filaggrin

CHENGDU, China, April 29, 2024 /PRNewswire/ -- Technoderma Medicines, Inc. ("the Company"), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing patients in its Phase 2a clinical trial (NCT06363461) of topical TDM-180935 ointment. This clinical trial in the Atopic Dermatitis (AD) program includes 8 weeks dosing of two different active formulation strengths and placebo in a study entitled, "A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients". It is a randomized, vehicle-controlled, parallel group comparison study with an open-label PK sub-study. Objectives are to evaluate the safety and efficacy of topical TDM-180935 as well aspharmacokinetics. Seven U.S. clinical sites are currently participating in this study under an open IND with FDA. Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, "We expect the current study to support Proof-of-Concept for TDM-180935 regarding efficacy and to guide choice of formulation strength(s) appropriate for continued development in our AD program. We are encouraged by the selective advantages that maybe provided by TDM-180935 as a potent JAK1/Tyk2 small molecule inhibitor." "We are pleased with the excellent toleration and minimal systemic absorption already exhibited by TDM-180935 ointment in Phase 1 development and now look forward to assessing its preliminary efficacy in Atopic Dermatitis. The advancement of this second program in our portfolio into Phase 2 development validates our capabilities in developing multiple pipeline products for treatment of dermatologic diseases," said Zengquan Wang, Chief Executive Officer at Technoderma Medicines. "We are working to bring a steady stream of pipeline products into clinical testing." About TDM-180935 TDM-180935 is a small molecule drug candidate being developed as a topical drug for treatment of Atopic Dermatitis. As a potent JAK1/Tyk2 small molecule inhibitor, it may offer significant advantages regarding efficacy and safety compared to existing topical treatments. Preclinical assessment of TDM-180935 has demonstrated efficacy in multiple models and that it is well-suited for topical administration. Functional cell assays demonstrate that TDM-180935 can effectively suppress both keratinocyte- and T cell-derived pathogenic pathways characteristic for Atopic Dermatitis. Testing in rats and minipigs demonstrated favorable toxicology and toxicokinetic profiles. Phase 1 clinical testing of topical TDM-180935 ointment has demonstrated excellent toleration and minimal systemic absorption. About Atopic Dermatitis (AD) Atopic Dermatitis (AD), also called eczema, is a chronic relapsing pruritic inflammatory skin disorder that typically affects the face, neck, hands and feet, and flexor aspects of extremities. Depending on disease stages (acute, subacute, chronic), typical AD lesions include redness, swelling, cracked or excoriated skin, scaly erythema or plaques with or without exudates, and lichenification, accompanied by severe pruritus and skin dryness. Repeated scratching triggers a self-perpetuating itch-scratch cycle, which can have a significant impact on quality of life. The worldwide prevalence of AD is estimated to be 15-20% in children and 1-3% in adults, and the incidence has increased by 2- to 3-fold during the past decades in industrialized countries. The pathogenesis of AD involves four major aspects: disruption of skin barrier function, exposure to allergens, microbial infection, and dysregulated immune function. There are two major risk factors of developing AD: one is the genetic defect in the gene FLG encoding profilaggrin, the precursor of filaggrin protein present in the granular layer of the epidermis where it brings structural proteins together to create a strong barrier matrix; the other major risk factor is a family history of atopic diseases such as food allergy, allergic rhinitis, and asthma. About Technoderma Medicines Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company located in Chengdu Tianfu BioPark, Sichuan, China. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Psoriasis and Lupus Erythematosus. Its "first-in- class" small molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia successfully completed Phase 2a clinical testing and is further advancing in development. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis completed Phase 1 clinical testing with a favorable safety profile and is now entering Ph2a testing. The pipeline targets dermatologic indications. INVESTOR AND MEDIA CONTACT Technoderma Medicines, Inc. Zengquan Wang, PhD, CEO [email protected] SOURCE Technoderma Medicines

