Armata Pharmaceuticals Announces Positive Topline Data from the Phase 1b/2a diSArm Study of Intravenously Administered AP-SA02 in Complicated Staphylococcus aureus Bacteremia
All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population met
AP-SA02 arm significantly improved clinical outcomes and prevented relapse compared to best available antibiotic
therapy
No treatment-related serious adverse events were observed with repetitive intravenous dosing
LOS ANGELES, May 19, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ('Armata' or the 'Company'), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced positive topline results from its Phase 1b/2a diSArm trial which evaluated AP-SA02, a novel intravenous ('IV') administered multi-phage therapeutic for the treatment of Staphylococcus aureus ('S. aureus') bacteremia ('SAB'), in the intent-to-treat ('ITT') population.
'This trial and these data are what the field of phage therapy has been eagerly awaiting for over a decade and represent a critical leap forward for Armata and for the role of bacteriophages in combating life-threatening systemic infections,' stated Dr. Deborah Birx, Chief Executive Officer of Armata.
The diSArm study ( NCT05184764 ) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy ('BAT') compared to BAT alone (placebo) for the treatment of adults with complicated SAB.
Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo.
AP-SA02, administered IV every six hours for five days, was well-tolerated, with no serious adverse events related to the study drug. Two subjects had adverse events that were possibly related to the study drug: one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin.
The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) Test of Cure ('TOC') for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study ('EOS'), defined as four weeks following the end of IV BAT.
A statistically significant increase in investigator-assessed responder rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%) versus placebo (58%) (p = 0.047). At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent phase 3 trials. Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive S. aureus ('MSSA') or methicillin-resistant S. aureus ('MRSA'). All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above.
Supporting the investigator assessment, clinical outcome was assessed by the Clinical Efficacy Adjudication Committee, comprised of leading doctors in the bacteremia field, who agreed that subjects who received placebo had a 22% and 25% non-responder rate at TOC with BAT and at EOS, respectively, while 100% of the subjects who received AP-SA02 clinically responded (p = 0.025: TOC BAT; p = 0.020: EOS). Additionally, faster time to a negative blood culture and decline of key predictors of mortality and complications in SAB, including interleukin-10 and C-reactive protein, support the improved responder rates in subjects treated with AP-SA02.
'This clinical trial is groundbreaking in two fundamental ways: firstly, this is the first clear evidence in a randomized controlled trial of the efficacy of phage against a serious systemic pathogen that is responsible for significant morbidity and mortality in the United States, and secondly, Armata was able to successfully produce high titer phage with high purity allowing for repetitive IV administration every six hours without significant safety concerns,' continued Dr. Birx.
'We previously demonstrated the persistence of AP-SA02 in the IV space on multiple days one hour post IV push. Critically, these trial results support AP-SA02 homing to different sites of infection, presumably penetrating biofilms, and infecting and lysing the target S. aureus bacteria, independent of antibiotic resistance patterns and site of infection.'
'These data, including the favorable safety profile of AP-SA02, warrant that we move as rapidly as possible towards initiation of a pivotal trial. I am grateful to the patients who participated in this study, our excellent trial sites, and the unrelenting commitment of the Armata team. Finally, this progress and this initial breakthrough would not have been possible without ongoing support from Innoviva and the U.S. Department of Defense.'
'Importantly, Armata has developed the capacity to manufacture drug product at its cGMP facility in California. All Active Pharmaceutical Ingredients are maintained in house and Armata's current proprietary manufacturing process can produce over 10,000 full courses of phage therapy annually, distributed from its facility, consistent with supporting the need to onshore biomedical breakthroughs needed by the American people,' Dr. Birx concluded.
Armata's latest corporate presentation with topline results from the Phase 1b/2a diSArm study can be found here.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific current Good Manufacturing Practices ('cGMP') manufacturing to support full commercialization.
Forward Looking Statements
This communication contains 'forward-looking' statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant cGMP; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption 'Risk Factors' and elsewhere in Armata's filings and reports with the U.S. Securities and Exchange Commission (the 'SEC'), including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2025, and in its subsequent filings with the SEC.
Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Pierre Kyme
[email protected]
310-665-2928
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
[email protected]
212-915-2569
View original content to download multimedia: https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-positive-topline-data-from-the-phase-1b2a-disarm-study-of-intravenously-administered-ap-sa02-in-complicated-staphylococcus-aureus-bacteremia-302458664.html
SOURCE Armata Pharmaceuticals, Inc.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Fox News
34 minutes ago
- Fox News
NEWT GINGRICH: Pay less, know more — Trump is slashing red tape and lowering your healthcare costs
One of the boldest and most consistent themes in President Donald J. Trump's healthcare agenda is his determination to reduce the role and power of middlemen. From insurance companies to pharmacy benefit managers (PBMs) – and even hospitals –these intermediaries profit from the inefficiencies of our bloated health system. The result is higher costs for American families. As I explain in my new book, "Trump's Triumph: America's Greatest Comeback," the U.S. healthcare system isn't expensive just because care is costly. It's expensive because the system is complex – by design. The third-party payment structure, whether public or private, adds layers of bureaucracy. This opens the door for middlemen to offer supposed solutions that serve their own bottom lines – not patients. It's a vicious cycle: more rules lead to more middlemen, which lead to even more rules, red tape, and rising costs. President Trump understood this – and he took action. In his first term, he issued a groundbreaking executive order on price transparency. For the first time, hospitals were required to disclose the real cost of procedures, enabling patients to compare prices before receiving care. While the Biden administration weakened enforcement, Trump doubled down in his second term with an even stronger push for what he called "radical transparency." Radical transparency is the antidote to healthcare's worst inefficiencies. When patients and employers can see wide price differences for the same procedures – even within the same hospital system – the games played behind the scenes get exposed. These inflated prices often have little to do with quality and everything to do with how well insurers negotiate – or how many middlemen take a cut. The same is true for prescription drugs. PBMs – giant corporations that control which drugs are covered and at what cost – use their market power to inflate prices. Three PBMs control 80 percent of the market. They're often subsidiaries of major insurers, forming vertically integrated monopolies. New data from the Pacific Research Institute shows that most PBMs skim more money off high-cost prescriptions than European countries charge. It's no wonder Americans are paying more. Hospitals play a role as well. Many exploit a well-intentioned federal program known as 340B, which allows them to purchase drugs at steep discounts. Instead of passing the savings to patients, they bill insurers full price and pocket the difference. The program was meant to expand care for low-income patients, but there's little oversight to ensure this happens. President Trump's recent executive order on drug pricing targets this broken system. By creating a pathway for manufacturers to sell directly to patients, health plans, pharmacies, and clinics – without the markup – he's offering a way to bypass the middlemen. This isn't theory – it's already working. When insulin makers launched direct-to-consumer programs, they sold the same drug at one-fourth the price patients were paying through insurance – while still making a profit. That's the power of real market competition – without a single government price control. This stands in sharp contrast to the Left's top-down vision. Whether it's price controls, centralized purchasing, or government-run insurance, the left's answer is always more bureaucracy. But more bureaucracy means more complexity – and more room for middlemen to thrive. Perhaps the most visionary part of President Trump's health care agenda is his call to Make America Healthy Again. For decades, we've operated a "sick care" system focused on treating illness after it strikes. Trump's approach is different. It emphasizes prevention, lifestyle, and personal responsibility – turning Americans from passive recipients into active participants in their own health. In this model, the government's role isn't to run the system but to create an environment in which patients and doctors can lead – with access to better tools, more transparency, and useful information. That means clearer labeling for ultra-processed foods, ensuring gold standard scientific data free of conflicts of interest, and addressing environmental factors that contribute to chronic disease. These kinds of structural reforms empower people to make informed choices and live healthier lives – without mandates or micromanagement. It's a model that eliminates the ultimate middleman: the system itself. President Trump's leadership has laid the groundwork for a transparent, patient-centered, free-market healthcare system. But the job isn't done. Congress should join him in continuing this fight – not just to lower costs, but to restore power to the American people. America deserves a healthcare system that benefits Americans – not industry middlemen.
