US-based Sigma-Tau Pharmaceuticals (Sigma-Tau) has dosed the first patient in its phase 1/2 multi-centre, double-blind, randomised, placebo-controlled clinical trial for STP206, for the prevention of necrotising enterocolitis (NEC) in very low birth weight premature infants.
STP206 is a live biotherapeutic currently being developed in the US, under an FDA investigational new drug application (IND).
NEC is a serious medical condition of the gastrointestinal tract in premature infants and it mostly affects infants weighing under 1,500g.
It is reported that the disease would occur in about 10% of very low birth weight (=1500g) infants and about one in every 2,000-4,000 births.
Currently, there is no FDA approved treatment for the disease, resulting in an urgent, unmet medical need.
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The company said that NEC is characterised by signs of abdominal distension, intra-abdominal inflammation and radiologic presence of pneumatosis intestinalis (gas in the bowel wall) and/or portal venous air or free air indicating perforation of the bowel, which in the most severe cases can be life threatening.
Sigma-Tau CEO Dave Lemus said: "Sigma-Tau remains committed to serving those affected by rare diseases.
"Dosing of the first patient in our phase 1/2 trial for STP206 represents an important milestone in the continued development of this novel therapy for the prevention of NEC in premature infants with a very low birth weight, a life threatening disease with no currently FDA approved treatment.
"Additionally, we are pleased that this programme has played a central role in helping advance the further development of live biotherapeutics, and in that vein, aspire to become the first FDA approved live biotherapeutic on the market."
A live biotherapeutic is a biological product that includes live microorganisms, such as bacteria or yeast, that are naturally occurring, recombinant or clonally selected.
The products are applicable to the prevention, treatment or cure of a disease or condition of human beings, and are not an immunogen-specific vaccine.
Image: Campylobacter, a causative agent of acute enterocolitis. Photo: courtesy of PDH.
