therapies for the benefit of patients with chronic disease. Resverlogix is developing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. We aim to improve patients' lives by restoring biological functions – altered by serious illnesses such as cardiovascular disease – back to a healthier state. The Company's clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease, associated comorbidities, and post COVID-19 conditions. Resverlogix has partnered with EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for cardiovascular disease, post COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States. Resverlogix common shares trade on the Toronto Stock Exchange (TSX: RVX). Follow us on: Twitter: @Resverlogix_RVX LinkedIn: Forward-Looking Statements: This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts", and other similar expressions. In particular, this news release includes forward looking information related to the upcoming Annual and Special Meeting of Shareholders and the potential role of apabetalone in the treatment of patients with cardiovascular disease, post COVID-19 conditions, pulmonary arterial hypertension, associated comorbidities, and other chronic diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR+ at . The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For further information please contact: Investor Relations Email: ir@resverlogix.com Phone: 403-254-9252 Or visit our website: To view the source version of this press release, please visit

22 Feb 2024

·www.biospace.com

Resverlogix Announces Change to Its Board of Directors.

Calgary, Alberta--(News - February 21, 2024) - Resverlogix Corp. (TSX: RVX) ("Resverlogix" or the "Company") today announced that Shawn Lu has stepped down from the Board of Directors, effective today. "We would like to thank Shawn for his contributions and wish him all the best," said Donald McCaffrey, Resverlogix's President and CEO. About Resverlogix Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company, and a world leader in epigenetics, with the goal of developing first-in-class therapies for the benefit of patients with chronic disease. Resverlogix is developing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. We aim to improve patients' lives by restoring biological functions - altered by serious illnesses such as cardiovascular disease - back to a healthier state. The Company's clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease, associated comorbidities, and post COVID-19 conditions. Resverlogix has partnered with EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for cardiovascular disease, post COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States. Resverlogix common shares trade on the Toronto Stock Exchange (TSX: RVX). Follow us on: Twitter: @Resverlogix_RVX LinkedIn: For further information please contact: Investor Relations Email: ir@resverlogix.com Phone: 403-254-9252 Or visit our website: This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts", and other similar expressions. In particular, this news release includes forward looking information related to the potential role of apabetalone in the treatment of patients with cardiovascular disease, post COVID-19 conditions, pulmonary arterial hypertension, associated comorbidities, and other chronic diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at . The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To view the source version of this press release, please visit

Executive Change

11 Jan 2024

·www.biospace.com

Resverlogix Announces Publication of its 40th Scientific Journal Article on Apabetalone's Potential Therapeutic Benefits

