Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage
biotechnology company developing therapies for patients with kidney
disease (the “Company or “Unicycive”), today announced the Company
has reached alignment with the U.S. Food and Drug Administration
(FDA) on the path forward for Oxylanthanum Carbonate (OLC) and on
the overall package requirements to file a New Drug Application.
As reported in June, in the pre-NDA package
shared with the FDA, the Agency requested clinical data in patients
to proceed with the filing. Recently, during a Type C meeting with
the FDA, the Company and the Agency reached an agreement on the
overall data package requirements to file the NDA including
clinical data, preclinical data, and CMC (chemistry, manufacturing,
and controls). As a reminder, Unicycive intends to file the OLC NDA
utilizing the 505(b)(2) regulatory pathway to reference the
currently approved drug, Fosrenol®.
In the Type C meeting, plans were confirmed with
the FDA for the pivotal clinical trial. The Agency agrees with
the Company's study design of 60 participants to be evaluated for 4
weeks on OLC once participants are titrated to clinically effective
doses. The study is designed to evaluate tolerability and the event
rate for discontinuation; therefore, there is no statistical
analysis required to demonstrate efficacy. No other clinical study
is required. We believe that results from this pivotal trial will
enhance our safety data package from preclinical studies, and the
efficacy data is referenced with Unicycive’s previously disclosed
bioequivalence study.
“By working closely with the FDA, we have clear
visibility into the requirements to file a full NDA data package
for potential approval of OLC,” said Shalabh Gupta, MD, Chief
Executive Officer of Unicycive. “The alignment with the FDA
includes all elements of our planned NDA package including
clinical, preclinical, and CMC requirements. We expect to initiate
the pivotal trial for OLC before the end of this year, with top
line data expected in the second quarter of 2024. Once we complete
the trial, we plan to finalize the NDA package and submit to the
FDA.”
As of June 30, 2023, Unicycive’s cash position
was reported as $18.8 million which is expected to last into the
second half of 2024 including the ability to start and complete the
pivotal clinical trial.
The planned clinical trial is expected to be an
open-label, single-arm, multicenter, multidose study to evaluate
the tolerability of clinically effective doses of OLC in
participants with chronic kidney disease (CKD) on dialysis. As a
reminder, all approved phosphate binders, including Fosrenol, are
administered to patients on a dose titration schedule based on the
control of serum phosphate. In Unicycive’s clinical trial, once
participants have been titrated to a clinically effective dose with
a serum phosphate range of ≤5.5 mg/dL, they will be treated for
four weeks to evaluate serum phosphate levels.
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.
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.
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) 543-5470
SOURCE: Unicycive Therapeutics, Inc.
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