'We Have The Potential To Address At Least $1 Bn Of The SSI Market'

Recently, CHD Bioscience signed a global licensing agreement with Dr Reddy's Laboratories for developing and commercialising its phase III candidate DFA-02. Michael Handley, CEO, CHD Bioscience, talks about the plans for clinical trials of the molecule, with Usha Sharma.

- Usha Sharma

What is the progress on DFA-02 clinical studies? Tell us more about its prospects.

DFA-02 is positioned to enter into a phase III clinical study for mitigation of complex abdominal infections in high risk patient populations. CHD Bioscience is currently in discussions with the FDA on the biostatistical powering and the study design. We will have a Type C meeting in the coming months to determine study design and study size. CHD believes DFA-02 has a place in the acute care setting beyond complex abdominal infections and we will be exploring other indications in cardiovascular surgeries and complex bone fixation surgeries.

When will DFA-02 enter phase III studies? When is it likely to commence?

Initiation of the phase III study is dependent on several factors, the most important being FDA approval of the study design and study size. We anticipate enrolling the first patient in the first half of 2018.