Calgary, Alberta--(News - January 11, 2024) - Resverlogix Corp. (TSX: RVX) ("Resverlogix", "the Company") today announced publication of an article, entitled, "The BET inhibitor apabetalone decreases neuroendothelial proinflammatory activation in vitro and in a mouse model of systemic inflammation," by Dr. Sylwia Wasiak and colleagues, in Translational Neuroscience. This publication marks the 40th peer-reviewed scientific journal article published by Resverlogix researchers on apabetalone's potential therapeutic benefits. Apabetalone's Publication Record: Articles on apabetalone have been published in some of the world's most prestigious scientific journals, including: Nature, Science, Cell, the Journal of the American Medical Association, Cardiovascular Diabetology and the Clinical Journal of the American Society of Nephrologists Resverlogix researchers and our collaborators have published 40 articles on apabetalone in scientific journals, and including work by third-party researchers, there are more than 100 articles on apabetalone in the academic literature This body of work presents evidence of apabetalone's potential in the treatment of cardiovascular disease, diabetes, post-COVID-19 conditions, chronic kidney disease, and vascular cognitive impairment, as well as rare diseases such as pulmonary arterial hypertension, facioscapulohumeral muscular dystrophy, and Fabry's disease The publications also cover a wide spectrum of topics from investigations of apabetalone's mechanism of action at a molecular level, to reports on large-scale clinical trials with thousands of participants "We are very proud of our publication record on apabetalone," said Dr. Ewelina Kulikowski, Chief Scientific Officer at Resverlogix. "Thanks to the dedicated work of our researchers, we have learned an incredible amount about this drug; how it works, why it's safe, and how it can potentially benefit people suffering from chronic disease." "The depth and breadth of our knowledge of apabetalone is on full display in the forty scientific articles that we have published to date," said Donald McCaffrey, President and CEO at Resverlogix. "We firmly believe that apabetalone will help chronic disease patients, we have published an extraordinary amount of evidence that supports our belief, and we are looking forward to conclusively demonstrating it in our upcoming, Phase 3, cardiovascular disease trial, BETonMACE2." Highlights from our Latest Publication: Inflammation in the small blood vessels of the brain is linked to cognitive impairment and decline Using cultured human brain endothelial cells and monocytes, the authors studied apabetalone's effects on inflammation in these small vessels They found that apabetalone treatment reduced the production of pro-inflammatory molecules and cell-cell interactions Their findings were confirmed in a mouse model of brain inflammation, where apabetalone decreased the expression of pro-inflammatory genes By lessening inflammation in the small blood vessels of the brain, apabetalone may help prevent or treat vascular cognitive impairment Our latest article is published online HERE. About Apabetalone Apabetalone (RVX-208), is a first-in-class, small molecule, therapeutic candidate with an epigenetic mechanism of action. It is a BD2 (bromodomain) selective BET (bromodomain and extra-terminal) inhibitor that works in preventing and treating disease by regulating the expression of disease-causing genes. Due to the extensive role for BET proteins in the human body, apabetalone can simultaneously target multiple disease-related biological processes representing a new way to treat chronic disease. Apabetalone is the only drug of its class that is well tolerated for chronic administration, with an established safety record across multiple human clinical trials, totaling over 4200 patient-years of safety data. Cardiology: Apabetalone is the first therapy of its kind to receive Breakthrough Therapy Designation from the US Food & Drug Administration for a major cardiovascular indication. This followed the ground-breaking findings from its Phase 3 study, BETonMACE, which showed apabetalone may prevent major adverse cardiac events among high-risk cardiovascular disease patients who also have type 2 diabetes mellitus. About Resverlogix Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company and the world leader in epigenetics, with the goal of developing first-in-class therapies for the benefit of patients with chronic disease. Resverlogix is developing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. We aim to improve patients' lives by restoring biological functions - altered by serious illnesses such as cardiovascular disease - back to a healthier state. The Company's clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease, associated comorbidities, and post COVID-19 conditions. Resverlogix has partnered with EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for cardiovascular disease, post COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States. Resverlogix common shares trade on the Toronto Stock Exchange (TSX: RVX). Follow us: Twitter: @Resverlogix_RVX. LinkedIn: . Forward-Looking Statements: This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts", and other similar expressions. In particular, this news release includes forward-looking information related to the potential role of apabetalone in the treatment of patients with cardiovascular disease, diabetes, chronic kidney disease, vascular cognitive impairment, COVID-19, post COVID-19 conditions, pulmonary arterial hypertension, facioscapulohumeral muscular dystrophy, Fabry's disease, associated comorbidities, and other chronic diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at . The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For further information please contact: Investor Relations Email: ir@resverlogix.com Phone: 403-254-9252 To view the source version of this press release, please visit

