Key Points:

• Vicore Pharma is spearheading innovative solutions for idiopathic pulmonary fibrosis (IPF) with buloxibutid, an angiotensin II type 2 receptor agonist (ATRAG), aimed at stabilizing and improving lung function in IPF patients, addressing the significant unmet need for effective therapies in this progressive lung disease. 
• At the forefront of respiratory disease research, Vicore Pharma presents groundbreaking findings at the 2024 American Thoracic Society (ATS) International Conference, highlighting the promising outcomes of the Phase IIa AIR trial and the patient-centric design of the upcoming Phase IIb ASPIRE trial, signaling hope for enhanced IPF treatment options.

Idiopathic pulmonary fibrosis (IPF) is a severe, progressive lung disease predominantly affecting older adults, with about 0.91 million diagnosed prevalent cases across the 7MM in 2023 as per DelveInsight analysis. Characterized as a chronic and fatal interstitial lung disease, IPF currently has no therapies capable of halting its progressive decline in lung function. Existing treatments often come with poor tolerance, underscoring the significant unmet need for improved therapies. Clinical trials for IPF are particularly burdensome for patients, often struggling with recruitment and experiencing high dropout rates. Vicore Pharma recognizes this urgency and is pioneering innovative solutions, notably with buloxibutid, an angiotensin II type 2 receptor agonist (ATRAG) aimed at stabilizing and improving lung function in IPF patients. Vicore Pharma is committed to addressing patient needs and priorities to make trial participation more appealing and convenient.

At the 2024 American Thoracic Society (ATS) International Conference, Vicore Pharma is set to present multiple findings showcasing their innovative work with angiotensin II type 2 receptor agonists (ATRAGs) on 19th and 20th May 2024. Among the highlights will be an oral late-breaking presentation detailing the final results from the Phase IIa AIR trial of buloxibutid in patients with IPF. Additionally, Vicore will present preclinical and translational data demonstrating the potency of buloxibutid’s upstream mechanism of action and outline the design for the upcoming Phase IIb ASPIRE trial. Vicore will also feature a poster presentation at the ATS Respiratory Innovation Summit, further emphasizing their contributions to respiratory disease research.

During the Phase IIa AIR trial, buloxibutid, administered as a single-arm study, employed high-resolution computerized tomography (HRCT) and spirometry, adhering to ATS protocols to assess forced vital capacity (FVC). Interim results from this trial indicated that buloxibutid stabilized and improved lung function over 36 weeks in IPF patients. These promising interim outcomes are anticipated to be confirmed in the final presentation of the 36-week treatment data at the ATS 2024 conference, offering hope for the future of IPF treatment. Furthermore, non-clinical and translational studies suggest buloxibutid’s efficacy in inhibiting TGFβ1 expression, mesenchymal cell inhibition, and upregulation of surfactants, underscoring its potential as a transformative therapy for IPF.

IPF patients need access to new, improved treatments, which requires scientifically rigorous, holistic, and patient-centric trials. Recognizing the challenges faced by IPF patients in participating in clinical trials, Vicore Pharma has designed the ASPIRE trial with patient input from an advisory panel. This panel comprises six patient representatives (predominantly male) and two female caregiver representatives. The ASPIRE trial aims to address these challenges through the integration of patient and caregiver support strategies and patient empowerment, guided by three main categories: patient first, patient feedback, and promises fulfilled - the 3 PFs in its design, conduct, and reporting. Feedback from patients and caregivers has led to enhancements in trial design, including partially decentralized trial visits, flexible schedules, and the elimination of non-essential procedures, making participation more patient-friendly.

Vicore Pharma is optimistic about buloxibutid’s potential as a novel IPF treatment, moving into the Phase IIb ASPIRE trial to solidify its efficacy and safety. The company’s dedication to holistic patient care, coupled with its exploration of ATRAGs’ therapeutic benefits, signifies a significant milestone in respiratory disease research. By prioritizing patient-centric trial designs and incorporating insights from patient feedback, Vicore Pharma is poised to make a meaningful impact on the lives of those affected by IPF, addressing unmet needs and offering hope for improved treatments.

 

Moreover, C21, Vicore Pharma’s buloxibutid, has demonstrated promising interim trial results in reducing lung scarring and halting IPF progression, with outcomes to be presented at ATS 2024. The consistent long-term stability and improvement in FVC, even with a doubled patient cohort, encourage C21’s future clinical progress. These advancements are crucial in promptly offering effective treatment options for patients with idiopathic pulmonary fibrosis (IPF), aligning with the forecasted expansion of the IPF market from the estimated 2023 market (nearly USD 3,300 million) as projected by DelveInsight analysts in the Idiopathic pulmonary fibrosis (IPF) Market Forecast Report.