Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Rhea-AI Summary

Unicycive Therapeutics (Nasdaq: UNCY) has submitted a New Drug Application (NDA) to the FDA for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The company is seeking approval via the 505(b)(2) regulatory pathway, aiming to provide a differentiated, best-in-class therapy with reduced pill burden. The NDA is based on data from three clinical studies, preclinical studies, and CMC specifications.

Notably, the FDA granted a waiver for the NDA application PDUFA fees, saving Unicycive approximately $4 million. The company is now preparing for a potential market launch, pending FDA approval. This submission marks a significant milestone in Unicycive's mission to improve treatment options for CKD patients with hyperphosphatemia.

Positive

• Submission of NDA to FDA for Oxylanthanum Carbonate (OLC)
• FDA granted waiver for PDUFA fees, saving approximately $4 million
• Potential for differentiated, best-in-class therapy with reduced pill burden
• Preparation for market launch underway, pending FDA approval

Negative

• None.

Insights

Medical Research Analyst

The submission of an NDA for Oxylanthanum Carbonate (OLC) is a significant milestone for Unicycive Therapeutics. This potential treatment for hyperphosphatemia in CKD patients on dialysis could address a critical need in nephrology. The 505(b)(2) regulatory pathway chosen may expedite the approval process, leveraging existing data. The waiver of PDUFA fees, saving $4 million, is financially beneficial for the company.

The NDA package's comprehensiveness, including three clinical studies and extensive preclinical data, strengthens the application. If approved, OLC could offer a reduced pill burden for patients, potentially improving adherence and quality of life. However, it's important to note that FDA approval is not guaranteed and the review process typically takes 10-12 months.

Financial Analyst

Unicycive's NDA submission for OLC represents a pivotal moment for the company's financial outlook. The $4 million savings from the PDUFA fee waiver is significant for a clinical-stage biotech, potentially extending their cash runway. If approved, OLC could generate substantial revenue in the dialysis market, which is projected to grow.

Investors should note that while this news is positive, commercialization costs and potential competition could impact future profitability. The company's ability to successfully launch and market OLC, if approved, will be crucial. Additionally, the timeline for potential revenue generation should be considered, as the FDA review process and subsequent market penetration will take time.

Nephrology Expert

The development of OLC addresses a persistent challenge in managing CKD patients on dialysis. Hyperphosphatemia is associated with increased mortality and morbidity, making effective phosphate binders crucial. The potential for OLC to provide phosphate control with a reduced pill burden could significantly improve patient compliance and outcomes.

Current phosphate binders often require patients to take multiple pills several times a day, leading to poor adherence. If OLC can deliver effective phosphate control with fewer pills, it could become a preferred option for both patients and healthcare providers. However, it's important to await the full clinical data and FDA review to assess OLC's efficacy and safety profile compared to existing treatments.

LOS ALTOS, Calif., Sept. 03, 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 that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway.

“With this NDA submission, we are excited to be one step closer to our goal of bringing OLC to patients with chronic kidney disease who are living with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe our data support a differentiated and best-in-class therapy that will maintain phosphate control while reducing the onerous pill burden patients currently have to manage. Over the last several months, our team has worked diligently to reach this milestone, and we are now preparing to launch OLC, if approved. We are also pleased to report that the FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees which is a significant savings of approximately $4 million.”

The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC).

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 expected to exceed $2.5 billion, with the United States accounting for more than $1 billion of that total². 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.

Fosrenol® is a registered trademark of Shire International Licensing BV.
¹Reason Research, LLC 2022 survey. Results here.
²Fortune Business Insights^TM, Hyperphosphatemia Treatment Market, 2021-2028 

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 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 is the purpose of Unicycive's (UNCY) New Drug Application for Oxylanthanum Carbonate?

Unicycive Therapeutics has submitted an NDA for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease patients on dialysis, aiming to provide a therapy with reduced pill burden.

How much did Unicycive (UNCY) save on FDA fees for the Oxylanthanum Carbonate NDA?

The FDA granted Unicycive a waiver for the NDA application PDUFA fees, resulting in savings of approximately $4 million.

What clinical data supports Unicycive's (UNCY) NDA for Oxylanthanum Carbonate?

The NDA is based on data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis, along with preclinical studies and CMC specifications.

What regulatory pathway is Unicycive (UNCY) using for the Oxylanthanum Carbonate NDA?

Unicycive is seeking FDA approval for Oxylanthanum Carbonate (OLC) via the 505(b)(2) regulatory pathway.