Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults With Bacteremia Due to Staphylococcus Aureus

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

开始日期2022-04-26

申办/合作机构

Armata Pharmaceuticals, Inc.

[+1]

100 项与 AP-SA02 相关的临床结果

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100 项与 AP-SA02 相关的转化医学

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100 项与 AP-SA02 相关的专利（医药）

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项与 AP-SA02 相关的新闻（医药）

2024-11-13

·PRNewswire

Armata Pharmaceuticals Announces Third Quarter 2024 Results and Provides Corporate Update

LOS ANGELES, Nov. 13, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced financial results for its third quarter ended September 30, 2024, and provided a corporate update. Third Quarter 2024 and Recent Developments: Completed enrollment of the Phase 2 study ("Tailwind") of inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis ("NCFB") and chronic pulmonary Pseudomonas aeruginosa ("P. aeruginosa") infection. Topline data expected by year-end. Working towards initiating a pivotal bronchiectasis trial in 2025 for chronic pulmonary P. aeruginosa infection. Completed enrollment of Phase 1b/2a study ("diSArm") of intravenous AP-SA02 in patients with Staphylococcus aureus ("S. aureus") bacteremia. Topline data expected in the first quarter of 2025. Moving towards initiating a pivotal S. aureus bacteremia trial in 2025. Received $5.25 million of additional non-dilutive funding to support the diSArm study pursuant to a previously announced Department of Defense grant, received 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. Further advanced bacteriophage science through presentations and publications: Announced publication in Communications Biology describing the structure of a Pseudomonas phage, representative of a family present in the clincial candidate cocktail AP-PA02. Delivered a poster presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, in Kissimmee, Florida. Delivered an oral presentation on advancing bacteriophage therapy at Viruses of Microbes 2024, held July 15-19, in Cairns, Australia. Appointed life sciences accounting and finance veteran David House as Senior Vice President, Finance. Amended convertible debt and 2023 credit agreement to extend the maturity dates from January 10, 2025 to January 10, 2026. "During the third quarter, we completed enrollment of our Phase 2 Tailwind study of inhaled AP-PA02 in NCFB patients with chronic P. aeruginosa infection, and remain on-track to report topline data from this study by the end of this year," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "This will mark our second Phase 2 data readout for inhaled AP-PA02, following prior successful evaluation in patients with cystic fibrosis in the Phase 1b/2a SWARM-P.a. clinical trial last year. We plan to meet with the U.S. FDA to align on the design of a pivotal Phase 3 bronchiectasis study for inhaled AP-PA02 as a pulmonary disease therapeutic which we are working towards initiating in 2025." "Additionally, we have completed enrollment of our Phase 1b/2a diSArm study evaluating intravenous AP-SA02 as a potential treatment for S. aureus bacteremia. The high purity of Armata's intravenously-administered phage drug products enabled dose escalation to 2E11 PFU every 24 hours for five days, which was well-tolerated. We look forward to topline data in the first quarter of 2025 that should inform the optimal dose of AP-SA02 to be evaluated in a larger definitive efficacy study that we are planning to initiate in 2025." "With two Phase 2 data readouts expected near-term, we believe we continue to add to the body of evidence demonstrating the potential of phage therapy, either as an alternative to or in combination with current standard of care antibiotics, to combat antibiotic-resistant and difficult-to-treat bacterial infections. I am delighted with our progress to date, and look forward to potential major value inflection points in 2025 and beyond," Dr. Birx concluded. Third Quarter 2024 Financial Results Grant Revenue. The Company recognized grant revenue of $3.0 million for the three months ended September 30, 2024 as compared to $1.2 million in the comparable period in 2023, which represents MTEC's share of the costs incurred for the Company's AP-SA02 program for the treatment of S. aureus bacteremia. Research and Development. Research and development expenses for the three months ended September 30, 2024 were approximately $9.5 million as compared to approximately $8.0 million for the comparable period in 2023. The Company continues to invest in clinical related expenses associated with its primary development programs. General and Administrative. General and administrative expenses for the three months ended September 30, 2024 were approximately $3.2 million as compared to approximately $3.6 million for the comparable period in 2023. The decrease was mainly related to a decrease of $1.0 million in professional services during the third quarter of 2024, offset in part by an increase of $0.6 million in personnel related expenses. Loss from Operations. Loss from operations for the three months ended September 30, 2024 was approximately $9.8 million as compared to a loss from operations of approximately $10.3 million for the comparable period in 2023. Net Loss. The net loss for the third quarter of 2024 was $5.5 million, or $0.15 per share on both a basic and diluted basis, as compared to a net loss of $31.2 million, or $0.86 per share on both a basic and diluted basis, for the comparable period in 2023. The net loss for the quarter ended September 30, 2024 included non-cash gain from changes in fair value of convertible debt of $6.9 million, as compared to $15.8 million loss from changes in fair value of convertible debt for the quarter ended September 30, 2023. Cash and Equivalents. As of September 30, 2024, Armata held approximately $17.1 million of unrestricted cash and cash equivalents, as compared to $13.5 million as of December 31, 2023. As of November 13, 2024, there were approximately 36.2 million common shares outstanding. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of 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 cGMP manufacturing. 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 current Good Manufacturing Practices; 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 SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, 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 SOURCE Armata Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期财报临床3期

