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.
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.