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
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.
Can you elaborate on your strategy to become a leader in prevention and treatment of drug-resistant infections?
We have performed extensive analysis of the antimicrobial landscape and determined that approximately 30 per cent of the population has comorbidities that make it difficult to safely dose these patients with large quantities of systemic antibiotics. To fight resistance, it is important to kill all microbes where they live. Systemics are challenged by this and it leads to increased resistance (can’t kill what you can’t reach). By using targeted therapies, we can safely increase to localised drug concentration where the microbes are while lowering systemic drug exposure.
Furthermore, as our understanding of the human microbiome has improved, we now understand that most of our intrinsic microbiome has a supportive effect in the maintenance of a healthy immune system. By using systemic antibiotics, you run the risk of wiping out all the beneficial bacteria, potentially exposing the patient to a weakened immune system and re-population of pathogenic microbes like C. diff that can cause prolonged illness and even death. As a result, we have made the decision to focus on this subset of the patient population, one on which no other company is currently focussed. Consequently, we are developing a pipeline of products that fit our product target profile (localised targeted delivery, low systemic exposure, high concentrations to destroy even the most drug resistant bacteria).
How big is the surgical site infection market?
By most market estimates, the surgical site infection (SSI) market is the largest of the HAI market. With an estimated 300,000 cases of SSI per year in the US, this would represent a very large market potential for CHD. With our current products in development, we have the potential to address at least $1 billion of that market.
Do you want to increase your focus on hospital business?
CHD is increasing the focus on the acute care side of the business as we feel hospital CEOs are subject to ever increasing pressure to lower costs. One of the easier ways for hospital CEOs to reduce cost is to mitigate or lower the number of HAIs that occur at their facilities as HAIs subject them to reimbursement penalties and additional costs.