OM Pharma successfully submitted an IND application to the FDA

OM Pharma announces that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a phase IIb study of OM-85 in the United States in recurrent wheezing episodes in children aged 6 months to 5 years with recurrent wheezing. OM Pharma announced today that the U.S. Food and Drug Administration (FDA) has cleared its IND application for the phase IIb clinical study, a randomised placebo-controlled, double-blind, multicenter study to assess the efficacy and safety of OM-85 versus placebo given on top of routine treatment in children aged from 6 months to 5 years with recurrent wheezing episodes randomised. OM-85, an extract of different bacterial species, is already marketed in 64 countries under the trademark Broncho-Vaxom® for the prevention of recurrent respiratory tract infections. It has not yet been authorised for commercialisation in the United States. Wheezing is a high-pitched whistling sound made while breathing, often associated with difficulty in breathing. Recurrent wheezing episodes are common in the early years of life; one in three children has at least one episode of acute wheezing before the age of three, with a prevalence of 50% at the age of 6 years1,2, and in the United States they are among the leading causes of hospital admission3. “We are extremely pleased with the FDA’s acceptance of the initiation of our OM-85 Phase IIb trial in preschool children with wheezing. This is an important milestone for OM Pharma towards addressing this high unmet need in paediatric population”, said Dr Mathias Knecht, Chief Medical Officer at OM Pharma. Josef Troxler, CEO of OM Pharma, commented: “This is an important step in the company's ambition to expand its global presence, particularly in the United States, and to continue to develop as a global biopharmaceutical company, addressing the unmet needs of a growing number of patients”. This successful submission further underscores OM Pharma's ability to become a leading global biopharmaceutical company focused on improving the lives of patients by building on its unique heritage in bacterial lysates.   1. Martinez FD, Wright AL, Taussing LM, Holberg CJ, Haloen M, Morgan WJ. Asthma and wheezing in the first six years of life. N Engl J Med 1995;332:133-8. 2. Bisgaard H, Szefler S. Prevalence of asthma-like symptoms in young children. Pediatr Pulmonol 2007;42(8):723-8. 3. Mansbach JM, Camargo CA, Jr. Respiratory viruses in bronchiolitis and their link to recurrent wheezing and asthma. Clin Lab Med 2009;29(4):741-55.

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