#USA #Los Angeles #Armata Pharmaceuticals #AP-SA02 #diSArm Study

Armata Pharmaceuticals Makes Strides in Phage Therapy with diSArm Study Results

Armata Pharmaceuticals, Inc. recently announced encouraging topline findings from its Phase 1b/2a clinical trial known as diSArm, which evaluated the effectiveness of AP-SA02, an intravenously administered phage therapy aimed at battling Staphylococcus aureus bacteremia. This pivotal trial focused not only on the safety and tolerability of AP-SA02 but also on its capacity to enhance clinical outcomes in patients facing this challenging bacterial infection.

In the trial, all primary endpoints concerning safety, tolerability, and clinical response in the intent-to-treat (ITT) population were successfully achieved. The AP-SA02 treatment group exhibited significant improvement in clinical outcomes and notably reduced relapse rates compared to the best available antibiotic therapy. Most importantly, the results highlighted that participants treated with AP-SA02 experienced no serious adverse events linked to the drug, demonstrating a favorable safety profile throughout the administration period.

Dr. Deborah Birx, CEO of Armata, emphasized the significance of the findings, stating that this trial represents a substantial leap for both Armata and phage therapy in general. The trial marks a historic achievement, as it provides the first robust evidence from a randomized controlled study showcasing the efficacy of phage therapy against a formidable systemic pathogen that contributes to considerable morbidity and mortality in the United States.

The study, which involved multiple centers, was a double-blind, placebo-controlled trial that randomized participants to receive AP-SA02 in tandem with the best available antibiotic treatment or the placebo alone. The safety evaluation involved a total of 50 subjects, who were closely monitored for any complications arising from the treatment.

AP-SA02 was administered every six hours over a five-day span. Results revealed an impressive responder rate at the Test of Cure assessment (day 12) where 88% of AP-SA02 treated subjects showed clinical improvement, compared to just 58% in the placebo group (p = 0.047). At the follow-up periods, namely the end of treatment and four weeks post-treatment, all subjects treated with AP-SA02 had clinically responded, showcasing an exceptional performance against the practice standards indicated by recent literature, where non-response rates approached 25% for standard treatments.

Interestingly, the phage therapy demonstrated efficacy regardless of the methicillin resistance profile of S. aureus strains—both methicillin-resistant and -sensitive strains were eligible for inclusion. Particularly encouraging was the complete clearance of infections in all MRSA patients treated with AP-SA02, without experiencing any relapse, underscoring the treatment's potential.

Reliable assessments by an independent Clinical Efficacy Adjudication Committee further corroborated these findings. The Committee unanimously agreed on the stark contrast in response rates between the AP-SA02 and placebo groups.

Beyond just response rates, the trial indicated expedited times to achieve negative blood cultures among patients treated with AP-SA02, alongside reductions in key biomarkers associated with poor outcomes in complicated bacteremia, thus reinforcing evidence of clinical efficacy.

Dr. Birx remarked on the innovative aspects of this clinical trial, emphasizing the successful development of high-titer phages allowing for safe and effective repetitious administration. It also points to the possibility of AP-SA02 effectively targeting biofilms and penetrating through antibiotic resistance mechanisms, a crucial hurdle in current bacterial therapies. The results validate Armata’s commitment to advancing phage therapy, taking significant strides toward potential commercialization.

In preparation for future developments, Armata is eager to initiate pivotal clinical trials, building on the promising data accumulated from the diSArm study. The expertise leveraged in the manufacturing process, upheld by compliant practices in California, further supports their capability to produce high-quality phage therapeutic products at scale. All active pharmaceutical ingredients remain in-house managed, ensuring the company can meet the growing demand for effective treatments against antibiotic-resistant infections.

Armata Pharmaceuticals stands pivotal in shaping the future landscape of phage therapy, buoyed by supportive partnerships and strong internal manufacturing capabilities. The notable progress made during the diSArm study highlights not only a breakthrough in treating Staphylococcus aureus bacteremia but also the immense potential of phage therapy in addressing pressing healthcare challenges, particularly antibiotic resistance in bacterial infections.

With these advances, Armata is poised to revolutionize therapeutic protocols in an era where antibiotic resistance looms as a critical global health threat.