Hoffe, daß es jetzt dann so richtig losgeht! :-)
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Resverlogix Announces Topline Results in BETonMACE Phase 3 Epigenetics Trial
BETonMACE did not meet the primary endpoint
- Apabetalone development to continue to be advanced by the Company based on BETonMACE results
- Primary results to be presented during a late-breaking science session at AHA 2019
- Apabetalone demonstrated tolerability and safety
- Resverlogix to host investor webcast and conference call on Monday, September 30, 8:30 am ET
CALGARY, Alberta, Sept. 30, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) announces that BETonMACE did not meet the primary endpoint – reduction in major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction and stroke – added to standard of care in high-risk patients with type 2 diabetes, recent acute coronary syndrome, and low HDL cholesterol. Apabetalone demonstrated tolerability and safety. Full study results will be presented during a late-breaking science session at AHA 2019 (the details of which are below).
“We look forward to presenting the full and detailed results of this novel therapeutic approach in a population, that despite optimal care, remains at high risk for additional cardiovascular events,” said Kausik K. Ray, M.D., BETonMACE study chair and Professor of Public Health and Consultant Cardiologist at Imperial College London.
“We are proud as a Company to be developing apabetalone and explore its potential to reduce cardiovascular events in patients at high risk,” says Donald McCaffrey, President and CEO of Resverlogix. “I believe the results from BETonMACE will be a key stepping stone to advance this novel therapy to address unmet medical need and we will continue to advance our programs moving forward.”
“In addition to the primary results, we look forward to reporting our secondary and exploratory endpoints in the near future,” commented Dr. Michael Sweeney, Senior Vice President, Clinical Development of the Company.
The primary results of the BETonMACE trial will be presented in the near future during the American Heart Association’s (“AHA”) Scientific Sessions 2019 held in Philadelphia, Pennsylvania, and submitted for peer review. The presentation is currently scheduled for approximately 11:42 am ET on November 16, 2019
https://web.tmxmoney.com/...newsid=6809674197522504&qm_symbol=RVX
Ich glaub’s nicht :-))) mal sehen was jetzt passiert
BTD nach einer gefloppten Phase 3 Studie
https://twitter.com/adamfeuerstein/status/1224315902822404096
Optionen
| Boardmail an "Vassago" |
Wertpapier: Resverlogix Corp |
Die BTD zielt doch nicht auf die verfehlten Primary Endpoints der Phase 3 ab.
Resverlogix Clinical Candidate Apabetalone Featured as a Potential COVID-19 Treatment in Recent Publication
CALGARY, Alberta, March 24, 2020 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) is pleased to announce a March 23, 2020 bioRxiv publication that has shown apabetalone to inhibit specialized proteins – called bromodomain and extraterminal domain (BET) proteins – from interacting with a SARS-CoV-2 viral protein, with potential for limiting viral reproduction in human cells.
The article titled: “A SARS-CoV-2-Human Protein-Protein Interaction Map Reveals Drug Targets and Potential Drug-Repurposing” by Gordon et al, identified BRD2/4 as a binding partner of viral protein E. Apabetalone was shown to disrupt this interaction. A paragraph in the publication states the following about Bromodomain proteins:
SARS-CoV-2 envelope interacts with bromodomain proteins
Surprisingly, we find that the transmembrane protein E binds to the bromodomain-containing proteins BRD2 and BRD4, potentially disrupting BRD-histone binding by mimicking histone structure. BRD2 is a member of the bromodomain and extra-terminal (BET) domain family whose members bind acetylated histones to regulate gene transcription. The N-terminus of histone 2A shares local sequence similarity over an alpha-helix of approximately 15 residues, some of which are in a transmembrane segment, of Protein E (Gordon et al., 2020, p.7).
“This novel research is certainly very encouraging and warrants additional testing of apabetalone, our investigational phase 3 clinical candidate with safety data in more than 4,000 subjects,” said Donald McCaffrey, President and CEO of Resverlogix. “Harnessing epigenetic modulation may be a potent tool in slowing down COVID-19 virus spread and disease severity, and as we announced yesterday, we would like to collaborate quickly with anyone who is testing drugs for COVID-19 in preclinical and clinical studies.”
