Mr. Donald McCaffrey reports
RESVERLOGIX PRESENTS NEW COMPLEMENT DATA AND ESTABLISHES RENAL CLINICAL
ADVISORY BOARD AT THE 53RD ANNUAL EUROPEAN RENAL ASSOCIATION - EUROPEAN
DIALYSIS & TRANSPLANT ASSOCIATION CONGRESS (ERA-EDTA)
Resverlogix Corp. has presented new data at the European Renal Association -- European
Dialysis & Transplant Association (ERA-EDTA)
Congress in Vienna, Austria, in a poster titled, "Apabetalone (RVX-208), a
Selective Bromodomain and Extra-Terminal (BET) Protein Inhibitor, Decreases
Abundance and Activity of Complement Proteins in Vitro, in Mice and in
Clinical Studies." The company is also pleased to announce the formation of an
international renal clinical advisory board (RCAB) for the future development
of apabetalone into expanded renal indications.
New complement data announced at ERA-EDTA Congress -- Vienna, Austria
The immune system is the body's way of protecting itself from attacking
foreign invaders, such as bacteria, viruses, illness and disease. The
complement cascade is part of this protective response; however, pathological
activation of the cascade underlies multiple human diseases, including several
inflammatory, autoimmune, neurodegenerative and infectious diseases.
New data demonstrated that when exposed to apabetalone, primary human liver
cells significantly down regulate the expression of complement components. This
was observed at both the gene expression and protein level, and occurred at
steady state (when unstimulated) and when the cells were stimulated with
factors known to cause inflammation and immune response activation. This is
particularly important in conditions where these factors are overactive or
present in excessive quantities. Moreover, in an apabetalone-treated mouse
model, where mouse liver cells are replaced with human liver cells, reductions
in expression of components C4, C9 and MBL2 mRNA of the complement cascade,
decreased by 36 per cent, 46 per cent and 61 per cent respectively. To
establish if the observed decrease in protein abundance affected activity,
hemolytic assays were performed on 11 plasma samples from patients with
cardiovascular disease (CVD) at baseline and after 26 weeks of apabetalone
treatment. Results showed a significant decrease in activity of approximately
26 per cent (p less than 0.01) in both assays. No increase in infections was reported in
phase 2 trials.
This effect of apabetalone treatment on complement component expression and
cascade activity may have an impact on the pathologic activation of this
cascade in chronic kidney disease (CKD). The potential of apabetalone for the
treatment of high-risk diabetes and CKD patients is currently being explored
in the company's phase 3 BETonMACE clinical study.
Dr. Kamyar Kalantar-Zadeh, chairman of the RCAB, stated: "BET inhibition with
apabetalone represents a novel and compelling approach for diabetes and CKD
treatment. This data, in combination with previously published findings on
novel biomarkers and pathways affected by select BET inhibition with known
roles in CVD and CKD, such as coagulation, vascular calcification and
inflammation, provide a potentially unique and multifactorial approach to
disease reduction. The RCAB intend to examine expanded opportunities in renal
disease where patients have a significant risk for major adverse cardiac
events (MACE) such as death, stroke, heart failure and myocardial infarction.
"This new data is an important step for the company as we continue to develop
our proprietary BET data for high-risk CVD patients, and apply these learnings
into additional indications in kidney and renal orphan diseases," said Donald McCaffrey, president and chief executive officer. "The data showing that select BET
inhibition is modulating key pathways and proteins known to play a role in
renal disease is directly responsible for attracting world-class leaders in
the field of renal disease research to help expand and direct our efforts."
Members of the Resverlogix international renal clinical advisory board:
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Dr. Kalantar-Zadeh (chair): Dr. Kalantar-Zadeh is professor and chief,
division of nephrology and hypertension, at University of California, Irvine.
Dr. Kalantar-Zadeh is the founder and director of the Harold Simmons Center
for Kidney Disease Research and Epidemiology. Among his numerous appointments
in the renal field, Dr. Kalantar-Zadeh is associate editor of several
peer-reviewed journals, including Nephrology Dialysis Transplantation (NDT),
American Journal of Kidney Diseases (AJKD), Cardiorenal Medicine (CRM),
Seminars in Dialysis, Sarcopenia and Muscle (JCSM), and a member of the
editorial board of Journal of Kidney International (KI), Journal of American
Society Nephrology (JASN), Nature Reviews Nephrology and American Journal of
Nephrology (AJN). Dr. Kalantar-Zadeh has authored three textbooks and over 500
peer-reviewed publications.
