Unicycive Therapeutics, Inc.

Chronic Kidney Disease is a very significant issue across much of the world. According to Research and Markets, the global end stage renal disease (ESRD) market size is anticipated to reach over $260 billion by 2030, leading to a very robust Compound Annual Growth Rate (CAGR) of 12.9% from 2022 to 2030. An increasing number of patients suffering from kidney failure, the rapid increase in the volume of hospitals & urgent care centers, and growing hospital admission rates are thought to be the catalysts behind this growth. Both of the company's programs have the potential to participate in this market.

Unicycive Therapeutics' lead program, Oxylanthanum Carbonate (OLC), is designed to address hyperphosphatemia, a condition characterized by elevated phosphate levels in patients with chronic kidney disease undergoing dialysis. The global hyperphosphatemia treatment market was estimated to be $2.5 billion in 2021. With a projected Compound Annual Growth Rate (CAGR) of 5.3% between 2021 and 2028, the current market may be close to $3.0 billion, highlighting a significant opportunity for Unicycive's OLC.

Go-to-Market Strategy and Partnerships:

Unicycive's go-to-market strategy involves strategic partnerships to expand the reach and accelerate the commercialization of Oxylanthanum Carbonate. In Q4 2022, Unicycive entered an agreement with Lee's Pharmaceutical (HK) Limited, granting exclusive rights to develop, market, and commercialize OLC in Mainland China, Hong Kong, and certain Asian markets. This agreement provides Unicycive with a strong local partner with deep domain expertise, unlocking significant growth potential in one of the largest markets for kidney disease patients.

As part of the agreement, Unicycive received an upfront payment of $1.0 million and is eligible for royalties on sales and other milestone payments. This strategic partnership enhances Unicycive's presence in Asia, providing a strong platform for future growth.

Unicycive continues to explore additional partnership opportunities in Asia and Europe to further expand its market presence and accelerate the commercialization of Oxylanthanum Carbonate. The company aims to establish a global network of strategic partners to bring innovative treatments to patients with kidney disease worldwide.

Source: Company Documents

As with any company focusing on creating solutions for health issues, navigating the regulatory maze is critical for success. Unicycive has demonstrated a strong ability to do so.

OXYLANTHANUM CARBONATE:
The company's lead program, Oxylanthanum Carbonate (OLC), is on a significantly de-risked regulatory pathway for commercialization. In a Type C meeting with the FDA in Q4 2021, the company received clear guidance to file a New Drug Application (NDA). Unicycive is pursuing a 505(b)(2) pathway for U.S. approval, leveraging pre-clinical and clinical data from the approved lanthanum-containing phosphate binder, Fosrenol. This pathway allows the company to skip certain clinical trial phases, streamlining the approval process.

The company conducted a bioequivalence (B.E.) study comparing urinary phosphorus changes between OLC and Fosrenol in healthy volunteers and a 6-month oral toxicity study in mice. The results showed that OLC met all endpoints, indicating its safety and efficacy. Additionally, the company completed standard studies on manufacturability and commercial supply readiness. Unicycive completed the B.E. study with volunteers in Q4 2022. The company's NDA was submitted in August 2024 and accepted in November 2024. Unicycive projects a PDUFA Date for FDA Approval of June 28, 2025, and a commercial launch anticipated in H2 2025.

FDA Regulatory Strategy

• 505(b)(2) regulatory pathway for the potential U.S. approval of OLC.

• Leverage pre-clinical and clinical data from Fosrenol to support NDA.

• Bioequivalence study in healthy volunteers comparing urinary phosphorus changes between OLC and Fosrenol.

• 6-month oral toxicity study in mice.

• Treatment-emergent adverse events were comparable between the OLC and Fosrenol groups, with no serious adverse events or deaths reported. 

Commercial strategy

• Product positioning, market access, and market shaping activities are ongoing to optimize the value proposition.

• Pursuing a parallel commercial model to address the concentrated nephrology market, including partnerships with pharmaceutical companies, license and/or distribution agreements with dialysis organizations, and outsourced contract sales organizations. 

*OLC is an unapproved investigational new drug being developed under FDA’s 505(b)(2 ) regulatory procedure. If approved, OLC will share the same product label and prescribing information as the approved reference-listed drug (RLD) Fosrenol, with the advantage of smaller, immediate-release tablets that are swallowed whole and not chewed.

UNI-494

Unicycive's other program, UNI-494, is also positioned well for a shorter approval timeframe. As a novel pro-drug of a marketed agent, nicorandil, it uses an established legacy with known MOAs and demonstrated safety and efficacy with its use of nitric oxide. It uses a known and safe chemical linker, and its controlled release of the active drug in plasma may enable once-daily QD dosing. 

To expedite the process, the clinical development of UNI-494 began in the United Kingdom (U.K.). The company filed a Clinical Trial Application (CTA) with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. to initiate a Phase I healthy volunteer study. In addition, Unicycive filed an Investigational New Drug (IND) application with the FDA. A Method of Use patent was granted by the USPTO, and successful Phase 1 study results were published in October 2024. The company anticipates that UNI-494 will advance to a Phase 2 Proof of Concept (POC) Study in 2025.

While nothing is guaranteed during this process, Unicycive Therapeutics is taking intelligent steps that could lead to commercialization in a shorter timeframe compared to many other companies in the industry.

Source: Company Documents

Unicycive Therapeutics focuses on developing drug candidates for serious kidney diseases. Its lead program, Oxylanthanum Carbonate (OLC), aims to address the challenging problem of uncontrolled hyperphosphatemia with a patient-friendly solution. This serious complication often affects patients undergoing dialysis and can lead to significant health risks if not managed effectively.

Source: Company Documents

• Oxylanthanum Carbonate (OLC) is a novel phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD).

• The mechanism of action involves binding to dietary phosphate in the gastrointestinal (GI) tract, which is then excreted via the feces, resulting in reduced serum phosphate levels.

• Unicycive's proprietary nanotechnology allows more active medication to be packed into smaller pills, offering greater convenience and efficacy for patients.

• Key Features of OLC

  • Enhanced surface area due to proprietary nanotechnology

  • Lower molecular weight

  • Immediate-release tablets

  • Smaller pills that are swallowed whole (Not Chewed)

UNI-494 is Unicycive Therapeutics' other program, targeting Acute Kidney Injury (AKI). This drug is designed to focus on mitochondria—the "powerhouse of the cell"—which play a critical role in energy production and cellular health. Mitochondrial dysfunction can lead to kidney damage, which UNI-494 aims to address by regulating mitochondrial activity.

Source: Company Documents

• A hallmark feature of mitochondrial dysfunction is the chronic opening of MPT Pores and the overproduction of Reactive Oxygen Species (ROS)

• Chronic opening of MPT Pore leads to water and solute influx, injury, and subsequent death

• UNI-494 is an ATP-sensitive K channel (KATP) activator

• Binds to SUR2 subunit of KATP channel that, in turn, leads to closing of MPT pores

• Nicorandil down-regulates the production of ROS

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