Phase 3Breakthrough Therapy

100 Deals associated with Apabetalone

External Link

KEGG	Wiki	ATC	Drug Bank
D11131	Apabetalone	-	DB12000

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post Acute COVID 19 Syndrome	Phase 3	JO	Resverlogix Corp.	30 Nov 2024
Post Acute COVID 19 Syndrome	Phase 3	SA	Resverlogix Corp.	30 Nov 2024
Post Acute COVID 19 Syndrome	Phase 3	AE	Resverlogix Corp.	30 Nov 2024
COVID-19	Phase 3	CA	Resverlogix Corp.	14 Jan 2022
Coronary Artery Disease	Phase 3	AR	Resverlogix Corp.	01 Nov 2015
Coronary Artery Disease	Phase 3	AU	Resverlogix Corp.	01 Nov 2015
Coronary Artery Disease	Phase 3	BE	Resverlogix Corp.	01 Nov 2015
Coronary Artery Disease	Phase 3	BG	Resverlogix Corp.	01 Nov 2015
Coronary Artery Disease	Phase 3	HR	Resverlogix Corp.	01 Nov 2015
Coronary Artery Disease	Phase 3	DE	Resverlogix Corp.	01 Nov 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02586155 (BETonMACE, ERA2023)	Phase 3	Chronic Kidney Diseases	-	Apabetalone 100 mg	hmfeuhcdxl(dbxlxcshdu): HR = 0.5 (95% CI, 0.26 - 0.96), P-Value = 0.04	Positive	14 Jun 2023
				Placebo
BETonMACE2 \| BETonMACE (ASN2021)	Phase 3	-	-	Apabetalone 1-25 µ M	guiarspnws(oftqcmykmj) = xbbigfmira aiyyjkkyjl (dzvzbvwofp ) View more	Positive	27 Oct 2021
NCT03655704 (APPRoAcH-p, GlobeNewswire) Manual	Phase 1	Pulmonary Arterial Hypertension	7	Apabetalone	pcqyfcynkf(ckrvahozsf) = improved hyqkousoip (jtbowdvasa )	Positive	08 Sep 2021
NCT02586155 (BETonMACE, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Coronary Artery Disease	2,425	rosuvastatin+atorvastatin+Apabetalone (High-Intensity Statin Therapy+RVX000222)	tavgoerzgf(ejaalvcdzb) = jiwazdmlat peeokdghgx (ehnyehhzbt, ptgtkojnwl - tismwvbqwl) View more	-	20 Aug 2021
				Placebo+rosuvastatin+atorvastatin (High-Intensity Statin Therapy+Placebo)	tavgoerzgf(ejaalvcdzb) = xwpgyjyzcv peeokdghgx (ehnyehhzbt, bpemyqsdqi - tlfdneghid) View more
BETonMACE \| BETonMACE2 (ERA2021)	Phase 3	Chronic Kidney Diseases	-	APABETALONE (TGF-β1)	beghgqtqub(sglbierllm) = tiuopsoren vfzocirubc (yosgwljhbq ) View more	Positive	29 May 2021
				APABETALONE (LPS)	(nykpynkuii) = vzomrxqgds dpnzgrkunq (nhxeltoexd )
AAI2021	Not Applicable	Fabry Disease	-	Apabetalone	uwtiwimfol(jygjjgchwh) = hfdognrozb itudoluyhh (nobqmqkewf )	-	01 May 2021
BETonMACE (ASN2020)	Phase 3	-	2,425	Apabetalone	xzymrecqds(ikoygwhnel) = qpwcwrpkio eurxkytmcz (rzinsallax, 1.67 - 3.44) View more	Positive	19 Oct 2020
				Placebo	xzymrecqds(ikoygwhnel) = txeydxxhge eurxkytmcz (rzinsallax, 1.67 - 3.44) View more
BETonMACE (ERA2020)	Phase 3	Diabetes Mellitus, Type 2 \| Acute Coronary Syndrome \| Chronic Kidney Diseases	2,425	Apabetalone (ABP)	kzvsoxjwfm(nmwhrpsfma) = hgmlpqgkcj baqefipdom (wzncrddirj )	Positive	06 Jun 2020
				Placebo (PBO)	kzvsoxjwfm(nmwhrpsfma) = tjvcwtbvtr baqefipdom (wzncrddirj )
NCT02586155 (BETonMACE, Pubmed \| J Coll Physicians Surg Pak \| JAMA) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Acute Coronary Syndrome	2,425	Apabetalone	bvexfdhkse(joxhyllclq) = vujvctvtoe pygsubbbmi (onyaxdegkm ) View more	Negative	28 Apr 2020
				Placebo	bvexfdhkse(joxhyllclq) = uvsaoqmsde pygsubbbmi (onyaxdegkm ) View more
NCT02586155 (BETonMACE, Pubmed \| Am Heart J)	Phase 3	Acute Coronary Syndrome \| Diabetes Mellitus	2,425	Apabetalone 100 mg	zxhjihuxaa(ubbkevpdcy) = gjujmfcfts atdmoepxuu (auzbcfsqbu )	-	01 Nov 2019

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