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Dr. Carmine Zoccali: Dr. Zoccali is a specialist in renal diseases (Pisa
University) and hypertension. Dr. Zoccali's appointments include director,
division of nephrology, hypertension and renal transplantation, Ospedali
Riuniti, Reggio Cal, Italy; chief, CNR-IBIM Clinical Epidemiology and
Pathophysiology of Renal Diseases and Hypertension; and professor, postgraduate
schools of nephrology, Palermo, Catania and Messina universities. Dr.
Zoccali's current editorial positions include editor in chief, Nephrology
Dialysis and Transplantation; academic editor, (Nephrology) PlosOne; and
editorial board member, Journal of the American Society of Nephrology (JASN); editorial board member, Clinical Journal of the American Society of Nephrology
(cJASN); and editorial board member, Kidney International (KI). Dr. Zoccali has
over 402 papers in international peer-reviewed, Pubmed-indexed journals.
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Dr. Marcello Tonelli: Dr. Tonelli is associate vice-president (research) at
the University of Calgary. Dr. Tonelli was the recipient of the 2013 United
States National Kidney Foundation Medal for Distinguished Service and the
Kidney Foundation of Canada's 2013 Medal for Research Excellence for changing
nephrology practice in Canada and beyond. Along with the two other team
co-leads, he received a Top Canadian Achievements in Health Research Award
from the CIHR-CMAJ in 2013 for his work with the interdisciplinary chronic
disease collaboration. He was elected as a fellow of the Canadian Academy of
Health Sciences in 2012 and a member of the American Society for Clinical
Investigation in 2014. He was named a highly cited researcher in 2015 by
Thomson-Reuters, corresponding to a rank in the top 1 per cent by citations of all
researchers worldwide for field and publication year.
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Dr. Vincent Brandenburg: Dr. Brandenburg is nephrologist, associate professor
and senior consultant at the department of cardiology, intensive care medicine
and vascular medicine, university hospital of the RWTH Aachen, Germany. Dr.
Brandenburg has been leader of the German calciphylaxis registry
since 2007. He is a board member of the European Renal Association -- European Dialysis and Transplantation
Association (ERA-EDTA) scientific working group, chronic kidney disease -- mineral and bone disorder
(CKD-MBD). Dr. Brandenburg has authored or co-authored over 140 articles in
peer-reviewed journals. These articles have had the primary focus upon chronic
kidney disease -- mineral and bone disorder, cardiorenal syndrome, and
calciphylaxis. He is a member of the German and European societies of
nephrology and the societies of cardiology.
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Dr. Srinivasan Beddhu: Dr. Srinivasa Beddhu, MD, is a tenured professor of medicine at
the University of Utah School of Medicine. He is board certified in internal
medicine and nephrology. Dr. Beddhu received his medical degree from Stanley
Medical College, Chennai, India. His clinical and research interests include
hypertension, chronic kidney disease progression and complications, and
end-stage renal disease. Dr. Beddhu's research is funded primarily by NIH
grants. He has served in several national committees, including NIH panels,
American Society of Nephrology Research Committee and NKF clinical practice
guidelines committee. Dr. Beddhu has published about 100 articles, including
peer-reviewed publications, editorials and book chapters.
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Dr. Mathias Haarhaus: Dr. Haarhaus is a consultant nephrologist at the
department of nephrology, Karolinska University Hospital, Stockholm, Sweden,
where he is head of the bone and mineral program. His research at the division
of renal medicine, Karolinska Institutet, mainly focuses on the link between
skeletal disorders and cardiovascular complications in chronic kidney disease,
with a special focus on alkaline phosphatase. He is an active member of the CKD-MBD working group
of the ERA-EDTA and a member of the guidelines committee of the Swedish
Society of Nephrology.
We seek Safe Harbor.
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