A Phase 1b/2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of ATR-04 to Reduce the Severity of Epidermal Growth Factor Inhibitor Associated Papulopustular Rash

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period).
The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.

开始日期2024-01-01

申办/合作机构

Azitra, Inc.

100 项与 ATR-04 相关的临床结果

登录后查看更多信息

100 项与 ATR-04 相关的转化医学

登录后查看更多信息

100 项与 ATR-04 相关的专利（医药）

登录后查看更多信息

项与 ATR-04 相关的新闻（医药）

2024-11-12

·PRNewswire

Azitra, Inc. Announces Q3 2024 Financial Results and Provides Business Updates

BRANFORD, Conn., Nov. 12, 2024 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended September 30, 2024 and provided a business update. Q3 2024 and Recent Business Highlights: Completed a follow-on offering of $10 million in gross proceeds Dosed first Netherton syndrome patient with ATR-12 Submitted an IND to the FDA and received IND clearance for ATR-04 to treat skin rash from EGFR inhibitors Received Fast Track designation from the FDA for ATR-04 Presented positive preclinical data and the clinical plan of a Phase 1/2 clinical study of ATR-04 in a late-breaking presentation at the European Academy of Dermatology and Venereology (EADV) Congress Strengthened intellectual property (IP) portfolio with newly granted and allowed patents Francisco Salva, CEO of Azitra commented: "Azitra achieved a number of significant milestones in the third quarter of 2024 to propel our pipeline forward, highlighted by the dosing of the first patient with ATR-12 in our ongoing Netherton syndrome trial. Additionally during the quarter, we completed a follow-on offering of $10 million in gross proceeds, submitted an IND for ATR-04 for skin rash from epidermal growth factor receptor inhibitors (EGFRis), obtained IND clearance and Fast Track designation for ATR-04, and strengthened our IP portfolio. "With a clear roadmap, strong execution on two programs, and a dedicated team, Azitra is well-positioned to execute these milestones, deliver transformative therapies to patients in need, and ultimately maximize shareholder value." Pipeline and Anticipated Milestones Q1 2025: Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial Q1 2025: First patient dosed with ATR-04 for EGFRi rash in a Phase 1/2 trial YE 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected Financial Results for the Three Months Ended September 30, 2024 Service Revenue – Related Party: The Company generated $0 service revenue during the quarter ended September 30, 2024, compared to $310,700 for the comparable period in 2023. Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2024, were $1.0 million compared to $0.5 million for the comparable period in 2023. General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2024, were $1.9 million compared to $1.8 million for the comparable period in 2023. Net Loss was $1.0 million for the quarter ended September 30, 2024, compared to $1.9 million for the comparable period in 2023. Cash and cash equivalents: As of September 30, 2024, the Company had cash and cash equivalents of $7.3 million. About ATR-12 ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately 20,000 patients globally. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open Phase 1b clinical trial that is actively recruiting adult Netherton syndrome patients (NCT06137157). Azitra has identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints. About ATR-04 ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derived S. epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFR inhibitor ("EGFRi") associated rash, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi rash in the United States. Azitra has received Fast Track designation from the FDA for EGFRi associated rash and plans to initiate a Phase 1/2 clinical study in patients undergoing EGFRi rash in early 2025. About Azitra, Inc. Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the presentation of data from the Phase 1b study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, the timing of having a signed license agreement with Bayer, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to successfully complete our Phase 1b trial for ATR-12, we may experience delays in the initiation of our Phase 1/2 trial fpr ATR-04, ; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our prospectus dated July 23, 2024 filed with the SEC on July 25, 2024 in our most recent quarterly report on Form 10-Q filed with the SEC on November 12, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman Staskey Chief Financial Officer [email protected] Tiberend Strategic Advisors, Inc. Jon Nugent 205-566-3026 [email protected] SOURCE Azitra, 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1期财报快速通道

2024-09-24

·Business Wire

Azitra, Inc. Announces Late-Breaking Presentation at the European Academy of Dermatology and Venereology Congress

BRANFORD, Conn.--( BUSINESS WIRE )--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the upcoming late-breaking presentation related to ATR-04. The presentation by Dr. Mary Spellman will take place on Thursday, September 26, 2024, in a late-breaking oral session entitled “ Development of a Staphylococcus epidermidis strain for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity” at the European Academy of Dermatology and Venereology (EADV) Congress 2024 in Amsterdam. ATR-04 is a live biotherapeutic product candidate consisting of an S. epidermidis strain that was isolated from a healthy volunteer and engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin toxicity, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36 γ and S. aureus . There are approximately 150,000 patients suffering from EGFRi-induced skin toxicity in the United States. Azitra has an active IND for a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients with dermal toxicity due to EGFR inhibitors, and ATR-04 has received Fast Track designation from the FDA. The data in the oral presentation will showcase the preclinical development of ATR-04 and details around the planned Phase 1/2 clinical trial in patients with dermal toxicity due to EGFR inhibitors. The presentation will be available on Azitra’s website at https://ir.azitrainc.com/news-events/presentations . About Azitra, Inc. Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis , which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/ . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the presentation of data from the Phase 1b study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, the timing of having a signed license agreement with Bayer, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to successfully complete our Phase 1/2 trial for ATR-04 and preclinical studies of other product candidates and obtain required approval before commercialization; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described in our Form 10-Q filed with the SEC on August 12, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

快速通道临床1期临床研究微生物疗法

2024-09-18

·Business Wire

Azitra Receives Fast Track Designation for ATR-04 for Skin Rash from EGFR Inhibitors

BRANFORD, Conn.--( BUSINESS WIRE )--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for topically applied ATR-04 to treat moderate to severe Epidermal Growth Factor Receptor inhibitor (EGFRi) associated dermal toxicity. Francisco Salva, Azitra’s CEO, stated, "We are thrilled to announce the FDA has granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash. Many cancer patients receive EGFR inhibitors, which often have significant side effects, resulting in rashes that require off-label treatment with antibiotics, steroids or other medications, or discontinuation of EGFRi therapy. The skin toxicity creates a high burden for these cancer patients, with a profound impact on their quality of life. We look forward to potentially accelerating the development of ATR-04 to treat this condition.” The FDA's Fast Track program aims to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant, unmet medical needs. This may include more frequent meetings with the FDA and eligibility for accelerated approval or rolling review. ATR-04 is a live biotherapeutic product candidate containing an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin rash, which is caused by the suppression of skin immunity and subsequent inflammation and often elevated levels of IL-36 γ and S. aureus. Approximately 150,000 patients are affected by EGFRi-induced skin toxicity in the United States, representing a >$1 billion market opportunity. Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients with dermal toxicity due to EGFR inhibitors by the end of 2024. About Azitra, Inc. Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis , or S. epidermidis , which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/ . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the clinical development of our ATR-04 product candidate and the expected benefits of the FDA’s grant of Fast Track designation for ATR-04. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that: we may not realize the potential benefits of the FDA’s grant of Fast Track designation for ATR-04; we may fail to successfully complete our Phase 1/2 trial for ATR-04 and preclinical studies of other product candidates; we may not be able to obtain additional working capital with which to continue our current operations and clinical trials as and when needed; success in early phases of preclinical and clinical trials do not ensure later clinical trials will be successful; no drug product incorporating our engineered proteins or topical live biotherapeutic products has received FDA premarket approval or otherwise been incorporated into a commercial drug product; and those other risks disclosed or incorporated in the section “Risk Factors” included in our Form 10-Q filed with the SEC on August 12, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

快速通道临床研究

100 项与 ATR-04 相关的药物交易

登录后查看更多信息