Corvidia Therapeutics Initiates Phase 2b Dose-Finding Study for Ziltivekimab

• Investigational therapy targeting residual inflammatory
  cardiovascular risk in patients living with chronic kidney disease
• Phase 2b study called RESCUE based in US, enrolling more than 200
  patients
• Approximately two million chronic kidney disease patients in the US
  also have inflammation, leading to elevated cardiovascular risk

WALTHAM, Mass.–(BUSINESS WIRE)–#CorvidiaTherapeutics—Corvidia
Therapeutics Inc., a clinical stage biotechnology company, announced
today the initiation of patient screening for a Phase 2b dose-finding
study of ziltivekimab. Previously known as COR-001, ziltivekimab is a
proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6
mAb), targeting residual inflammatory cardiovascular risk in patients
living with advanced
chronic kidney disease (CKD).

In two previous early phase clinical trials in chronic kidney disease
patients with evidence
of inflammation, ziltivekimab has demonstrated that it reduced C-reactive
protein (CRP), a marker of inflammation. The trial called RESCUE (Reduction
in Inflammation in Patients with Advanced Chronic Renal Utilizing
Antibody-Medicated IL-6 Inhibition) is a randomized, double-blind,
placebo-controlled dose-finding study of ziltivekimab. The trial
explores three doses of ziltivekimab administered monthly.

“Dose-finding is a critical step that will teach us a great deal about
how targeted anti-cytokine therapy can impact the IL-6-to-CRP axis so
crucial for atherothrombosis,” said Paul
Ridker, MD, director of the Center for Cardiovascular Disease
Prevention at Brigham
and Women’s Hospital, an expert in inflammation biology and a member
of the Scientific
Advisory Board of Corvidia Therapeutics. “This dose-finding data
will also inform the design of a hard outcomes trial to test the
hypothesis that IL-6-lowering will reduce cardiovascular event rates in
patients with chronic kidney disease, which is based upon an observation
in an 1800 patient CKD subset of the CANTOS trial.” ⁱ Ridker
is providing academic oversight for the RESCUE study.

A large portion of patients with chronic kidney disease continue to be
at risk for adverse cardiovascular outcomes despite being on drugs that
control LDL
cholesterol and high
blood pressure.ⁱⁱ At least two million of these patients
demonstrate high levels of the inflammatory marker CRP, an independent
indicator of cardiovascular risk ⁱⁱⁱ. These patients also
have high cardiovascular morbidity and mortality^iv;
ziltivekimab is being evaluated for its ability to address this
inflammatory condition.

“We are pleased to initiate the RESCUE trial, marking the next phase of
development of ziltivekimab,” said Michael
Davidson, MD, chief scientific officer of Corvidia Therapeutics.
“Treating inflammation has the potential to be the next major advance in
cardiovascular risk reduction and we are excited to lead the way. We
also look forward to working with the FDA on the development of
ziltivekimab for a patient population with a high unmet need.”

The RESCUE study will enroll 240 patients living with CKD stages three
to five with evidence of inflammation, with the primary endpoint being
inflammation (CRP) reduction at six months. Study enrollment will occur
in 50 centers across the United States. Corvidia Therapeutics is
expecting to report data results from the RESCUE study in the second
half of 2020. For more information on the trial, visit www.clinicaltrials.gov

About Corvidia Therapeutics Inc.

Corvidia Therapeutics Inc. is a clinical stage biotechnology company
based in Waltham, Massachusetts developing ground-breaking therapies for
cardio-renal disease. Corvidia’s pipeline programs are presently focused
on the next generation of therapies. Among our portfolio of novel
therapeutic candidates, we have an experimental therapy in Phase 2b
development addressing inflammation in CKD. Corvidia’s other preclinical
programs are in various stages of development. For more information,
please visit www.corvidiatx.com

__________________________
ⁱ Ridker PM, MacFadyen JG,
Glynn RJ, Koenig W, Libby P, Everett BM, Lefkowitz M, Thuren T, Cornel
JH. 2018. Inhibition of Interleukin-1β by Canakinumab and Cardiovascular
Outcomes in Patients with Chronic Kidney Disease. J Am Coll Cardiol.
71(21): 2405-2414.

ⁱⁱ Fellström B, Holdaas H, Jardine AG, Holme I, Nyberg G,
Fauchald P, Grönhagen-Riska C, Madsen S, Neumayer HH, Cole E, et. al.
2004. Effect of fluvastatin on renal end points in the Assessment of
Lescol in Renal Transplant (ALERT) trial. Kidney Int. 66(4):1549–1555.

ⁱⁱⁱ Arnett DK, Blumenthal RS, Albert MA, Michos ED, Buroker
AB, Miedema MD, Goldberger ZD, Munõz D, Hahn EJ, Smith SC, et. al. 2019.
ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A
Report of the American College of Cardiology/American Heart Association
Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. DOI: https://doi.org/10.1016/j.jacc.2019.03.010

^iv Ridker PM. 2018. Clinician’s Guide to Reducing
Inflammation to Reduce Atherothrombotic Risk: JACC Review Topic of the
Week. J Am Coll Cardiol. 72 (25). DOI: 10.1016/j.jacc.2018.06.082

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Contacts

Press Inquiries:
McDougall Communications on behalf of
Corvidia Therapeutics Inc.
Contact: Elizabeth Harness, [email protected],
Tel: +1 (585) 435 -7379