Quince Therapeutics Announces Positive Clinical Improvements in Phase 2 Trial of LAM-001

Quince Therapeutics, a late-stage biotechnology company focused on developing innovative therapies for severe pulmonary diseases, has announced encouraging new findings from its Phase 2a clinical trial evaluating LAM-001, an investigational inhaled sirolimus therapy. The study focused on patients suffering from pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The newly released data demonstrated clinically meaningful improvements across several important health markers, including exercise capacity, pulmonary vascular resistance, lung function, and cardiac stress biomarkers. The company stated that these findings support the continued development of LAM-001 as a potential disease-modifying treatment for pulmonary hypertension-related diseases.

Strong Improvements Observed Across Multiple Clinical Measures

According to the Phase 2a study results, patients receiving LAM-001 alongside standard-of-care therapies showed measurable improvements in several clinically relevant endpoints after 24 weeks of treatment.

Key Clinical Improvements Included:

• Increase in six-minute walk distance (6MWD), indicating improved exercise capacity
• Reduction in pulmonary vascular resistance (PVR), suggesting better blood flow through the lungs
• Decrease in NT-proBNP levels, a biomarker associated with cardiac stress
• Improved forced vital capacity (FVC), reflecting healthier lung function
• Improved WHO Functional Class status, showing enhanced daily physical capability

The trial included six evaluable patients overall, four of whom were diagnosed with PH-ILD. All PH-ILD participants were already receiving stable background therapy with treprostinil prior to and throughout the study.

Detailed Trial Results Highlight Clinical Potential

The Phase 2a data revealed significant gains in exercise performance and cardiopulmonary function.

Results From the Evaluable Population (N=6)

• 6MWD: +81.3 meters
• VO2 Max: +5.4%
• Exercise PVR: -25.5%
• Supine PVR: -28.1%
• NT-proBNP: -29.0%
• FVC: +4.8%

Results From the PH-ILD Subgroup (N=4)

• 6MWD: +67.4 meters
• VO2 Max: +6.7%
• Exercise PVR: -35.3%
• Supine PVR: -33.9%
• NT-proBNP: -28.8%
• FVC: +1.8%

Importantly, all evaluable patients improved from WHO Functional Class III to Functional Class II by Week 24, suggesting meaningful progress in symptom severity and quality of life. Additionally, two patients achieved Functional Class I status during longer-term follow-up evaluations.

Medical Experts Highlight Encouraging Outcomes

Dr. Aaron B. Waxman, Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital and Associate Professor of Medicine at Harvard Medical School, commented positively on the findings.

He noted that patients with PH-ILD continue to experience substantial health burdens despite currently available therapies. Dr. Waxman emphasized that the consistency of improvement observed across exercise capacity, pulmonary hemodynamics, cardiac biomarkers, and lung function could represent an important advancement for the pulmonary hypertension community.

He also explained that improvements in endpoints such as 6MWD and pulmonary vascular resistance are particularly significant because they are commonly used markers in pulmonary hypertension clinical trials and regulatory evaluations.

About LAM-001: A Novel Inhaled Sirolimus Therapy

LAM-001 is an investigational, once-daily inhaled formulation of sirolimus, also known as rapamycin. The therapy is specifically designed to deliver medication directly into the lungs while minimizing systemic exposure throughout the body.

The treatment targets the mTOR signaling pathway, which has been linked to abnormal smooth muscle cell proliferation and vascular remodeling in pulmonary hypertension.

Potential Benefits of LAM-001 Include:

• Reducing pulmonary artery remodeling
• Improving blood vessel function in the lungs
• Suppressing inflammation and fibrosis
• Lowering cardiopulmonary stress
• Enhancing exercise tolerance and lung capacity

Researchers believe that inhibiting the mTOR pathway may help reverse some of the underlying disease processes associated with pulmonary hypertension and interstitial lung disease.

Why PH-ILD Remains a Serious Unmet Medical Need

PH-ILD is a severe and progressive condition that combines pulmonary hypertension with interstitial lung disease. Patients often experience worsening shortness of breath, exercise intolerance, reduced oxygen levels, and declining lung function.

Despite existing treatment options, many patients continue to deteriorate over time, highlighting the urgent need for new therapeutic approaches.

According to company estimates, PH-ILD affects approximately:

• 86,000 patients in the United States
• 120,000 patients in Europe

The condition is associated with high morbidity and limited long-term survival, making successful new treatments especially important.

Next Steps: Phase 2b Trial Planned for Mid-2026

Following the encouraging Phase 2a results, Quince Therapeutics plans to advance LAM-001 into a larger Phase 2b clinical trial focused specifically on PH-ILD patients.

The company expects to begin the Phase 2b study in mid-2026, with topline data anticipated during the first quarter of 2028.

Researchers hope the next-stage study will further confirm the therapy’s safety profile and therapeutic benefits in a broader patient population.

Safety and Tolerability Findings

In addition to efficacy improvements, LAM-001 was reported to be generally well tolerated during the Phase 2a trial.

No unexpected safety concerns were highlighted in the released data. Patients continued receiving background standard-of-care therapies throughout treatment, demonstrating that LAM-001 may potentially integrate into existing pulmonary hypertension treatment regimens.

Growing Interest in Innovative Pulmonary Hypertension Therapies

The pulmonary hypertension treatment landscape continues to evolve rapidly as biotechnology companies and researchers search for therapies capable of slowing disease progression rather than simply managing symptoms.

Several investigational treatments are currently being studied for PH-ILD and related pulmonary vascular diseases. However, LAM-001’s combination of functional, hemodynamic, biomarker, and lung function improvements has attracted significant attention within the medical community.

The findings were also presented at the American Thoracic Society (ATS) 2026 Conference, where experts discussed the growing need for disease-modifying therapies in pulmonary vascular medicine.

About Quince Therapeutics

Quince Therapeutics, Inc. is a biotechnology company focused on developing innovative therapies for rare and serious diseases. The company’s research pipeline includes treatments targeting pulmonary diseases and neurological disorders using advanced drug delivery technologies.

Quince Therapeutics continues to expand its clinical development programs with the goal of addressing major unmet medical needs in specialized patient populations.

More information can be found on the company’s official website at.

The full original announcement was published through.

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