2024-08-26

·PRNewswire

Armata Pharmaceuticals Announces Presentation at the 2024 Military Health System Research Symposium

LOS ANGELES, Aug. 26, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that Mina Pastagia, M.D., MS, Chief Medical Officer, will deliver a poster presentation at the 2024 Military Health System Research Symposium (MHSRS), which is being held August 26-29 in Kissimmee, FL. The poster provides an overview of Armata's two distinct phage development programs, inhaled AP-PA02 (Pseudomonas aeruginosa bronchiectasis) and intravenous AP-SA02 (Staphylococcus aureus (S. aureus) bacteremia), which are being or have been evaluated in three distinct double-blind, placebo-controlled Phase 2 clinical trials. Regarding AP-SA02, Armata is currently advancing its Phase 1b/2a multiple ascending dose study (diSArm) of intravenous AP-SA02 as an adjunct to best available antibiotic therapy (BAT) compared to BAT alone. Enrollment of the diSArm study is 80% complete, and Armata anticipates completing enrollment by the end of 2024. The clinical development of AP-SA02 is supported by a $21.6 million Department of Defense grant, received 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. "We are excited to participate in this year's MHSRS and highlight the rigorously designed double-blind, placebo-controlled clinical trials that we are executing for both of our phage candidates," stated Dr. Pastagia. "Through our completed and ongoing Phase 2 trials, our phage candidates have been well tolerated, allowing us to evaluate higher phage doses that can increase the ability of our phages to fulfill their mechanism of action of attacking only pathogenic bacteria. This in turn is expected to provide Armata with the necessary data to inform how best to administer phage therapy and decrease the usage of broad-spectrum antibiotics so as to preserve the human microbiome in an effort to lower patient morbidity. We greatly appreciate the collaborative partnership with the NMRC and NAMD as well as MTEC for its financial support of our AP-SA02 program. We look forward to advancing both AP-SA02 and AP-PA02 into pivotal Phase 3 trials next year with the hope of introducing a distinct new class of anti-infectives to patient care." Summary: Multiple-dose administration of intravenous AP-SA02 and inhaled AP-PA02 have been well tolerated to date. Preliminary pharmacokinetic data suggests intravenous AP-SA02 is active in all subjects, with longer phage persistence in a significant subset of subjects potentially demonstrating a persistent reservoir of S. aureus bacteria (despite antibiotics) and in vivo amplification of the phages. This may garner increased clinical benefit for patients with difficult-to-treat S. aureus infections. Preliminary evidence supports inhaled AP-PA02 monotherapy as a viable alternative to inhaled antibiotics in Pseudomonas aeruginosa bronchiectasis. Promising data for both phage candidates is expected to be utilized for planning pivotal Phase 3 clinical trials in 2025. About MHSRS The MHSRS is the Department of Defense's foremost scientific meeting. It provides a venue for presenting new scientific knowledge resulting from military-unique research and development. The MHSRS is the premier military or civilian meeting that focuses specifically on the unique medical needs of the warfighter. The MHSRS provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related health care initiatives falling under the topic areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Information Sciences, Military Infectious Diseases, and Radiation Health Effects. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of 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 cGMP manufacturing. 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 current Good Manufacturing Practices; 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 SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, 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 Armata Pharmaceuticals, Inc. [email protected] 310-665-2928 x234 Investor Relations: Joyce Allaire LifeSci Advisors, LLC [email protected] 212-915-2569 SOURCE Armata Pharmaceuticals, Inc.

