Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage
biotechnology company developing therapies for patients with kidney
disease (the “Company or “Unicycive”), today announced that the
peer-reviewed international journal the American Journal of
Nephrology has published positive results on the phosphate binding
capacity for oxylanthanum carbonate (OLC). The Company also
announced the adoption of the non-proprietary name, oxylanthanum
carbonate (OLC) by the United States Adopted
Name (USAN) organization, replacing lanthanum
dioxycarbonate (LDC) which has been used in previous publications
and company presentations. OLC is Unicycive’s investigational
phosphate binding agent utilizing proprietary nanoparticle
technology being developed as a lower pill burden option for the
treatment of hyperphosphatemia in chronic kidney disease (CKD)
patients on dialysis.
The publication, entitled, “High
Phosphate-Binding Capacity of Oxylanthanum Carbonate with a Low
Medication Volume: Comparison with Commercially Available Phosphate
Binders,” showed that OLC had the lowest daily phosphate binder
dose volume and the lowest volume required to bind 1 g of phosphate
compared to five other commercially available phosphate
binders.
“The published data supports our other studies
demonstrating that oxylanthanum carbonate has the potential to
improve medication adherence and the quality of life for patients
suffering from CKD,” said Shalabh Gupta, MD, CEO of Unicycive. “A
key focus for management of CKD is phosphate control, but currently
available binders have suboptimal phosphate-binding capacity, and
their characteristics often result in low adherence and suboptimal
phosphate regulation. OLC has the potential to reduce the pill
burden compared to commercially available products—a key point of
differentiation in the phosphate binder market.”
For patients with chronic kidney disease (CKD)
and end-stage kidney disease (ESKD), regulation of phosphate levels
between 3.0 and 4.5 mg/dl is crucial to preserve the proper
function of many biological processes, including energy metabolism,
skeletal development, and bone integrity. The development of
hyperphosphatemia, a condition where serum phosphorus concentration
rises above 4.5 mg/dL, is associated with significant
pathophysiology and increased mortality risk. Almost 75% of
patients on dialysis in the United States have serum phosphorus
concentrations greater than 4.5 mg/dL [7]; therefore, a key focus
for CKD management is phosphate control.
Stuart Sprague, DO, FASN, Chief Emeritus of the
Division of Nephrology and Hypertension at NorthShore University
HealthSystem and Clinical Professor of Medicine at the University
of Chicago Pritzker School of Medicine, and the lead author of the
study commented, “The effective management of hyperphosphatemia in
chronic kidney disease patients remains an elusive challenge
despite the commercial availability of numerous phosphate binder
options. Patients often find it difficult to adhere to their
phosphate binder prescription due to issues of high pill burden,
poor palatability, and side-effects. If approved, oxylanthanum
carbonate may offer patients a welcome, low pill burden
alternative.”
The objective of the study was to assess the
volume of OLC required to bind 1 g phosphate and to compare it with
other currently available phosphate binders, to determine which
binder allows for the highest normalized potency with the lowest
daily medication volume. The results of the study showed that the
daily phosphate binder dose volume was lowest with oxylanthanum
carbonate (OLC) (2.3 cm3) and highest with sevelamer carbonate (9.7
cm3).
Phosphate binder volumes by tablet
|
Tablet volume, cm3 |
Daily medication volume, cm3 |
Volume to bind 1g phosphate,
cm3 |
Ferric citrate (1,000 mg) |
0.92 |
7.4–8.3 |
46.5 |
Calcium acetate (667 mg) |
0.75 |
7.7 |
25.0 |
Lanthanum carbonate(500 mg lanthanum) |
1.33 |
4.0–8.0 |
19.8 |
Lanthanum carbonate (1,000 mg lanthanum) |
2.67 |
Oxylanthanum carbonate (500 mg
lanthanum) |
0.35 |
2.3 |
5.6 |
Oxylanthanum carbonate (1,000 mg
lanthanum) |
0.75 |
Sevelamer carbonate(800 mg) |
1.08 |
9.7 |
73.4 |
Sucroferric oxyhydroxide (2,500 mg) |
1.83 |
5.5–7.3 |
NR |
The full publication can be accessed here.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition
that occurs in nearly all patients with End Stage Renal Disease
(ESRD). If left untreated, hyperphosphatemia leads to secondary
hyperparathyroidism (SHPT), which then results in renal
osteodystrophy (a condition similar to osteoporosis and associated
with significant bone disease, fractures and bone pain);
cardiovascular disease with associated hardening of arteries and
atherosclerosis (due to deposition of excess calcium-phosphorus
complexes in soft tissue). Importantly, hyperphosphatemia is
independently associated with increased mortality for patients with
chronic kidney disease on dialysis. Based on available clinical
data to date, over 80% of patients show signs of cardiovascular
calcification by the time they become dependent on dialysis.
