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Azitra, Inc. Strengthens Global Intellectual Property Portfolio with Newly Granted and Allowed Patents

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Azitra, Inc. (NYSE American: AZTR) has strengthened its global intellectual property portfolio with newly granted and allowed patents. The company received a U.S. patent for a filaggrin-secreting strain of Staphylococcus epidermidis to treat atopic dermatitis, along with additional patent allowances in the U.S., Canada, and China. These patents protect compositions and methods for treating inflammatory skin diseases using recombinant microorganisms.

The newly issued U.S. patent addresses atopic dermatitis, which affects approximately 16.5 million people in the United States. Azitra is developing live biotherapeutic product candidates for various skin diseases, focusing on precision dermatology. The company's approach involves delivering missing proteins, such as filaggrin, to the skin using engineered bacteria.

Azitra's patent portfolio now includes 4 granted U.S. patents, 14 granted international patents, and numerous pending applications, strengthening its position in the field of precision dermatology.

Azitra, Inc. (NYSE American: AZTR) ha rafforzato il suo portafoglio globale di proprietà intellettuale con brevetti recentemente concessi e autorizzati. L'azienda ha ricevuto un brevetto statunitense per un ceppo di Staphylococcus epidermidis che secreta filaggrina per il trattamento della dermatite atopica, insieme ad ulteriori autorizzazioni di brevetto negli Stati Uniti, in Canada e in Cina. Questi brevetti proteggono composizioni e metodi per trattare malattie infiammatorie della pelle utilizzando microrganismi ricombinanti.

Il nuovo brevetto statunitense si occupa della dermatite atopica, che colpisce circa 16,5 milioni di persone negli Stati Uniti. Azitra sta sviluppando candidati per prodotti bioterapici vivi per varie malattie della pelle, concentrandosi sulla dermatologia di precisione. L'approccio dell'azienda prevede la somministrazione di proteine mancanti, come la filaggrina, alla pelle utilizzando batteri ingegnerizzati.

Il portafoglio di brevetti di Azitra include ora 4 brevetti statunitensi concessi, 14 brevetti internazionali concessi e numerose domande pendenti, rafforzando la sua posizione nel campo della dermatologia di precisione.

Azitra, Inc. (NYSE American: AZTR) ha fortalecido su cartera global de propiedad intelectual con patentes recientemente otorgadas y permitidas. La empresa recibió una patente estadounidense para una cepa de Staphylococcus epidermidis que secreta filaggrina para tratar la dermatitis atópica, junto con otras autorizaciones de patentes en los EE. UU., Canadá y China. Estas patentes protegen composiciones y métodos para tratar enfermedades inflamatorias de la piel utilizando microorganismos recombinantes.

La nueva patente estadounidense aborda la dermatitis atópica, que afecta a aproximadamente 16.5 millones de personas en los Estados Unidos. Azitra está desarrollando candidatos para productos bioterapéuticos vivos para diversas enfermedades de la piel, centrándose en la dermatología de precisión. El enfoque de la empresa implica la entrega de proteínas faltantes, como la filaggrina, a la piel utilizando bacterias ingenierizadas.

El portafolio de patentes de Azitra ahora incluye 4 patentes estadounidenses otorgadas, 14 patentes internacionales otorgadas y numerosas solicitudes pendientes, fortaleciendo su posición en el campo de la dermatología de precisión.

Azitra, Inc. (NYSE American: AZTR)는 글로벌 지식 재산권 포트폴리오를 강화했습니다 신규 인증 및 허가된 특허를 통해. 이 회사는 아토피 피부염 치료를 위한 필라그린 분비균주인 Staphylococcus epidermidis에 대한 미국 특허를 받았습니다. 또한 미국, 캐나다 및 중국에서 추가 특허 허가를 받았습니다. 이 특허는 재조합 미생물을 사용하여 염증성 피부 질환을 치료하기 위한 조성과 방법을 보호합니다.

새로 발급된 미국 특허는 아토피 피부염에 관한 것으로, 이는 미국에서 약 1,650만 명에게 영향을 미칩니다. Azitra는 정밀 피부과에 중점을 두고 다양한 피부 질환을 위한 생물 치료 제품 후보를 개발하고 있습니다. 이 회사의 접근법은 유전자 조작된 박테리아를 사용하여 필라그린과 같은 결핍된 단백질을 피부로 전달하는 것입니다.

Azitra의 특허 포트폴리오는 현재 4개의 승인된 미국 특허, 14개의 승인된 국제 특허 및 수많은 미결 특허 출원을 포함하여 정밀 피부과 분야에서의 입지를 강화하고 있습니다.

Azitra, Inc. (NYSE American: AZTR) a renforcé son portefeuille mondial de propriété intellectuelle avec des brevets nouvellement accordés et autorisés. L'entreprise a obtenu un brevet américain pour une souche de Staphylococcus epidermidis sécrétant de la filaggrine pour traiter la dermatite atopique, ainsi que d'autres autorisations de brevet aux États-Unis, au Canada et en Chine. Ces brevets protègent des compositions et des méthodes pour traiter les maladies inflammatoires de la peau en utilisant des microorganismes recombinants.

