OM Pharma to Unveil the Largest Multi-Country Real-World Evidence Study on Broncho‑Vaxom® (OM‑85) for RTI Prevention at EAACI 2026

• REACH study met its first primary endpoint, showing that Broncho‑Vaxom® (OM‑85) was associated with a 28-38% reduction in respiratory tract infection rates at 12 months and 29-41% reduction at 24 months, comparing post-treatment versus pre-treatment initiation.¹
• The reduction was observed regardless of the frequency of respiratory tract infections in the previous year (1-3, >3) and across age subgroups (1-5, 6-11, 12-17, 18-64, >64 years).¹
• By reflecting everyday clinical practice and capturing episodes that necessitated a visit to the doctor, these extensive data offer critical new evidence of the therapy’s long-term relevance for patients suffering from recurrent respiratory tract infections.
• Evaluating a vast cohort of more than 15,790 paediatric, adolescent, adult and elderly patients in China, Italy, and Belgium, REACH represents the largest and only multi-country real-world evidence study to date for Broncho-Vaxom^®.^1,2 The study cohort includes patients with different co-morbidities including asthma, COPD, chronic bronchitis, and allergic rhinitis.^1,2
• Professor Giorgio Walter Canonica, Personalized Medicine Center: Asthma and Allergy, Humanitas Research Hospital, and REACH steering committee member, will present the REACH preliminary results at EAACI 2026 on June 14.

GENEVA–(BUSINESS WIRE)–OM Pharma will reveal preliminary results from the REACH study at the European Academy of Allergy and Clinical Immunology (EAACI) Congress. REACH is the first and largest multi-country real-world evidence (RWE) study to date evaluating the impact of Broncho-Vaxom^® in patients with recurrent respiratory tract infections (RTIs).^1,2 The findings offer critical new clinical evidence of the therapy’s effectiveness in everyday clinical practice.

In a real-world cohort of 15,794 paediatric (aged >1 year), adolescent, adult and elderly patients in China, Italy, and Belgium, Broncho-Vaxom^® was associated with reductions in RTI recurrence and healthcare utilisation at 12 and 24 months after treatment initiation, compared with the 12 months prior to starting the therapy.¹

“The REACH real-world evidence study shows that Broncho-Vaxom® can significantly reduce infections requiring medical visits across age groups and co-morbidities,” said Anna Thomas, Chief Scientific Officer at OM Pharma. “Recurrency of respiratory infections is an important medical issue with severe impacts for patients. This extensive evidence in a real world setting strongly reinforces existing clinical data and should give physicians greater confidence that they have the possibility to address RTI recurrence, relieving patient burden.”

Recurrent RTIs impose a profound, dual burden: for patients, they mean persistent illness, missed days of school or work, and a significantly diminished quality of life.^3-5 On a societal level, recurrent RTIs drive a high volume of medical visits, strain healthcare infrastructure, and remain a primary catalyst for antibiotic prescription.^3-6 Antibiotic overprescription is fuelling the global antimicrobial resistance crisis.⁷

Vildana Mujkić, Board Member and Eastern European Alliance Leader, Global Allergy & Airways Patient Platform (GAAPP), stated:

“For individuals living with recurrent respiratory infections, prevention is not just a clinical objective-it is key to reducing their overall disease burden. This study provides valuable real-world evidence demonstrating how preventive strategies can meaningfully lower infection rates. Patients and families need solutions that enable healthier, more active lives, and research like this helps advance more informed, patient-centred care.”

The REACH study findings, which show that Broncho-Vaxom® leads to a reduction in RTI recurrence that required medical visits, directly support the EAACI 2026 theme, “Vision Zero: A Future Free from Allergy and Asthma Burden.” Because respiratory infections are among the most common triggers for asthma exacerbations and chronic airway inflammation, identifying effective, non-antibiotic strategies to address frequent RTIs is a critical step toward helping to achieve “Vision Zero” and lifting the systemic burden of respiratory diseases worldwide.⁸

The second primary endpoint evaluating matched, untreated cohorts within real-world data sets is under analysis and will be released later this year.

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.

References:

1. Canonica GW, Maffert P, Sansone C, Ouillon J, Lehr L, Zheng J, Price D. Effectiveness of Broncho-Vaxom® in Preventing Recurrent Respiratory Tract Infections: Preliminary Findings from REACH, a Multi-Country Real-World Study. Abstract presented at: European Academy of Allergy & Clinical Immunology; June 14, 2026. Abstract reference number: 100283 and Flash Talk (data on file) https://eaaci2026.process.y-congress.com/ScientificProcess/schedule/?sessionGuid=cb0d9ef6-6755-46fe-82eb-9682e4f3d30e&setLng=en
2. European Medicines Agency. REACH study: Real-World Evidence study of OM-85 in Adults and Children in China, Italy, and Belgium | HMA-EMA Catalogues of real-world data sources and studies. Europa.eu. Updated March 20, 2026. Accessed May 18, 2026. https://catalogues.ema.europa.eu/node/4217/administrative-details
3. Schot MJC, Dekker ARJ, van Werkhoven CH, et al. Burden of disease in children with respiratory tract infections in primary care: diary-based cohort study. Family Practice. 2019;36(6):723-729. doi:https://doi.org/10.1093/fampra/cmz024
4. Reed KD. Respiratory Tract Infections. Molecular Medical Microbiology. Published online 2015:1499-1506. doi:https://doi.org/10.1016/b978-0-12-397169-2.00084-6
5. Zhang S, Wahi-Singh P, Wahi-Singh B, Chisholm A, Keeling P, Nair H. Costs of management of acute respiratory infections in older adults: A systematic review and meta-analysis. Journal of Global Health. 2022;12. doi:https://doi.org/10.7189/jogh.12.04096
6. Fleming-Dutra KE, Hersh AL, Shapiro DJ. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016;315(17):1864. doi:https://doi.org/10.1001/jama.2016.4151
7. Antimicrobial Resistance Collaborators. Global Burden of Bacterial Antimicrobial Resistance in 2019: a Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0
8. Busse WW, Lemanske RF Jr, Gern JE. Role of viral respiratory infections in asthma and asthma exacerbations. Lancet. 2010;376(9743):826-834. doi:10.1016/S0140-6736(10)61380-3
9. Jin X, Ren J, Li R, et al. Global burden of upper respiratory infections in 204 countries and territories, from 1990 to 2019. EClinicalMedicine. 2021;37:100986. doi:https://doi.org/10.1016/j.eclinm.2021.100986
10. Zhang S, Akmar LZ, Bailey F, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-S687. doi:10.1093/infdis/jiz683
11. Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003;163(4):487-494. doi:10.1001/archinte.163.4.487
12. Schuez-Havupalo L, Toivonen L, Karppinen S, Kaljonen A, Peltola V. Daycare attendance and respiratory tract infections: a prospective birth cohort study. BMJ Open. 2017;7(9):e014635. Published 2017 Sep 5. doi:10.1136/bmjopen-2016-014635
13. Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Current Opinion in Allergy and Clinical Immunology. 2018;18(3):198-209. doi:https://doi.org/10.1097/ACI.0000000000000433
14. OM Pharma. Data on file.

Contacts

Media Contacts:

Sara Webber

Corporate Communications, OM Pharma

[email protected] I +41 79 511 23 30