OM Pharma Presents Preliminary REACH Study Findings Demonstrating Real-World Benefits of Broncho-Vaxom® in Preventing Recurrent Respiratory Tract Infections
OM Pharma has announced the presentation of preliminary results from its landmark REACH study at the European Academy of Allergy and Clinical Immunology (EAACI) Congress, providing new real-world evidence supporting the effectiveness of Broncho-Vaxom® in reducing recurrent respiratory tract infections (RTIs) and associated healthcare utilization. The study represents the first and largest multinational real-world evidence investigation conducted to date assessing the impact of Broncho-Vaxom® in routine clinical practice among patients experiencing repeated respiratory infections.
The findings offer important insights into how the therapy performs outside the controlled environment of randomized clinical trials and demonstrate its potential to reduce infection recurrence across a broad and diverse patient population. According to OM Pharma, the results reinforce existing clinical evidence and provide physicians with additional confidence in using Broncho-Vaxom® as a preventive strategy for patients affected by recurrent respiratory infections.
Addressing a Widespread Healthcare Challenge
Respiratory tract infections remain among the most common reasons for healthcare visits worldwide. While many infections resolve without long-term complications, a significant number of patients experience recurrent episodes that can severely affect daily life and place a substantial burden on healthcare systems.
Children, older adults, and individuals with underlying health conditions are particularly vulnerable to repeated infections. These recurring illnesses often result in repeated physician consultations, emergency department visits, missed school days, lost productivity at work, and increased healthcare expenditures.
The challenge extends beyond the direct impact on patients. Frequent respiratory infections contribute significantly to antibiotic prescribing, often leading to repeated courses of treatment. This trend has become a growing concern among healthcare professionals and public health authorities because excessive antibiotic use is recognized as a major driver of antimicrobial resistance, one of the most pressing global health threats today.
Against this backdrop, preventive strategies capable of reducing infection recurrence without relying on antibiotics have become increasingly important.
The Largest Real-World Evidence Study of Its Kind
The REACH study was designed to evaluate the effectiveness of Broncho-Vaxom® under real-world clinical conditions rather than within the highly controlled setting of traditional clinical trials.
Real-world evidence studies are increasingly valued because they provide insights into how therapies perform across broader patient populations, including individuals with varying ages, medical histories, and coexisting conditions that may not always be represented in randomized studies.
The preliminary analysis included data from 15,794 patients across China, Italy, and Belgium. Participants ranged from pediatric patients older than one year of age to adolescents, adults, and elderly individuals, making the study one of the most comprehensive evaluations of Broncho-Vaxom® conducted to date.
Researchers assessed outcomes at both 12 and 24 months following treatment initiation and compared them with the 12-month period before patients began therapy.
This approach enabled investigators to evaluate whether treatment with Broncho-Vaxom® was associated with meaningful changes in infection frequency and healthcare resource utilization over time.
Significant Reduction in Respiratory Infection Recurrence
The preliminary findings suggest that Broncho-Vaxom® may play an important role in reducing recurrent respiratory tract infections in everyday clinical practice.
According to the analysis, patients treated with Broncho-Vaxom® experienced fewer respiratory infections requiring medical attention during the follow-up period compared with the year preceding treatment initiation.
The reductions were observed across multiple age groups and among patients with various comorbidities, highlighting the broad applicability of the therapy in real-world settings.
These findings are particularly significant because recurrent respiratory infections often create a cycle of repeated illness, healthcare visits, and ongoing treatment that can be difficult to break. By reducing the frequency of medically attended infections, Broncho-Vaxom® may help alleviate both individual patient burden and broader healthcare system pressures.
The results also suggest that the benefits extend beyond infection prevention alone, potentially reducing the need for repeated physician consultations and other healthcare interventions associated with recurrent respiratory illness.
Strengthening Confidence in Existing Clinical Evidence
Anna Thomas, Chief Scientific Officer at OM Pharma, emphasized the importance of the findings in demonstrating the real-world effectiveness of Broncho-Vaxom®.
She noted that recurrent respiratory infections represent a significant medical challenge that can have substantial consequences for patients, families, and healthcare systems. According to Thomas, the REACH study demonstrates that Broncho-Vaxom® can significantly reduce infections requiring medical visits across a wide range of patient populations and underlying health conditions.
She further highlighted that the scale of the study and the consistency of the findings provide strong support for existing clinical evidence accumulated over years of research. The new real-world data, she explained, should give healthcare professionals greater confidence in their ability to address recurrent respiratory infections through preventive treatment approaches rather than relying solely on reactive management after infections occur.
The study therefore serves as an important bridge between controlled clinical trial outcomes and everyday clinical practice, showing that the benefits observed in research settings can translate into meaningful results in routine patient care.
Impact on Patients and Families
For patients experiencing recurrent respiratory infections, the consequences often extend far beyond temporary physical symptoms.
Repeated infections can interfere with school attendance, workplace productivity, social engagement, and overall quality of life. Children may miss critical educational opportunities, while adults may face disruptions to employment and family responsibilities.
Chronic cycles of illness can also create emotional stress and anxiety for both patients and caregivers, particularly when infections occur frequently or lead to complications.
Vildana Mujkić, Board Member and Eastern European Alliance Leader of the Global Allergy & Airways Patient Platform (GAAPP), emphasized the patient-centered significance of the study.
She explained that for individuals living with recurrent respiratory infections, prevention is not simply a clinical goal but a key factor in reducing overall disease burden. The ability to lower infection rates can enable patients to lead healthier, more active lives while reducing the disruptions associated with repeated illness.
