Alebund Pharmaceuticals Receives FDA IND Clearance for AP308 in IgA Nephropathy

AP308 Moves Into Clinical Development

Alebund Pharmaceuticals has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for AP308.

AP308 is an investigational engineered recombinant IgA protease being developed for IgA nephropathy (IgAN), a kidney disease that can cause progressive kidney damage.

The FDA clearance allows Alebund to move AP308 from preclinical research into clinical development. The company plans to start clinical trials in the near term.

For Alebund, the IND clearance is an important step because AP308 is the company’s first-in-class approach designed to directly target disease-causing IgA and IgA immune complexes that have already accumulated in the kidney.

What Is IgA Nephropathy?

IgA nephropathy is a kidney disease in which IgA-containing immune complexes build up in the glomeruli.

The glomeruli are tiny blood-filtering structures inside the kidneys. When abnormal IgA deposits collect there, they can trigger inflammation and gradually damage the kidneys.

Patients may experience blood or protein in the urine, high blood pressure and declining kidney function. In some patients, the disease can eventually lead to end-stage kidney disease.

IgA nephropathy is considered the most common primary glomerulonephritis worldwide.

A Significant Unmet Need for IgAN Patients

Current treatments for IgA nephropathy mainly focus on reducing the production of IgA, controlling inflammation or protecting kidney function.

However, these approaches do not necessarily remove IgA immune complexes that have already been deposited in the kidneys.

This is the area Alebund is targeting with AP308.

According to data cited by the company, long-term kidney outcomes remain a concern for people with IgA nephropathy despite current treatment strategies.

Long-term studies from China and the United Kingdom have reported median kidney survival of about 11 to 12 years. Many patients can progress to end-stage renal disease within 10 to 15 years after diagnosis.

Alebund also cites estimates from China Insights Consultancy showing that approximately 9.5 million people worldwide had IgA nephropathy in 2025. China accounted for about 5.1 million of these patients, making it the largest IgAN patient population globally.

What Is AP308?

AP308 is an engineered recombinant IgA protease.

The drug is based on an IgA protease originally derived from Thomasclavelia ramosa, a bacterium that can naturally live in the human body.

The basic idea behind AP308 is straightforward. The treatment is designed to break down disease-causing IgA molecules and immune complexes.

It can cleave several forms of IgA, including IgA1, galactose-deficient IgA1, polymeric IgA and IgA immune complexes.

The drug is also designed to help clear IgA immune complexes and complement C3 deposits that are already present in the glomeruli.

In preclinical studies, the protease acted within minutes and did not affect other major immunoglobulins such as IgG and IgM.

AP308 Is Designed to Target Existing Kidney Deposits

One of the main differences in the AP308 approach is where the treatment is expected to act.

Many IgAN treatments are designed to reduce the amount of abnormal IgA being produced or to control the inflammation caused by the disease.

AP308 is being developed to directly break down the harmful IgA and immune complexes that have already accumulated in the kidneys.

This could potentially provide a different way of treating IgA nephropathy.

The company is developing AP308 with the aim of achieving what it describes as a functional cure for IgAN, although this will need to be tested in clinical trials.

Alebund Developed AP308 Using Its Protease Engineering Platform

Alebund began working with Peking University First Hospital in January 2022 to explore the development of IgA proteases as potential treatments for IgA nephropathy.

The company subsequently entered into a license agreement with Peking University First Hospital.

Alebund then used its proprietary Long-Acting Protease Engineering Platform to develop and nominate AP308 as a drug candidate.

The platform is designed to improve the stability and developability of protease-based medicines.

It is also intended to extend the drug's circulating half-life, reduce renal clearance and lower immunogenicity while maintaining its ability to cleave IgA1.

This could allow AP308 to be developed as a long-acting treatment that requires less frequent dosing.

Alebund holds the global rights to develop, manufacture and commercialize AP308.

Preclinical Studies Showed Reduction in IgA Deposits

Before moving into clinical development, AP308 was tested in preclinical models of IgA nephropathy.

In a humanized mouse model, animals received AP308 once a week for eight weeks through subcutaneous administration.

The treatment reduced circulating human IgA and IgA immune complexes by approximately 80% compared with control animals.

At the end of the treatment period, researchers found that IgA deposits in the glomeruli had almost completely cleared.

The animals also showed a significant reduction in proteinuria, which is the presence of excess protein in the urine and an important sign of kidney damage.

Kidney tissue also showed marked improvements in disease-related changes.

Single Dose Cleared Existing Deposits in Another Model

Researchers also evaluated AP308 using a separate pre- and post-treatment study design.

In this model, a single dose of AP308 completely cleared pre-existing chronic IgA and complement C3 deposits from the glomeruli within seven days.

This finding is particularly relevant to the way AP308 is being developed.

The drug is not only being tested as a way to reduce newly forming IgA deposits. It is also being investigated for its ability to remove deposits that are already present in the kidneys.

These results were published in May 2026 in Kidney International, the official journal of the International Society of Nephrology.

Safety Findings From Preclinical Studies

The preclinical studies also evaluated the safety of repeated AP308 dosing.

According to the company, repeated administration did not produce signals of liver or kidney toxicity.

Researchers also did not observe a significant increase in anti-drug antibody levels following repeated treatment.

These findings provided additional support for moving AP308 into clinical development.

Human clinical studies will now be needed to understand the safety, tolerability and effectiveness of the treatment in people with IgA nephropathy.

FDA IND Clearance Opens the Path to Human Trials

The FDA's IND clearance means Alebund can move forward with clinical testing of AP308 in the United States.

The company has said that it plans to initiate the clinical trial in the near term.

The upcoming clinical program will be important for determining whether the promising activity seen in preclinical models can translate into meaningful benefits for patients.

Researchers will need to evaluate factors such as safety, appropriate dosing, pharmacokinetics and the treatment's effect on IgA levels and kidney disease.

Alebund Builds a Kidney-Focused Drug Pipeline

AP308 is part of Alebund Pharmaceuticals' broader focus on kidney disease and related chronic conditions.

The company currently has seven investigational drug candidates and one commercialized product, Mircera.

Three of its investigational candidates are already in clinical development.

AP301 has completed a pivotal Phase III trial in China, with its New Drug Application accepted for review by China's National Medical Products Administration. A global multi-regional clinical trial is also ongoing.

AP306 is in Phase II development, while AP303 is in Phase I development.

The pipeline covers several kidney-related conditions, including chronic kidney disease, renal anemia, hyperphosphatemia, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis and autosomal dominant polycystic kidney disease.

Manufacturing and Commercial Infrastructure in China

Alebund has also been building infrastructure to support its pipeline.

The company has established a manufacturing site in Yangzhou, Jiangsu, which is intended to support future commercial manufacturing of AP301 and other pipeline products.

The site has obtained a Category B Drug Manufacturing License from the Jiangsu Provincial Drug Administration.

Alebund has also established a dedicated nephrology sales team to support the commercialization of relevant products in China.

What Comes Next for AP308?

With FDA IND clearance now in place, Alebund is preparing to take AP308 into human clinical development.

The upcoming clinical trials will provide the first opportunity to evaluate the engineered IgA protease directly in patients with IgA nephropathy.

The company will be looking to determine whether AP308 can safely reduce disease-causing IgA, clear kidney deposits and potentially slow or improve kidney damage.

The clinical program will also help establish the dosing schedule for the long-acting treatment approach developed through Alebund's protease engineering platform.

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