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# Staphylococcus aureus Phage Product Candidate
## **AP-SA02**
AP-SA02 is a novel biologic product candidate comprising natural lytic phages that target the problematic pathogen, *Staphylococcus aureus*, and offers robust therapeutic attributes, including:
* Potent antimicrobial activity against approximately 95% of *S. aureus c*linical isolates tested, including drug-resistant isolates (MRSA: methicillin-resistant *S. aureus* and VRSA: vancomycin-resistant *S. aureus*);
* Unique mechanism of action offers independent or synergistic benefit with standard of care antibiotics;
* Component phages are stable and retain infectivity after exposure to relevant biological fluids;
* Penetrates pre-existing *S. aureus* biofilms.
Clinical trial material of AP-SA02 is currently manufactured under cGMP at our production facility in California to support the required regulatory filing(s) for clinical studies in the U.S. and ex-U.S.
Armata is committed to developing novel phage therapies that specifically address areas of high need. We have an acute bacterial infection clinical development plan focused on *Staphylococcus aureus* bacteremia, a difficult-to-treat and often life-threatening human infection that can result in high morbidity and mortality and for which bacterial resistance to antibiotics is growing.
The “ is a Phase 1b/2a, randomized, double‐blind, placebo‐controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP‐SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteremia due to *Staphylococcus aureus*. The objectives of this study are to: (i) demonstrate safety and tolerability of multiple different dose levels of AP-SA02; (ii) evaluate optimal dosing through safety, pharmacokinetics and microbial efficacy; and (iii) explore efficacy through evaluation of key meaningful endpoints. The study is being conducted at sites in the United States and also at sites abroad in Australia.
Since dosing the first patient in the  portion of the study on September 26, 2023, we have focused on accelerating enrollment of the diSArm study, evaluating safety with higher intravenous doses, which is possible due to the high purity of our phage product candidates. The high purity of our phages has allowed us to dose escalate to 5E10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed. One subset, comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood providing early evidence of in vivo phage amplification and resultant release of phage progeny. In November 2024, we  the completion of enrollment of the Phase 1b/2a diSArm study. We anticipate topline data from the diSArm study in the first quarter of 2025 where we can explore the two aforementioned subsets in an unblinded manner. We are committed to developing a pivotal *S. aureus* bacteremia trial in 2025 to evaluate the intravenous phage product candidate, AP-SA02, as an adjunct to standard of care broad-spectrum antibiotics and/or potentially as an alternative to broad-spectrum antibiotics, which would decrease the utilization of broad-spectrum antibiotics and their detrimental impact on the healthy human microbiome. We anticipate findings from the Phase 1b/2a study will provide the basis for constructing a robust trial strategy for registration which can be the basis for an End-of-Phase-2 meeting with the FDA that enables us to obtain agreement on a path to approval in 2025.
The Phase 1b/2a study is partially funded by a $21.6 million  administered by the U.S Department of Defense through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.
**Target Market and Medical Need**
Bacteremia is a bacterial infection of the bloodstream. A common diagnosis, the Centers for Disease Control and Prevention (CDC) estimates that up to 1.7 million people in the U.S. develop bacteremia each year. *S. aureus* is the most commonly identified pathogen in both hospital- and community-acquired blood stream infections. Annually in the U.S. there are approximately 200,000 hospitalizations for *S. aureus* bacteremia (SAB). Despite conventional antibiotics, mortality in SAB results in death of up to 40% of all cases and 57% of patients over the age of 85. Patients with comorbidities such as alcoholism, malignancy, diabetes, end-stage renal disease requiring hemodialysis, and immunosuppression are at even higher risk for death when SAB develops. Age-adjusted mortality assessments show that SAB mortality is higher than that of AIDS, tuberculosis, or viral hepatitis, and comparable to mortality rates for breast or prostate cancer. Outcomes are even poorer for SAB due to methicillin-resistant *S. aureus* (MRSA), classified as a serious threat to global health by the CDC and a high priority threat by the World Health Organization, with higher rates of complications and increased mortality as compared to methicillin-susceptible *S. aureus* (MSSA). Average hospital costs to patients with nosocomial SAB ranges between $40,000 (MSSA) and $114,000 (MRSA). Treatment failures are common in SAB, with highest rates due to MRSA. These failures can be attributed in part to poor penetration of some tissues by antibiotics, slow onset of bactericidal effects, emerging resistance patterns, and biofilm formation. While biofilms can render traditional antibiotics ineffective, phages may have the ability to penetrate the biofilm allowing rapid and efficient infection of the host and amplification at the site of infection. Until the recent FDA approval of Zevtera (intravenously administered cephalosporin antibiotic), daptomycin (approved in 2005; based on clinical cure rates of <50%) and vancomycin were the only two antibiotics with label indications in the U.S. for the treatment of SAB, and the emergence of drug-resistant *S. aureus* isolates, including to these two standard of care drugs, represents a major threat in terms of increasing morbidity, mortality and health care utilization.
**Additional Clinical Indications for AP-SA02**
Improved patient outcomes are needed for other *Staphylococcal* infections, in settings such as prosthetic joint infections and wound infections, for which antimicrobial resistance is a growing concern. We believe AP-SA02 could also have a meaningful impact in these indications, particularly infections caused by methicillin-resistant *S. aureus* (MRSA). In August, 2022, the U.S. FDA cleared Armata’s  for AP-SA02 in a second indication, prosthetic joint infection (PJI).
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# Other Programs
## Synthetic Phage Program
Our proprietary phage engineering platform serves to enhance the clinical and commercial prospects of phage therapy. These attributes include expanded host range, improved potency which is a fundamental drug property that can translate into improved clinical efficacy, and importantly, biofilm disruption, which is a critical aspect of serious infections that needs to be addressed. Microbiologists at Armata evaluate the suitability of natural phages for engineering using our proprietary .
## Discovery Research
In addition to our more advanced pipeline programs targeting *Pseudomonas* and *Staphylococcus*, Armata has phage discovery efforts to target other major bacterial pathogens of infectious disease, and preventable disease of the microbiome.
We see bacteriophages as a potentially safer and effective alternative to antibiotics and an essential response to the growing bacterial resistance to current classes of antibiotics. Bacteriophages or “phages” have a powerful and highly differentiated mechanism of action that enables binding to and killing of specific targeted bacteria while uniquely preserving the normal human microbiome or “healthy bacteria”. This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as *Clostridium difficile*.
The developing science of the microbiome highlights the potential to impact a broad array of human disease, from oral healthcare to systemic diseases, such as autoimmunity, and immuno-oncology. The complexity of the developing science demands a broad effort in clarifying microbial-host interactions, designing intervention strategies, and crafting a viable clinical path. Armata’s strategy is to seek partners that share a long-term commitment to develop meaningful microbiome therapies utilizing the exquisite specificity offered by natural and/or synthetic bacteriophages.
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