Unicycive Therapeutics Provides Regulatory Update on Lanthanum Dioxycarbonate Program
29 Juni 2023 - 11:04PM
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage
biotechnology company developing therapies for patients with kidney
disease (the “Company” or “Unicycive”), today provided an update
based on recent interactions with the U.S. Food and Drug
Administration (FDA or Agency) concerning the Company’s New Drug
Application (NDA) for lanthanum dioxycarbonate (LDC), previously
known as Renazorb. LDC is an investigational new drug being
developed for the treatment of hyperphosphatemia in chronic kidney
disease patients on dialysis.
In preparation for its anticipated NDA filing
for LDC, the Company requested a pre-NDA meeting with the FDA to
align on the contents of the NDA. As previously noted, the Agency
had requested a 6-month toxicity study in mice comparing LDC and
lanthanum carbonate (LC), the drug substance in Fosrenol®, the
Reference Listed Drug for the 505(b)(2) regulatory pathway. The
study report was submitted to the Agency as part of the pre-NDA
meeting package showing that there was no evidence of any
gastrointestinal (GI) neoplasms for either LC- or LDC-dosed mice.
However, upon review of the study report, the Agency pointed out
that although the GI adverse findings observed with LDC are
qualitatively similar to lanthanum carbonate, there were
quantitative differences.
Based on the review of this information, the FDA
has asked the Company to provide additional information, including
risk assessment and clinical data, to evaluate the tolerability of
LDC in patients with chronic kidney disease on dialysis. The
Company requested a follow-up meeting with the FDA to discuss its
additional requests.
“We will work diligently to gain alignment with
the FDA on the additional data requirements and plan to provide
further updates regarding the program in the third quarter of this
year,” stated Shalabh Gupta, MD, CEO of Unicycive. “We remain
undeterred in our enthusiasm for the potential best-in-class
profile of LDC and are dedicated to bringing this important new
treatment option to patients as soon as possible.”
Unicycive is seeking FDA approval of LDC 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 LDC and Fosrenol.
Based on the topline results of the bioequivalence study,
pharmacodynamic (PD) bioequivalence of lanthanum dioxycarbonate 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.
About Lanthanum Dioxycarbonate
(LDC)
Lanthanum dioxycarbonate 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).
LDC 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.
About Unicycive
Therapeutics
Unicycive Therapeutics is a biotechnology
company developing novel treatments for kidney diseases.
Unicycive’s lead drug candidate, lanthanum dioxycarbonate (LDC), 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 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) 900-5470
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