Interested COVID-19 collaborators can contact:
Donald McCaffrey, President & CEO
don@resverlogix.com
1-587-390-7888
https://web.tmxmoney.com/...newsid=6826620583441370&qm_symbol=RVX
Das ist aber nur ein positiver Nebeneffekt von Apabetalone...
Morgen webcast mit Operationalisierung Update.
Aktuell in Kanada +36%...
CALGARY, Alberta, June 22, 2020 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix") (TSX:RVX) is pleased to announce that the U.S. Food & Drug Administration (FDA) has accepted its BETonMACE2 clinical plan as a registration enabling study with positive implications for Resverlogix and its ongoing partnership discussions. Key written development points from a recent meeting with the FDA include the following:
Filing of a New Drug Application (NDA) with the FDA is possible following unequivocal efficacy at an interim analysis of BETonMACE2
All or most BETonMACE2 patients to receive top standard of care, including maximized use of SGLT2 inhibitors (SGLT2i)
BETonMACE2 to increase enrichment of chronic kidney disease (CKD) patients, potentially including those with lower baseline renal function
Based on BETonMACE results, the FDA encouraged the evaluation of a non-alcoholic fatty liver disease (NAFLD) subgroup as well as related exploratory endpoints
The purpose of the Comprehensive Multidisciplinary Initial Breakthrough Therapy Designation (BTD) meeting held between the FDA and Resverlogix on June 2, 2020 was to discuss the ongoing development program for apabetalone following receipt of the company’s Breakthrough Therapy Designation announced on February 3, 2020.
“I am extremely pleased with the very constructive BTD discussions with the FDA to-date and look forward to our ongoing work and future progress,” stated Donald McCaffrey, President & CEO of Resverlogix. “Several customary topics were discussed during our recent meeting with regards to the ongoing development requirements for apabetalone and the eventual filing of a NDA. Significantly, the Company’s overall study design for BETonMACE2 – the planned clinical study subsequent to BETonMACE – was accepted by the FDA and we expect this will greatly enhance our current and ongoing partnership discussions.”
The FDA recommended that all or most BETonMACE2 participants be on a background of top standard of care, including SGLT2i, as clinically indicated. BETonMACE revealed significant, potential synergy with apabetalone and new diabetes drugs including SGLT2i. Among those receiving SGLT2i, a hazard reduction of 60% in the primary endpoint was seen in patients receiving apabetalone and top standard of care, compared to placebo and top standard of care alone.
In addition, the Company will explore and consider additional criteria for future FDA discussion including lower degrees of renal function than that of BETonMACE participants. BETonMACE patients on apabetalone with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 at baseline saw a 50% hazard reduction in the primary endpoint for this chronic kidney disease subgroup. This was compared to patients receiving placebo and top standard of care alone.
Lastly, additional data analysis from BETonMACE suggests that patients with NAFLD may experience a reduction in major adverse cardiac events and hospitalization for heart failure (MACE+HHF) when on apabetalone and top standard of care. The FDA has encouraged the Company to explore subgroups in BETonMACE2 that could differentially derive benefit from MACE+HHF reduction.
Breakthrough Therapy Designation
According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
Expedited programs, including Breakthrough Therapy Designation, help ensure that therapies for serious conditions are available as soon as it can be concluded that the therapies’ benefits justify their risks, taking into account the seriousness of the condition and the availability of alternative treatment.
About BETonMACE
In the fall of 2019, Resverlogix reported results from its Phase 3 trial BETonMACE. BETonMACE was a clinical trial that tested apabetalone treatment to impact primary MACE on 2,425 CVD patients with diabetes and a recent acute coronary syndrome event. The trial in its primary endpoint of primary MACE in the entire population had a hazard reduction of 18% versus placebo. In the pre-specified CKD sub population, apabetalone significantly reduced both primary MACE and hospitalizations due to congestive heart failure in comparison to placebo with top standard of care. Apabetalone’s consistent safety profile was further validated by an analysis of adverse events in BETonMACE, and nine positive reports by the trial’s independent Data and Safety Monitoring Board.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.
BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
Follow us on:
Twitter: @Resverlogix_RVX
LinkedIn: https://www.linkedin.com/company/resverlogix-corp-/
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
Or visit our website: www.resverlogix.com
https://web.tmxmoney.com/...newsid=6197601198369196&qm_symbol=RVX
Resverlogix Announces Publication in High-impact, Peer-reviewed Journal, Clinical Epigenetics
Publication Explores the Beneficial Effects of Apabetalone on the Immune Cells of Diabetic Patients
Event Reminder: Multiple Presentations on Apabetalone to be made during the American Heart Association Scientific Sessions – November 13-17
CALGARY, Alberta, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the recent publication of an article titled: “BET protein inhibitor apabetalone (RVX-208) suppresses pro-inflammatory hyper-activation of monocytes from patients with cardiovascular disease and type 2 diabetes”, in the high-impact, peer-reviewed Clinical Epigenetics.
The publication can be viewed using the following LINK. As previously announced, additional information related to this study, and others on apabetalone, will be presented in an oral presentation at the 2020 American Heart Association (AHA) Scientific Sessions (see details below).
“Building on our previous work, this study shows apabetalone treatment works directly on immune cells that contribute to cardiovascular disease and has great potential to reduce cardiovascular risk in diabetes and chronic kidney disease patients,” said Dr. Ewelina Kulikowski, Senior Vice President, Research & Development at Resverlogix, and a corresponding author of the paper. “In addition, during the coming AHA meeting, we look forward to presenting additional BETonMACE findings including how apabetalone may prove beneficial in preventing SARS-CoV-2 viral entry in human cell lines.”
Publication Highlights include:
•Immune cells taken directly from diabetes and cardiovascular disease patients have an activated state of inflammation compared to the cells of matched control patients
•When immune cells are activated by inflammation, it can trigger a cascade of events leading to vascular damage and disease
•Apabetalone treatment dampens the response of immune cells to inflammation, preventing them from activating unnecessarily, and reversing damaging disease processes
•These findings may help explain apabetalone’s beneficial effect on cardiovascular outcomes, as observed in BETonMACE
Publication Background and Conclusions:
Activation of immune cells is an important process in the development of atherosclerosis and contributes to cardiovascular risk. The findings published in this article highlight the central role of BET proteins in driving the expression of disease risk factors in patients with diabetes and cardiovascular disease. Apabetalone treatment, acting at the epigenetic level, can reduce the activation of disease-promoting cells, helping us better understand how BET inhibitors reduce cardiovascular and chronic kidney disease risk in type 2 diabetes patients.
Event Reminder – AHA Scientific Sessions, November 13-17, 2020
Through participation at leading industry events, including the AHA Scientific Sessions, the Company continues to highlight apabetalone and its ability to regulate multiple biological pathways that underlie chronic disease, as well as presenting new research related to COVID-19. Further details of the presentations are outlined below, and the posters may be found HERE, when available.
•Oral Presentation: BET Protein Inhibitor Apabetalone Suppresses Inflammatory Hyperactivation of Monocytes from Patients with Cardiovascular Disease and Type 2 Diabetes ◦Presentation will discuss the important role of macrophage hyperactivation in driving CVD in diabetic patients and demonstrate apabetalone’s reduction of maladaptive gene expression in these cells
•Poster Presentation: Apabetalone (RVX-208) Reduces ACE2 Expression in Human Cell Culture Systems, Which Could Attenuate SARS-CoV-2 Viral Entry ◦New data will be presented showing apabetalone treatment reduces expression of the angiotensin converting enzyme 2 (ACE2) receptor that is essential for SARS-CoV-2 viral entry, in human cell lines
•Poster Presentation: Reduction in the Risk of Major Adverse Cardiovascular Events with Apabetalone, a BET Protein Inhibitor, in Patients with Recent Acute Coronary Syndrome and Type 2 Diabetes According to Insulin Treatment: Analysis of the BETonMACE Trial ◦A new post-hoc analysis of BETonMACE will be presented examining the risk of major adverse cardiovascular events (MACE) events to enrolled patients according to their concomitant insulin treatment
About Resverlogix
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.
BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
https://ceo.ca/@nasdaq/...lication-in-high-impact-peer-reviewed-250f0
https://ceo.ca/@nasdaq/...a-issues-resverlogix-authorization-to-begin