Business Update
Positive Interim Results for Single-Patient Expanded Access Program
On January 3, 2018, AmpliPhi Biosciences Corp. (APHB) announced positive interim results from the company’s single-patient expanded access program. A total of seven patients with serious or life-threatening infections, which were not responding to antibiotic therapy, were treated with AB-SA01 (n=4) or AB-PA01 (n=3). Six out of the seven patients (86%) achieved “treatment success”, which was defined as complete resolution or significant improvement of baseline signs and symptoms.
AmpliPhi is developing bacteriophage therapeutics for the treatment of bacterial infections. Bacteriophages are viruses that infect, replicate in, and kill bacterial cells while not harming eukaryotic cells. This exclusivity is vital to their use in combating infectious diseases, and their unique mechanism of action compared to traditional antibiotics means they can be used in place of or in conjunction with those therapies. AB-SA01 is being developed for the treatment of Staphylococcus aureus infections, including methicillin-resistant S. aureus (MRSA) infections. It contains three phage constituents that target greater than 96.7% of S. aureus isolates from a global diversity panel. AB-PA01 is being developed for the treatment of Pseudomonas aeruginosa infections. It contains four phage constituents that target approximately 80% of P. aeruginosa strains, including multi-drug resistant isolates.
The company’s strategy is to use single patient expanded access protocols (Emergency IND in the U.S. and Special Access Scheme in Australia) to derive real-world data using AB-SA01 and AB-PA01 in patients suffering from severe, multidrug-resistant (MDR) infections. The following schematic shows the treatment schedule for the expanded access protocol. In order for a patient to qualify, they would need to have a serious or life-threatening infection that was not responding to antibiotics and that was also susceptible to either AB-SA01 or AB-PA01. Testing to confirm susceptibility to AB-SA01 or AB-PA01 can be performed in approximately 48 hours.
