Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 by the U.S. Food and Drug Administration for the Prevention of Delayed Graft Function in Kidney Transplant Patients
March 04 2024 - 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 that the
U.S. Food and Drug Administration has granted orphan drug
designation (ODD) to UNI-494 for the prevention of Delayed Graft
Function (DGF) in kidney transplant patients. UNI-494 is a
cytoprotective agent that elicits an ischemic preconditioning
effect by activating KATP channels in mitochondria to restore
mitochondrial function.
“We are pleased to announce that the FDA has
granted orphan drug designation to UNI-494 for the prevention of
delayed graft function after kidney transplantation, an unmet
medical need for which there are no FDA-approved drugs,” said
Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Obtaining
ODD is an important milestone in the development of UNI-494 that
may provide certain tax credits for qualified clinical trials,
exemption of user fees, and the potential for seven years of market
exclusivity after approval. DGF is one of the most serious
complications resulting from kidney transplantation, and we believe
that the mechanism of action of UNI-494 is ideally suited for the
prevention of this orphan condition.”
The FDA, through its Office of Orphan Products
Development (OOPD), grants orphan drug designation to agents that
have the potential to offer a safe and effective treatment,
diagnosis or prevention of rare diseases that affect fewer than
200,000 individuals in the United States.
As previously announced, on March 12, 2024,
Unicycive will present data on the efficacy of UNI-494 in animal
models of DGF and a poster describing the ongoing Phase 1 clinical
trial design for UNI-494 in healthy volunteers at the 29th
International Conference on Advances in Critical Care Nephrology
AKI and CRRT 2024.
About Delayed Graft
Function
Delayed Graft Function (DGF) refers to the acute
kidney injury (AKI) that occurs in the first week after kidney
transplantation, which necessitates dialysis intervention. As the
name indicates, DGF can result in sub-optimal or impaired graft
function and is one of the most common and serious complications of
kidney transplantation. Poor kidney function in the first week of
graft life is detrimental to the longevity of the allograft. DGF is
also associated with higher rates of tissue rejection and decreased
patient survival. Currently, there are no FDA approved drugs for
the treatment of DGF.
Ischemia/reperfusion injury (IRI) is known to be
a major causative factor for the AKI that results in DGF during
kidney transplantation. Ischemic preconditioning, that works by
activating KATP channels in mitochondria, is a natural endogenous
mechanism which protects cells from IRI in the heart, kidney,
liver, and other organs. UNI-494 is a pharmacological approach that
emulates and enhances this natural phenomenon of ischemic
preconditioning.
About UNI-494
UNI-494 is a novel nicotinamide ester derivative
and a selective ATP-sensitive mitochondrial potassium channel
activator. Mitochondrial dysfunction plays a critical role in the
progression of acute kidney injury and chronic kidney disease.
UNI-494 has a novel mechanism of action that restores mitochondrial
function and may be beneficial for the treatment of several
diseases including kidney disease. Unicycive is currently
conducting a Phase 1 dose-ranging safety study in healthy
volunteers in the United Kingdom that is expected to complete in 2H
of 2024. UNI-494 is protected by issued patent(s) in the U.S. and
Europe and a wide range of patent applications worldwide.
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 clinical development for the treatment of conditions
related to acute kidney injury. For more information, please
visit Unicycive.com and follow us on LinkedIn and YouTube.
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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