Dialysis patients are already at an increased
risk for cardiovascular disease (because of underlying diseases
such as diabetes and hypertension), and hyperphosphatemia further
exacerbates this. Treatment of hyperphosphatemia is aimed at
lowering serum phosphate levels via two means: (1) restricting
dietary phosphorus intake; and (2) using, on a daily basis, and
with each meal, oral phosphate binding drugs that facilitate fecal
elimination of dietary phosphate rather than its absorption from
the gastrointestinal tract into the bloodstream.
About Oxylanthanum Carbonate
(OLC)
Oxylanthanum carbonate is a next-generation
lanthanum-based phosphate binding agent utilizing proprietary
nanoparticle technology being developed for the treatment of
hyperphosphatemia in patients with chronic kidney disease (CKD).
OLC has over forty issued and granted patents globally. Its
potential best-in-class profile may have meaningful patient
adherence benefits over currently available treatment options as it
requires a lower pill burden for patients in terms of number and
size of pills per dose that are swallowed instead of chewed. Based
on a survey conducted in 2022, Nephrologists stated that the
greatest unmet need in the treatment of hyperphosphatemia with
phosphate binders is a lower pill burden and better patient
compliance.1 The global market opportunity for treating
hyperphosphatemia is projected to be in excess of $2.5 billion in
2023, with the United States accounting for more than $1 billion of
that total. Despite the availability of several FDA-cleared
medications, 75 percent of U.S. dialysis patients fail to achieve
the target phosphorus levels recommended by published medical
guidelines.
Unicycive is seeking FDA approval of OLC via the
505(b)(2) regulatory pathway. As part of the clinical development
program, two clinical studies were conducted in over 100 healthy
volunteers. The first study was a dose-ranging Phase I study to
determine safety and tolerability. The second study was a
randomized, open-label, two-way crossover bioequivalence study to
establish pharmacodynamic bioequivalence between OLC and Fosrenol.
Based on the topline results of the bioequivalence study,
pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was
established.
About Unicycive
Therapeutics
Unicycive Therapeutics is a biotechnology
company developing novel treatments for kidney diseases.
Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a
novel investigational phosphate binding agent being developed for
the treatment of hyperphosphatemia in chronic kidney disease
patients on dialysis. UNI-494 is a patent-protected new chemical
entity in late preclinical development for the treatment of acute
kidney injury. For more information, please visit
www.unicycive.com.
Fosrenol® is a registered trademark of Shire
International Licensing BV.1Reason Research, LLC 2022 survey.
Results here.
Forward-looking
statementsCertain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
using words such as "anticipate," "believe," "forecast,"
"estimated" and "intend" or other similar terms or expressions that
concern Unicycive's expectations, strategy, plans or intentions.
These forward-looking statements are based on Unicycive's current
expectations and actual results could differ materially. There are
several factors that could cause actual events to differ materially
from those indicated by such forward-looking statements. These
factors include, but are not limited to, clinical trials involve a
lengthy and expensive process with an uncertain outcome, and
results of earlier studies and trials may not be predictive of
future trial results; our clinical trials may be suspended or
discontinued due to unexpected side effects or other safety risks
that could preclude approval of our product candidates; risks
related to business interruptions, which could seriously harm our
financial condition and increase our costs and expenses; dependence
on key personnel; substantial competition; uncertainties of patent
protection and litigation; dependence upon third parties; and risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties related to market conditions and other factors
described more fully in the section entitled ‘Risk Factors’ in
Unicycive’s Annual Report on Form 10-K for the year ended December
31, 2022, and other periodic reports filed with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Unicycive
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Investor Contact:
ir@unicycive.com(650) 900-5470
SOURCE: Unicycive Therapeutics, Inc.
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