Fraunhofer Institute for Toxicology and Experimental MedicineOM Pharma and Fraunhofer ITEM announce initiation of early-phase clinical trial
First participant dosed in Phase Ia/Ib clinical trial evaluating safety and tolerability of OM-85-Intranasal (IN) in healthy volunteers and patients with mild allergic asthma
- Initiation of Phase Ia/Ib1 with the first human administration of the intranasal form of OM-85, a bacterial lysate and immune system modulator, already approved in oral form for the prevention of recurrent respiratory tract infections.
- Trial aims to deepen and understanding of OM-85-Intranasal (IN) and explore its potential impact on asthma management when administered as a nasal spray.
(Geneva) OM Pharma, a global Geneva-based biotech and leader in bacterial lysate products, in collaboration with Fraunhofer Institute for Toxicology and Experimental Medicine ITEM announce the dosing of the first participant in a Phase Ia/Ib clinical trial evaluating the safety and tolerability of OM-85-Intranasal (IN) in 27 healthy volunteers during Phase Ia and 14 patients with mild asthma during Phase Ib.
Manufactured at the OM Pharma site in Geneva using chemical lysis, OM-85 is a bacterial lysate derived from 21 heat-inactivated strains of respiratory pathogenic bacteria. OM-85 is already approved as an oral form for the prevention of recurrent respiratory tract infections in children and adults in many countries worldwide. This milestone marks the start of clinical development of a new intranasal form of OM-85, administered as a nasal spray, targeting patients with mild asthma.
This innovative route of administration for OM-85 aims to provide a rapid and targeted delivery, potentially enhancing OM-85’s therapeutic benefits for patients with asthma. The nasal spray directly delivers the product onto nasal mucosa providing topical activity.
"We are delighted to initiate this important clinical trial in collaboration with Fraunhofer ITEM" said Dr. Lorenz Lehr, Head of Clinical and Preclinical Development at OM Pharma. "OM-85 Intranasal administration has shown promising results in several preclinical allergic asthma models2, and we are excited to evaluate its first administration not only in healthy volunteers but also in patients with mild asthma. This trial represents a significant step forward in our commitment to developing innovative therapies for patients with asthma".
"We are proud to join OM Pharma on this exciting journey, taking OM-85-Intranasal from preclinical stages through to human application" said Professor Jens Hohlfeld, Division Director of Clinical Research at Fraunhofer ITEM. "This project fits perfectly with our translational research mission of developing new medicines to improve patient health".
OM Pharma and Fraunhofer ITEM anticipate that the results of this Phase I trial will provide valuable insights into the safety and tolerability of OM-85-IN, with first signs of efficacy, paving the way for further clinical development and future registrations.
1https://clinicaltrials.gov/study/NCT06486662
2Pivniouk V, et al. Airway administration of OM-85, a bacterial lysate, blocks experimental asthma by targeting dendritic cells and the epithelium/IL-33/ILC2 axis. J Allergy Clin Immunol. 2022 Mar;149(3):943-956. doi: 10.1016/j.jaci.2021.09.013.
Further information
Early-phase and proof-of-concept clinical trials
Brief information about our project partner
OM Pharma is transforming immune health, addressing some of the most urgent individual and global health challenges by leveraging expertise in bacterial lysates. Currently active in the prevention of respiratory and urinary tract infections, OM Pharma also invests in new indications and new formulations for bacterial lysates. Beyond a focus on bacteria-based products, OM Pharma also markets small molecules for the treatment of vascular diseases globally. Headquartered in Geneva, OM Pharma products are available in more than 100 countries through a network of trusted partners.
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