Qureight and Avalyn Launch Strategic Partnership in Progressive Pulmonary Fibrosis
Qureight Ltd, the Core Imaging Laboratory developing deep-learning image analytics, and Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on developing inhaled therapies to treat life-threatening pulmonary diseases, today announce the initiation of a strategic partnership in progressive pulmonary fibrosis, commencing with the ongoing MIST study, a Phase 2b clinical trial evaluating the safety and efficacy of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF).
New partnership marks the first time deep-learning imaging technologies have been used in a PPF clinical study.
Qureight technology selected to assess a MIST study clinical outcome measure
Qureight’s Core Imaging Platform technology will be extended across multiple Avalyn studies
Progressive pulmonary fibrosis (PPF) is characterized by progressive scarring of lung tissue, leading to a progressive decline in lung function, worsening symptoms, and diminished quality of life with a poor prognosis. There is currently no cure for PPF. Current oral antifibrotic standard-of-care therapies can slow disease progression but are associated with significant side effects, which restrict their duration of use and dosing. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in PPF. Avalyn’s inhaled approach is designed to reduce systemic exposure and improve efficacy by delivering medication to the site of the disease. The Qureight platform, built using real-world and clinical study data, links imaging more closely to clinical endpoints. This is especially important for PPF where diagnosis, monitoring and clinical development pathways can be complex and data fragmented. Avalyn and Qureight expect to release additional promising data analyses using Qureight technology at future medical conferences.
Howard M. Lazarus, MD, FCCP, CMO of Avalyn, said, “Given the complex nature of PPF, we've made it a priority to leverage cutting-edge technology to measure treatment response in our ongoing MIST study. This collaboration with Qureight will allow us to measure changes in fibrosis volume more sensitively while also enabling us to quantify changes across multiple compartments of the lung that we believe are also linked with disease progression.”
Dr Muhunthan Thillai, CEO of Qureight, said, “As a lung disease doctor, I’m really excited about the future of inhaled therapies in treating progressive fibrotic lung diseases. Partnering with Avalyn on the MIST study is an important opportunity to see our Core Imaging Platform used to support PPF patients for the first time, to enable optimal enrolment of patients in addition to quantifying their response to treatment with AP01. Our mission is to redefine precision medicine through AI in clinical trials, and this aligns perfectly with that of Avalyn in delivering effective and tolerable treatments for pulmonary fibrosis patients.”
About Qureight
Founded in 2018 and headquartered in Cambridge, UK, Qureight is a Core Imaging Laboratory; a rapidly-scaling techbio startup operating on a global scale. The cloud-based, vendor-agnostic platform is GDPR, HIPPA and NHS Digital compliant. The platform has ISO13485 and ISO27001 accreditation to interrogate clinical trial data. The team is led by co-founder & CEO Dr Muhunthan Thillai, a consultant pulmonologist at Royal Papworth Hospital in Cambridge who trained in lung fibrosis.
About Avalyn
Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. Avalyn has a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.
About PPF
There are more than 200 types of ILD, which are characterized by varied amounts of inflammation, scarring, or both, that damage the lung’s ability to absorb oxygen. Idiopathic Pulmonary Fibrosis (IPF) is the most well-known form of ILD, affecting 100,000 patients in the US. Progressive Pulmonary Fibrosis (PPF) is a larger and even more poorly served segment of the ILD market, affecting up to 200,000 patients in the US. IPF & PPF are associated with the unregulated production of fibrotic, scar-like tissue that builds up in the scaffolding of the lungs, challenging the ability to breathe and reducing the absorption of inhaled oxygen into the blood. In addition, fibrotic lung tissue has less flexibility than healthy lung tissue, adding to the feeling of being short of breath, which is common in people suffering from pulmonary fibrosis (PF).