Le nouveau brevet américain concerne la dermatite atopique, qui touche environ 16,5 millions de personnes aux États-Unis. Azitra développe des candidats pour des produits biothérapeutiques vivants pour diverses maladies de la peau, en se concentrant sur la dermatologie de précision. La méthode de l'entreprise implique la livraison de protéines manquantes, telles que la filaggrine, à la peau à l'aide de bactéries génétiquement modifiées.

Le portefeuille de brevets d'Azitra comprend désormais 4 brevets américains accordés, 14 brevets internationaux accordés et de nombreuses demandes en attente, renforçant ainsi sa position dans le domaine de la dermatologie de précision.

Azitra, Inc. (NYSE American: AZTR) hat sein globales Portfolio an geistigem Eigentum gestärkt durch neu erteilte und zugelassene Patente. Das Unternehmen erhielt ein US-Patent für einen filaggrin-sezierenden Stamm von Staphylococcus epidermidis zur Behandlung von atopischer Dermatitis, zusammen mit zusätzlichen Patenterlaubnissen in den USA, Kanada und China. Diese Patente schützen Zusammensetzungen und Methoden zur Behandlung von entzündlichen Hauterkrankungen mit rekombinanten Mikroorganismen.

Das neu erteilte US-Patent befasst sich mit atopischer Dermatitis, die etwa 16,5 Millionen Menschen in den Vereinigten Staaten betrifft. Azitra entwickelt lebende biotherapeutische Produktkandidaten für verschiedene Hauterkrankungen mit Fokus auf präzise Dermatologie. Der Ansatz des Unternehmens besteht darin, fehlende Proteine wie Filaggrin mithilfe von gentechnisch veränderten Bakterien an die Haut abzugeben.

Das Patentportfolio von Azitra umfasst nun 4 erteilte US-Patente, 14 erteilte internationale Patente und zahlreiche anhängige Anträge und stärkt somit seine Position im Bereich der präzisen Dermatologie.

Positive
  • Granted U.S. patent for filaggrin-secreting strain of Staphylococcus epidermidis to treat atopic dermatitis
  • Additional patent allowances in U.S., Canada, and China for compositions and methods using recombinant microorganisms
  • Expanded global intellectual property portfolio with 4 granted U.S. patents and 14 granted international patents
  • Developing novel topical treatment for filaggrin-deficient diseases, addressing a market of 16.5 million people in the U.S.
  • Initiated first-in-human study of ATR-12 for adult Netherton syndrome patients
Negative
  • None.

Insights

Azitra, Inc.'s newly granted and allowed patents significantly enhance their global intellectual property portfolio, particularly in the realm of precision dermatology. The key patent covering a filaggrin-secreting strain of Staphylococcus epidermidis for the treatment of atopic dermatitis is crucial. This condition affects approximately 16.5 million people in the U.S. and represents an unmet medical need with no FDA-approved treatments. The ability to address filaggrin deficiency, a core issue in atopic dermatitis, could potentially place Azitra at the forefront of developing effective biotherapeutics for skin diseases. Additionally, expanding patent protections in major markets like China and Canada strengthens Azitra’s market position and potential for strategic partnerships or acquisitions.

The issuance and allowance of patents in multiple major markets, including the U.S., Canada and China, bolster Azitra, Inc.'s competitive edge and market reach. This broadened IP protection not only supports their current pipeline but likely increases investor confidence due to the reduced risk of IP-related litigation and the potential for exclusive market opportunities. The global skin disease therapeutics market is growing and precision dermatology represents a promising segment. By securing these patents, Azitra can leverage its innovative platform to potentially capture significant market share, particularly in regions with high prevalence of skin conditions needing novel treatments.

From a legal perspective, the newly granted and allowed patents provide a robust framework for protecting Azitra's innovations. The broad scope of the patents covering compositions and methods utilizing recombinant microorganisms for treating inflammatory skin diseases secures a strategic barrier against competitors. This legal fortification is critical in the biopharmaceutical industry, where proprietary technology can determine a company's success. Moreover, having patents granted and allowed in key jurisdictions like the U.S., Canada and China enhances Azitra's ability to enforce its IP rights internationally, which is important for maintaining market exclusivity and negotiating licensing deals.

