Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis
December 18 2023 - 7:03AM
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage
biotechnology company developing therapies for patients with kidney
disease (the “Company or “Unicycive”), today announced the
enrollment of the first patient in its open-label, single-arm,
multicenter, multidose pivotal clinical trial with Oxylanthanum
Carbonate (OLC). OLC 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) on dialysis.
“The initiation of patient enrollment in our OLC
pivotal clinical trial is a critical milestone as we strive to
reduce the pill burden and improve quality of life for individuals
with chronic kidney disease on dialysis,” said, Shalabh Gupta, MD,
Chief Executive Officer of Unicycive. “OLC’s novel characteristics
have the potential to make it the best-in-class phosphate binder in
the billion-dollar hyperphosphatemia market. Data from this pivotal
trial is the last major component to complete our data package to
file a New Drug Application (NDA) and will be informative for
physicians as they consider a new potential therapy for their
patients. We expect to report data from the trial in the second
quarter of 2024 and file the NDA shortly thereafter.”
The primary endpoint for the study will evaluate
the tolerability of clinically effective doses of OLC in patients
with CKD on dialysis. The secondary endpoints will evaluate safety
and pharmacokinetics. There is no statistical analysis required to
demonstrate efficacy as bioequivalence to Fosrenol® was previously
established; and there is no other clinical study required to
submit an NDA under the 505(b)(2) regulatory pathway.
The trial is expected to enroll 60 evaluable
participants. Once participants are enrolled into the trial, they
will go through a washout period for two weeks to clear their
current phosphate binder from their system. Participants will
initially be dosed at 500 mg of OLC three times a day (TID) and be
titrated to a clinically effective dose that is defined as the dose
required to achieve a serum phosphate range of ≤5.5 mg/dL. The
maximum dose of OLC tested will be 3000 mg/day (1000 mg TID). As a
reminder, all approved phosphate binders, including Fosrenol, are
administered on a dose titration schedule based on the control of
serum phosphate. Once titrated to a clinically effective dose,
participants will then be treated for four weeks to evaluate serum
phosphate levels.
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) on
dialysis. 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 more than 100
healthy subjects. 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 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.
Fosrenol® is a registered trademark of Shire
International Licensing BV.1Reason Research, LLC 2022 survey.
Results here.
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
Unicycive.com and follow us on LinkedIn and YouTube.
Forward-looking statements
Certain 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) 543-5470
SOURCE: Unicycive Therapeutics, Inc.
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