Unicycive Therapeutics Granted Patent on UNI-494 to Treat Acute Kidney Injury by the United States Patent and Trademark Office (USPTO)
Unicycive Therapeutics (Nasdaq: UNCY) has been granted U.S. Patent No. 12,036,211 by the USPTO for UNI-494, ensuring intellectual property protection until 2040. The patent covers a method of treating acute kidney injury or contrast-induced nephropathy using the UNI-494 compound, a novel nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator.
UNI-494 is currently in a Phase 1 clinical trial and has received Orphan Drug Designation for Delayed Graft Function, a form of acute kidney injury. This patent is a important component of Unicycive's strategy to become a leader in developing drugs targeting kidney disease.
- Granted U.S. Patent No. 12,036,211 for UNI-494
- Patent protection secured until 2040
- UNI-494 in ongoing Phase 1 clinical trial
- Received Orphan Drug Designation for Delayed Graft Function
- None.
Insights
The issuance of the patent for UNI-494 is significant as it grants Unicycive Therapeutics intellectual property protection until 2040 for the treatment of acute kidney injury (AKI) and contrast-induced nephropathy. This type of protection can be important in the pharmaceutical industry, where the development pipeline is long and expensive. By securing this patent, Unicycive can safeguard their investment in UNI-494 and potentially prevent competitors from developing similar treatments for a significant period.
UNI-494's designation as a selective ATP-sensitive mitochondrial potassium channel activator addresses mitochondrial dysfunction, a key factor in kidney disease progression. This positions the drug uniquely in the therapeutic landscape for AKI, which remains an area with limited effective treatments. The ongoing Phase 1 clinical trial and recent Orphan Drug Designation for Delayed Graft Function suggest that the company is making promising strides in this niche area.
From a financial standpoint, the patent issuance is a positive indicator for Unicycive Therapeutics. Patents often translate to higher market valuations due to the competitive advantage and market exclusivity they confer. For investors, this could mean potential long-term returns as the market often reacts favorably to companies that secure their intellectual property, especially when dealing with unmet medical needs like those in kidney disease.
Additionally, the patent aligns with Unicycive's broader strategic goals. It enhances their drug portfolio, potentially attracting partnerships or licensing deals, which can be lucrative revenue streams. With the company still in the clinical stages, milestones like these are critical for maintaining investor confidence and securing funding for future trials.
The issuance of this patent also has broader implications in the market for kidney disease treatments. The extension of intellectual property rights until 2040 places Unicycive in a potentially strong market position for the long haul. Investors should note that the AKI market is currently valued at around $1 billion and is expected to grow. Unicycive's strategic positioning with UNI-494 could give it a competitive edge as demand for effective AKI treatments increases.
However, it's important to monitor the progress of UNI-494 through its clinical phases. The market's reaction will heavily depend on the outcomes of these trials and the drug's subsequent efficacy and safety profiles. While the patent is a significant milestone, the real impact will be determined by the clinical success and market acceptance of UNI-494.
Ensures Intellectual Property Protection Until 2040
LOS ALTOS, Calif., July 17, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent No. 12,036,211 by the United States Patent and Trademark Office (USPTO) for UNI-494.
The patent, valid until 2040, secures protection of a method of treating a disease or a condition selected from acute kidney injury or contrast induced nephropathy by administering the UNI-494 compound. The UNI-494 compound covered in the method of use claims is not limited to a particular salt, dose or type of administration. 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.
"We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This patent helps protect our approach and expands our portfolio as we look to develop novel treatments for kidney diseases.”
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 the second half of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
About Acute Kidney Injury
Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined on the basis of increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7
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, X, 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, 2023, 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.
FAQ
What patent did Unicycive Therapeutics (UNCY) receive for UNI-494?
How long is the patent protection for Unicycive's UNI-494?
What is the current development stage of UNI-494 by Unicycive (UNCY)?
Has UNI-494 received any special designations from regulatory authorities?
