RaeSedo Selected to Present New Approach to Asthma Treatment at the 2024 ATS Respiratory Innovation Summit

• RaeSedo's novel approach to asthma treatment is based on the body's own biological mechanisms mediated by surfactant protein-A (SP-A), a naturally occurring protein in the lung that offers multiple benefits for asthma patients, including a reduction in airway inflammation and regulation of key immune cells.
• The company has now successfully aerosolized its lead SP-A-derived peptidomimetic for inhalation, demonstrating the therapy's potential for effective delivery through an inexpensive and convenient to use inhaler device.
• RaeSedo has achieved significant milestones in its development, including preparation for toxicology studies in animals, thanks to collaborations with partners, including Lovelace Biomedical and Genscript.
• With a growing global addressable market for asthma therapeutics expected to reach $37.8 billion by 2032, RaeSedo's innovative approach addresses critical unmet needs in asthma treatment, potentially revolutionizing care for millions worldwide.

TUCSON, Ariz., May 15, 2024 /PRNewswire/ -- RaeSedo, Inc., a biotechnology company developing novel therapeutics for the treatment of asthma and other lung diseases, today announced that it will present its pioneering approach to asthma treatment as a showcase company at the 2024 American Thoracic Society (ATS) Respiratory Innovation Summit (RIS). RIS is an annual event that brings together thought leaders, innovators and decision-makers to discuss the latest advances in respiratory research and technology. RaeSedo Chief Medical Officer and Co-founder Monica Kraft, M.D., will present on May 18, 2024, at 8:30 a.m. PDT.

"As a physician and researcher dedicated to respiratory health, I have witnessed firsthand the challenges faced by my patients with asthma due to the lack of effective treatment options," said Kraft. "While many therapies are approved for the treatment of asthma, many patients remain symptomatic, and many current therapies are associated with short- and long-term side effects. As biologics are reserved for the most severe patients, there is an urgent need for innovative therapies that can provide better outcomes and improve the quality of life for the majority of patients with asthma."

RaeSedo's breakthrough approach to asthma treatment is based on the body's own biological mechanisms mediated by surfactant protein-A (SP-A). SP-A is a large, naturally occurring protein in the lungs that helps remove pathogens, is anti-inflammatory, regulates key immune cells in asthma, reduces mucus production, and reduces airway hyperresponsiveness associated with asthma. This approach has potential application in other lung diseases such as COPD, cystic fibrosis, and treatment of viral infections, such as SARS-CoV-2.

"Our approach using SP-A offers a promising new avenue for asthma treatment," said Kraft. "By leveraging the body's own biological processes, we aim to provide people with asthma with the first therapy that can reduce both inflammation and mucus, improving lung function."

Because SP-A is a large protein, it cannot be delivered to the lungs as a treatment in its naturally occurring state. RaeSedo has identified and developed very small proteins – known as SP-A-derived peptidomimetics – that harness the active regions of SP-A to mimic its biological effects and also have enhanced stability. RaeSedo recently succeeded in aerosolizing C940, its lead SP-A-derived peptidomimetic candidate, demonstrating it can be delivered through an inhaler-type device that is inexpensive to produce and convenient for patients.  

In pre-clinical studies, C940 has been shown to be effective in human airway cells from asthma patients; it was also shown to be effective in pre-clinical animal models of asthma, including:

• Decreasing eosinophilic (60%) and neutrophilic (70%) inflammation
• Decreasing mucus production (70%)
• Decreasing airway hyperresponsiveness (75%)

"As a physician committed to advancing respiratory care, I am excited about the potential of RaeSedo's asthma therapy to revolutionize treatment for patients" said Fernando D. Martinez, M.D., Regents' professor, director, and Swift-McNear Professor of Pediatrics, Asthma & Airway Disease Research Center at The University of Arizona, and RaeSedo scientific advisor. "With millions of individuals, including a significant number of children, suffering with this chronic condition in the United States alone, innovative approaches like this are crucial. RaeSedo's potential therapy could represent a step forward in our quest to provide better, more effective care for those living with asthma."

With approximately 358 million individuals affected globally and 27 million children and adults impacted in the United States alone, asthma remains a pressing health concern. Despite advancements in treatment, the prevalence of this chronic respiratory condition continues to rise. As the market size for asthma therapeutics and management tools is projected to escalate from $25.7 billion in 2023 to an estimated $37.8 billion by 2032, the unmet need for effective asthma care becomes increasingly evident. This growth reflects not only the rising prevalence but also the demand for innovative approaches to address the complex challenges faced by patients and healthcare providers.

RaeSedo has reached important milestones in developing its asthma therapy, thanks to key partnerships. Production is underway with contract manufacturer Genscript, ensuring scalability and quality. Working with Lovelace Biomedical, an aerosol formulation has been developed to optimize concentration and tissue dispersion, enhancing the likelihood of therapeutic effects. Toxicology studies in rats and large animals will begin in the coming months to demonstrate the safety and efficacy of C940.

RaeSedo has filed a robust portfolio of U.S. and international patent applications, expects to file an Investigational New Drug application with the U.S. Food and Drug Administration in the first half of 2025, and is currently seeking investors and development partners.

About RaeSedo, Inc.
RaeSedo, Inc. was founded by a team of women-led physician-scientists that brings together experience in clinical trials, patient care, and translational basic science research. Based on more than a decade of collaborative efforts, and continuous National Institutes of Health funding, RaeSedo has demonstrated that a previously unknown region of activity within surfactant protein A (SP-A), an endogenous lung protein with innate immune properties, is as efficacious as the full-length oligomeric SP-A in reducing airway inflammation associated with asthma. This approach has applications to other lung diseases such as COPD, cystic fibrosis, and treatment of viral infections, such as SARS-CoV-2. Thus, the mission of RaeSedo, Inc. is to generate and optimize new and improved structural peptidomimetics derived from active regions of SP-A in stable, inhaled forms that are as efficacious as endogenous SP-A in reducing inflammation in asthma and other lung diseases.

About ATS Respiratory Innovation Summit
The 2024 ATS Respiratory Innovation Summit, held May 17-18, 2024 in San Diego, CA, will bring together investors and healthcare professionals to witness the latest advancements in pulmonary, critical care and sleep technology. RaeSedo was among 25 companies chosen from a highly competitive applicant pool with innovations in all areas of pulmonary, critical care, or sleep.

SOURCE RaeSedo, Inc.