According to Mujkić, research such as the REACH study contributes to a more informed and patient-focused approach to care by providing evidence that supports preventive treatment strategies capable of improving long-term outcomes.
Potential Role in Reducing Antibiotic Use
One of the most important implications of the REACH findings may be their relevance to ongoing efforts to combat antimicrobial resistance.
Respiratory tract infections are among the leading reasons antibiotics are prescribed globally. Although many respiratory infections are viral and may not require antibiotic treatment, recurrent episodes often result in repeated prescribing patterns.
Over time, excessive antibiotic use contributes to the development and spread of antimicrobial resistance, making infections more difficult to treat and increasing healthcare costs and mortality risks.
By helping prevent recurrent respiratory infections, Broncho-Vaxom® may indirectly reduce the need for repeated antibiotic courses. This aligns with broader public health initiatives aimed at preserving the effectiveness of existing antibiotics and promoting responsible antimicrobial stewardship.
Healthcare systems worldwide are increasingly prioritizing preventive interventions that can reduce reliance on antibiotics while improving patient outcomes, making the findings from the REACH study particularly timely.
Supporting the EAACI 2026 Vision
The preliminary results were presented within the context of the EAACI 2026 Congress theme, “Vision Zero: A Future Free from Allergy and Asthma Burden.”
This theme reflects a broader ambition within the respiratory health community to reduce the impact of chronic airway diseases and improve long-term respiratory outcomes.
Respiratory infections are widely recognized as one of the most common triggers of asthma exacerbations and chronic airway inflammation. Frequent infections can worsen respiratory symptoms, contribute to disease progression, and increase healthcare utilization among individuals with asthma and other chronic respiratory conditions.
The REACH findings suggest that effective prevention of recurrent respiratory infections may play an important role in supporting this broader vision. By reducing infection frequency, preventive strategies such as Broncho-Vaxom® could potentially help decrease respiratory complications and lessen the burden of chronic airway diseases.
As healthcare providers increasingly seek integrated approaches to respiratory disease management, interventions that target infection prevention may become an important component of comprehensive care strategies.
While the preliminary results provide encouraging evidence regarding the effectiveness of Broncho-Vaxom® in routine clinical practice, further analyses from the REACH study are still underway.
OM Pharma reported that the study’s second primary endpoint is currently being evaluated. This analysis will examine outcomes among matched untreated patient cohorts within the real-world data sets, providing a more detailed comparison of treatment effects.
The results of this additional analysis are expected to be released later this year and may offer further insights into the magnitude and consistency of Broncho-Vaxom®’s clinical benefits.
Expanding the Evidence Base for Preventive Respiratory Care
The REACH study represents an important milestone in the ongoing effort to better understand how preventive therapies can address recurrent respiratory infections in diverse patient populations.
By analyzing outcomes from nearly 16,000 patients across multiple countries and age groups, the study provides one of the most comprehensive assessments of Broncho-Vaxom® conducted in real-world practice. The preliminary findings indicate meaningful reductions in infection recurrence and healthcare utilization, reinforcing the therapy’s potential role in preventive respiratory care.
As concerns about recurrent respiratory infections, healthcare resource strain, and antimicrobial resistance continue to grow worldwide, the development and validation of effective non-antibiotic preventive strategies remain a priority for clinicians and public health leaders alike.
The full results of the REACH program will be closely watched by the medical community as researchers continue to explore new approaches to reducing the burden of respiratory disease and improving outcomes for patients across all stages of life.
About recurrent RTIs
Recurrent RTIs are a major global health burden.4,9 Beyond their clinical impact, respiratory tract infections generate significant healthcare and societal costs, largely driven by frequent medical visits and lost productivity.5,10-12 These findings show that Broncho-Vaxom® helps reduce infection frequency and decrease the need for physician visits, supporting its role as a preventive option in routine clinical practice.
About the real-world REACH study
OM Pharma’s REACH (Real-World Evidence study of OM-85 in Adults and Children in CHina, Italy, and Belgium) study is a multi-country, non-interventional cohort study that used secondary data extracted from healthcare databases in two European countries (THIN Belgium and THIN Italy) and China (Inspur).2 This means that the data analysed were not collected specifically for evaluating routine practice or the effectiveness of Broncho-Vaxom®.
Instead, medical records generated during routine care in primary, secondary, or tertiary settings were later extracted and analysed. This is the largest RWE study on this product to date. The preliminary results are consistent with previous clinical studies demonstrating the preventive effects of Broncho-Vaxom®, extending this evidence to broader, real-world populations covering its large indication.
About Broncho-Vaxom® (OM-85)
Broncho-Vaxom® is a therapy derived from selected and inactivated bacterial strains that train and strengthen the immune system to prevent recurrent respiratory infections. OM-85 has been proven to help reduce the incidence and severity of recurrent respiratory tract infections (RTIs) in children and adults and is being currently tested for potential beyond these uses, for example, in chronic conditions such as asthma or wheezing.13
In 2025, over 5 million people were reached with Broncho-Vaxom®.14 It is currently registered in 69 countries worldwide for the prevention of recurrent RTIs in children and adults. Broncho-Vaxom® is also commercialised in other countries under different brand names, including Broncho‑Munal®, Ommunal® and Paxoral®.
About OM Pharma
OM Pharma is pioneering a new standard of care for patients suffering from frequent infections. The company develops innovative bacterial lysate therapies designed to strengthen the immune system. By training the body’s natural defences, these therapies help patients fight infections that keep coming back. Headquartered in Geneva, OM Pharma operates an integrated biotech campus that brings together research and development, manufacturing, and distribution. Drawing on 90 years of expertise, OM Pharma serves patients in more than 100 countries and reaches approximately 16 million people worldwide.