临床2期临床3期

2024-08-13

·PRNewswire

Armata Pharmaceuticals Announces Second Quarter 2024 Results and Provides Corporate Update

LOS ANGELES, Aug. 13, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced financial results for its second quarter ended June 30, 2024, and provided a corporate update. Second Quarter 2024 and Recent Developments: Announced completion of enrollment in its Tailwind Phase 2 clinical study of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. The last patient final follow-up visit occurred on August 7. Armata anticipates topline data from the Tailwind study in the second half of 2024. Received $5.25 million of additional non-dilutive funding from the U.S. Department of Defense pursuant to a previously-announced grant. The award is partially supporting advancement of the Phase 2a portion of the diSArm study of intravenous AP-SA02 as a potential treatment for Staphylococcus aureus (S. aureus) bacteremia. Further advanced bacteriophage science through presentations and publications: Delivered a presentation on advancing bacteriophage therapy at Viruses of Microbes 2024, which was held July 15-19, 2024, in Cairns, Australia. Completed the build-out of its advanced biologics manufacturing facility with five current good manufacturing practice ("cGMP") clean rooms, including a state-of-the-art automated fill and finish suite. "During the second quarter and subsequent period, we made meaningful progress across both of our clinical programs, keeping us on track to potentially initiate pivotal studies next year," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Regarding AP-PA02, which we are developing as an inhaled treatment for chronic P. aeruginosa lung infections, I am pleased to report that we recently completed enrollment and the last patient visit in our Phase 2 Tailwind study in subjects with NCFB, and we plan to announce topline data later this year." "For AP-SA02, we continued to advance our Phase 2a diSArm study of intravenous AP-SA02 as a potential treatment for S. aureus bacteremia. We are grateful to the Department of Defense for its ongoing financial support, which provides us with critical non-dilutive funding. We look forward to completing the diSArm study later this year and identifying the optimal dose of AP-SA02 to be tested in a larger definitive study." "Also, during the second quarter, we completed the build-out of our state-of-the-art cGMP manufacturing facility, giving us the ability to support our late-stage clinical trials, potential partnerships, and potential commercial production." "Our mission has long been the execution of rigorously designed, randomized clinical studies that demonstrate the safety and efficacy of our multi-phage candidates to support eventual registration, and I am very pleased with our sustained progress during the second quarter and through the first half of the year," Dr. Birx concluded. Second Quarter 2024 Financial Results Grant Revenue. The Company recognized no grant revenue for the three months ended June 30, 2024. The Company recognized approximately $1.0 million of grant revenue in the comparable period in 2023 which represents Medical Technology Enterprise Consortium's share of the costs incurred for the Company's AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. Research and Development. Research and development expenses for the three months ended June 30, 2024 were approximately $8.5 million as compared to approximately $8.3 million for the comparable period in 2023. The Company continues to invest in clinical related expenses associated with its primary development programs. General and Administrative. General and administrative expenses for the three months ended June 30, 2024 were approximately $3.4 million as compared to approximately $2.4 million for the comparable period in 2023. The increase was mainly related to an increase of $1.0 million in stock-based compensation as a result of increased awards granted during the first quarter of 2024. Loss from Operations. Loss from operations for the three months ended June 30, 2024 was $11.9 million as compared to a loss from operations of approximately $9.6 million for the comparable period in 2023. Cash and Equivalents. As of June 30, 2024, Armata held approximately $26.4 million of unrestricted cash and cash equivalents, as compared to $13.5 million as of December 31, 2023. As of August 13, 2024, there were approximately 36.2 million common shares outstanding. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of 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 cGMP manufacturing. 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 current Good Manufacturing Practices; 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 SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, 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 SOURCE Armata Pharmaceuticals, Inc.

临床2期财报临床1期

100 项与 AP-SA02 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
葡萄球菌感染	临床2期	美国	Armata Pharmaceuticals, Inc.	2022-05-23
金黄色葡萄球菌菌血症	临床2期	美国	Armata Pharmaceuticals, Inc.	2022-04-26
金黄色葡萄球菌菌血症	临床2期	澳大利亚	Armata Pharmaceuticals, Inc.	2022-04-26
菌血症	临床2期	美国	Disarm Therapeutics, Inc.初创企业	2022-01-30
假体关节感染	临床1期	美国	Armata Pharmaceuticals, Inc.	2022-08-01