Multiple Case Reports Presented for Patients Treated with AB-SA01 and AB-PA01
On June 7, 2018, AmpliPhi Biosciences Corp. (NYSE:APHB) reported that multiple case reports on patients treated with the company’s lead bacteriophage development products, AB-SA01 and AB-PA01, were presented at the American Society of Microbiology (ASM) Annual Meeting and the 41st European Cystic Fibrosis Conference. Topline results from these cases had previously been announced by AmpliPhi with the presentations providing additional details.
At ASM, a presentation described four cases of severe Staphylococcus aureus infection treated with AB-SA01. Three of the cases involved patients with endovascular infection and one case of severe vertebral osteomyelitis with epidural abscess. For all the patients, medical and surgical therapy options had been exhausted. Patients were treated with 3×109 plaque-forming units of AB-SA01 intravenously twice-daily for two weeks in combination with the best antibiotic therapy available. The bacteriophage therapy was well tolerated in all patients with no reports of serious adverse events. Three of the patients had elimination of their infection while the fourth patient only received two days of bacteriophage treatment after suffering from uncontrolled septic shock and valve necrosis and passed away during surgery due to dehiscence of newly implanted valves. This is summarized in the following chart.
At the European Cystic Fibrosis Conference, a presentation described the case of a 26-year-old cystic fibrosis patient who was unable to get a double lung transplant due to recurrent bouts of pneumonia caused by multidrug resistant Pseudomonas aeruginosa infection. The patient had received multiple courses of antibiotics, including colistin, but due to renal failure the colistin had to be stopped. AB-PA01 was administered every six hours for eight weeks intravenously as an adjunctive treatment to systemic antibiotics. There were no bacteriophage-related adverse events reported. The following chart shows the patient’s baseline symptoms before bacteriophage treatment began and at the end of treatment. The infection resolved by Day 7 and there was no recurrent pneumonia or CF exacerbations during treatment or 90 days after the end of bacteriophage therapy.
The data presented on these cases provide additional details regarding the results that were previously announced by AmpliPhi on the use of AB-SA01 and AB-PA01 in the expanded access setting. We believe the data that AmpliPhi has compiled thus far has been very encouraging. We continue to believe that the company will have compiled sufficient data by mid-2018 to approach the FDA about a registration pathway for AB-SA01 and AB-PA01 with a Phase 2 trial possibly starting in the fourth quarter of 2018. Our current valuation is $4.00 per share. However, we believe there is likely to be significant upside to our model once we learn more about what indications the company will be targeting later in 2018 for Phase 2 studies, at which time we may also get a better sense of timelines for approval.
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