Arpida presents positive trial oral iclaprim data
clinical trial with oral iclaprim in a capsule formulation. This
broad-spectrum antibiotic targets infections requiring hospital
treatment, including those caused by methicillin-resistant
Staphylococcus aureus (MRSA).
Oral iclaprim could offer significant benefits as a switch from intravenous to oral administration, enabling patients to be discharged from hospitals earlier by allowing them to continue and complete their treatment at home.
This switch potentially lowers healthcare costs while at the same time reducing the probability of the patient contracting new infections.
The primary objective of this study was to assess the bioavailability of iclaprim from an oral capsule formulation as compared to the intravenous formulation.
In this Phase I trial, eight healthy volunteers received one dose of oral iclaprim and one dose of intravenous iclaprim for comparative purposes.
The results show an oral bioavailability of iclaprim from the capsule of around 40 per cent and confirm that oral administration of iclaprim can easily achieve blood levels comparable with those of therapeutic doses of intravenous iclaprim.
These results confirm those of a study investigating the solution formulation of oral iclaprim.
"These studies indicate that oral administration of iclaprim can achieve an exposure comparable to the dose that is used in the on-going Phase III trial with intravenous iclaprim," said Dr Khalid Islam, president and CEO of Arpida.
"We strongly believe that the availability of an oral formulation will be one of the key differentiating features of iclaprim over virtually all of the antibiotics for the treatment of bacterial infections including MRSA," he added.
Arpida has now successfully completed three Phase I trials with oral formulations of iclaprim: an ADME study (absorption, distribution, metabolism and excretion) with radiolabelled iclaprim, a bioavailability study with a solution and one with a capsule formulation.
Additional Phase I trials are planned during the year and are expected to provide the foundation for later-stage clinical trials.
Meanwhile, the intravenous formulation of iclaprim is currently in Phase III trials for the treatment of complicated skin and skin structure infections (cSSSI).
Such is the extent of the situation, the US Food and Drug Administration (FDA) has granted fast track status to intravenous iclaprim for the treatment of cSSSI.
MRSA is a type of bacteria that is resistant to almost all antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin and amoxicillin. S. aureus infections, including MRSA, occur most frequently among persons in hospitals and healthcare facilities (such as nursing homes and dialysis centres) who have weakened immune systems.
It has been estimated that antibiotic resistance costs US society between $4 billion and $5 billion (€3.4 billion - €4.2 billion) annually.
According to the CDC, antibiotic resistance has become so widespread that many significant bacterial infections in the world are becoming resistant to commonly used antibiotics.