Washington Post
38 minutes ago
- Washington Post
Top CDC covid vaccine adviser quits after RFK Jr. ended recommendations
A top coronavirus vaccine adviser at the Centers for Disease Control and Prevention has resigned, citing concerns that she could no longer help vulnerable people after federal health officials rescinded long-standing recommendations to immunize children and pregnant women. Lakshmi Panagiotakopoulos said in an email to colleagues Tuesday that she made a 'personal decision' to quit the CDC after 12 years.
CBS News
39 minutes ago
- CBS News
Man charged in Palm Springs fertility clinic bombing after being arrested by FBI at New York's JFK airport
A man was charged Wednesday in connection with last month's bombing outside a fertility clinic in Palm Springs, California, after being apprehended in Europe and flown to New York City, where he was he was arrested overnight, authorities said. Daniel Park, 32, of Washington state is charged with providing and attempting to provide material support to a terrorist, U.S. Attorney Bilal Essayli announced during a news conference. Park is accused of shipping approximately 180 pounds of ammonium nitrate — commonly used as a precursor to construct homemade explosives — to the bomber, who was identified by officials as 25-year-old Guy Bartkus. Bartkus died in the blast outside the American Reproductive Centers fertility clinic on May 17. Four other people were injured in the explosion. Essayli said evidence shows Park and Bartkus shared extremist beliefs. According to the criminal complaint filed Wednesday, "Bartkus's attack was motivated by his pro-mortalism, anti-natalism, and anti-pro-life ideology, which is the belief that individuals should not be born without their consent and that non-existence is best." Investigators said Park also paid for an additional 90 pounds of ammonium nitrate that was shipped to Bartkus in the days leading up to the bombing. Park spent approximately two weeks visiting Bartkus' residence in Twentynine Palms, California, in late January and early February and ran "experiments" in his garage, Essayli said. FBI Assistant Director Akil Davis, in charge of the bureau's Los Angeles field office, said Park was charged because of his contributions to the bomb. "Park was in possession of an explosive recipe that was similar to the Oklahoma City bombing," Davis told reporters, referring to the 1995 attack on the Alfred P. Murrah Federal Building in downtown Oklahoma City that killed 168 people. "We believe that Park had knowledge of how to create an ANFO bomb, ammonium-nitrate-fuel-oil bomb." The FBI and other law enforcement personnel gather evidence a day after a bomb exploded near a reproductive health facility in Palm Springs, California, May 18, 2025. Reuters/David Swanson Park flew to Warsaw, Poland, on May 21, a few days after the bombing, Davis said. Polish authorities detained Park at the request of U.S. officials on Friday. He was flown back to the U.S. and taken into custody by American authorities at New York's John F. Kennedy International Airport overnight. Park is scheduled to appear in federal court in Brooklyn, New York, Wednesday afternoon. He is expected to be prosecuted in Los Angeles. Four Polish border guards were with Park when he was taken back to the U.S., and two members of the FBI flying squad were also on the flight, according to two senior U.S. officials with direct knowledge of the investigation. Park consented to speak with the FBI at JFK and was interviewed by them there. Police in Palm Springs said the bomber backed his Ford Fusion into a parking spot outside the clinic before the powerful explosion left a crater on the morning of May 17. The explosion could be felt more than a mile away from the blast zone, the FBI said. The vehicle exploded outside American Reproductive Centers, a fertility clinic with a full-service IVF lab that dd not perform abortions. The blast caused significant damage to the building. The facility also lost power, but it was restored in time so no embryos were lost in the attack. The clinic reopened about two weeks later at a new location. The FBI believed that the bombing was premeditated and called the attack an "intentional act of terrorism." Detectives said they believed Bartkus acted alone at the site of the attack, but said they were scouring his online chats to learn whether anyone helped him buy parts or refine the design of the bomb. Investigators said the blast pattern shows that the device was far more damaging than a low-grade explosive such as fireworks. The FBI said Bartkus had access to a large quantity of commercially available chemical products that could be combined to create a homemade explosive device. Twentynine Palms is home to a large Marine Corps base about an hour's drive from Palm Springs. contributed to this report.