  • Newly issued U.S. patent protects a filaggrin-secreting strain of Staphylococcus epidermidis for the treatment of atopic dermatitis. Issuance date was July 16, 2024
  • Newly allowed patents in the U.S. and China protect the composition of a filaggrin-secreting strain of Staphylococcus epidermidis
  • Newly allowed Canada patent protects a filaggrin-secreting strain of Staphylococcus epidermidis for a number of skin diseases, including atopic dermatitis
  • Atopic dermatitis is a high unmet need with no FDA-approved treatment option and affects approximately 16.5 million people in the United States
  • Broadens Azitra’s global intellectual property (IP) position for its platform using metagenomics and engineered skin bacteria for precision dermatology

BRANFORD, Conn.--(BUSINESS WIRE)-- Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. patent No. 12,036,248, covering future potential pipeline candidates for indications including atopic dermatitis, titled “Therapeutic treatment of skin disease with recombinant skin microorganisms.

The Company also announced three additional newly allowed patents in three countries, including the U.S., Canada, and China:

  • Methods and Compositions for Treating Inflammatory Skin Disease with Recombinant Microorganisms
    • U.S. Patent Application No. 16/121,903
    • Covers the composition of filaggrin-secreting strains of Staphylococcus epidermidis
  • Methods and Compositions for Treating Atopic Dermatitis with Recombinant Microorganisms
    • Canadian Patent Application No. 3067364
    • Covers the use of filaggrin-secreting strains of Staphylococcus epidermidis for atopic dermatitis and other skin diseases
  • Methods and Compositions for Treating Inflammatory Skin Disease with Recombinant Microorganisms
    • Chinese Patent Application No. 201880071303.9
    • Covers the composition of filaggrin-secreting strains of Staphylococcus epidermidis

Travis Whitfill, Azitra’s COO, co-founder, and inventor of the patents stated, "We are delighted to announce our second US patent issuance this year and three additional patent allowances in key markets in the U.S., Canada, and China. The indication addressed by the newly issued U.S. patent, atopic dermatitis, affects approximately 16.5 million people in the United States. There are numerous diseases associated with filaggrin deficiency, and the newly issued U.S. patent extends our protection to include a major market in the U.S., atopic dermatitis, particularly those with mild to moderate disease. Additionally, the new patent allowances in China and Canada extend our IP strength globally."

Azitra is developing live biotherapeutic product candidates intended to treat various skin diseases with precision dermatology. In many patients with atopic dermatitis, there is missing or abnormal filaggrin levels. Azitra is developing a novel topical treatment modality for filaggrin-deficient diseases that directly addresses the disease pathophysiology by delivering filaggrin to the skin. The strain consists of a functional unit of the human filaggrin protein with an attached cell penetrating peptide. The goal is to supplement the skin with stable delivery of filaggrin via topical application and deeper skin penetration with a cell penetrating peptide.

This modality of a topical live biotherapeutic consisting of a protein-secreting of S. epidermidis to deliver missing proteins is similar to Azitra’s ATR-12 product candidate, which delivers Lympho-epithelial Kazal-type-related inhibitor (LEKTI) for Netherton syndrome, caused by missing LEKTI. Azitra has initiated a first-in-human study of ATR-12 for adult Netherton syndrome patients (NCT06137157), which is now open for enrollment.

After issuance of the Canadian, Chinese and two US patents mentioned above, Azitra will hold 4 granted U.S. patents, 14 granted international patents, 9 pending U.S. patent applications, and 44 pending international patent applications.

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 issuance of patents relating to the three patent allowances and the expected benefits of the recently issued patent covering atopic dermatitis and Azitra’s development of live biotherapeutic product candidates intended to treat atopic dermatitis.

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, (i) the risk that we may not realize the expected benefits of the newly issue patent or the patents to be issued based upon the three patent allowances, (ii) if we do realize the expected benefits for such patents, we may not be able to protect our rights under such patents, (iii) we are in the early preclinical stages of developing our live biotherapeutic product candidates intended to treat atopic dermatitis and there can be no assurance that we will be able to advance any such product candidate to clinical trials or, if we do, that such clinical trials will be successful; (iv) we may fail to timely raise additional required funding as and when needed; and those other risks described our incorporated by reference in our prospectus dated July 15, 2024 filed with the SEC on July 15, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Company Contact

Norman Staskey

Chief Financial Officer

staskey@azitra.com

Hayden IR

James Carbonara

(646) 755-7412

james@haydenir.com

Source: Azitra, Inc.

FAQ

What new patent did Azitra (AZTR) receive for atopic dermatitis treatment?

Azitra received U.S. patent No. 12,036,248, which covers a filaggrin-secreting strain of Staphylococcus epidermidis for the treatment of atopic dermatitis.

In which countries did Azitra (AZTR) receive new patent allowances?

Azitra received new patent allowances in the United States, Canada, and China for compositions and methods using recombinant microorganisms to treat inflammatory skin diseases.

How many people in the United States are affected by atopic dermatitis, according to Azitra's (AZTR) press release?

According to Azitra's press release, atopic dermatitis affects approximately 16.5 million people in the United States.

What is the current status of Azitra's (AZTR) ATR-12 product candidate for Netherton syndrome?

Azitra has initiated a first-in-human study of ATR-12 for adult Netherton syndrome patients, which is now open for enrollment (NCT06137157).

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