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 issued U.S. patent No. 11,850,267 covering future potential pipeline candidates for indications including ichthyosis vulgaris, titled “Methods and compositions for treating skin disease with recombinant microorganisms.” Travis Whitfill, Azitra’s COO, co-founder, and inventor of the patent stated, "Securing this patent is crucial for expanding our pipeline. Importantly, the indication addressed by this patent, ichthyosis vulgaris (IV), a chronic, scaly skin disease with no FDA-approved treatment option and affects approximately 1.3 million people in the United States. This new patent issuance reinforces the value of our platform for precision dermatology and our commitment to patient populations with no FDA-approved treatment options." Azitra is developing live biotherapeutic product candidates intended to treat ichthyosis vulgaris, a disease caused by missing or abnormal filaggrin levels. Azitra is developing a novel topical treatment modality for IV 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 ). Azitra’s growing patent portfolio now has three granted patents in the US with numerous additional applications pending globally to further expand its IP position. 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 benefits of the recently issued patent covering ichthyosis vulgaris and Azitra’s development of live biotherapeutic product candidates intended to treat ichthyosis vulgaris. 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, we are in the early preclinical stages of developing our live biotherapeutic product candidates intended to treat ichthyosis vulgaris 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; we may fail to timely raise additional required funding as and when needed; and those other risks described in our prospectus dated June 15, 2023 filed with the SEC on June 21, 2023. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

CHENGDU, China, Dec. 4, 2023 /PRNewswire/ -- Technoderma Medicines, Inc. ("the Company"), a clinical stage biopharmaceutical company, is pleased to report that the Company has completed a Phase 1 clinical trial (NCT05525468) of TDM-180935 topical ointment for Atopic Dermatitis (AD). This first clinical trial in the AD program included single dose and multidose escalation cohorts in a study entitled, "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects". Study objectives were to evaluate safety and pharmacokinetics of topical TDM-180935; one U.S. clinical site participated in this study under an open IND with FDA. All strengths of TDM-180935 (0.25%-2.0%) were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-180935 for 4 weeks over the range of doses studied produces extremely low to no systemic exposure. Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, "We are excited to see that TDM-180935 has met our expectations of a favorable safety profile in the current Phase 1 testing. As a potent JAK1/Tyk2 small molecule inhibitor, it may offer significant advantages regarding efficacy and safety compared to existing topical treatments for Atopic Dermatitis." "This is a major milestone for the Company as we can now transition our second clinical program into Phase 2. We continue to build a robust and sustainable pipeline of drug candidates in multiple phases of clinical development," said Zengquan Wang, PhD, Chief Executive Officer at Technoderma Medicines. "We are well on our way to produce a portfolio of dermatology drug candidates." About TDM-180935 TDM 180935 is a small molecule drug candidate being developed as a topical drug for treatment of Atopic Dermatitis. It functions as a potent JAK1/Tyk2 small molecule inhibitor. Preclinical assessment of TDM-180935 has demonstrated efficacy in multiple models and that it is well-suited for topical administration. Functional cell assays demonstrate that TDM-180935 can effectively suppress both keratinocyte- and T cell-derived pathogenic pathways characteristic for Atopic Dermatitis. Testing in rats and minipigs demonstrated favorable toxicology and toxicokinetic profiles. About Atopic Dermatitis (AD) Atopic Dermatitis (AD), also called eczema, is a chronic relapsing pruritic inflammatory skin disorder that typically affects the face, neck, hands and feet, and flexor aspects of extremities. Depending on disease stages (acute, subacute, chronic), typical AD lesions include redness, swelling, cracked or excoriated skin, scaly erythema or plaques with or without exudates, and lichenification, accompanied by severe pruritus and skin dryness. Repeated scratching triggers a self-perpetuating itch-scratch cycle, which can have a significant impact on quality of life. The worldwide prevalence of AD is estimated to be 15-20% in children and 1-3% in adults, and the incidence has increased by 2- to 3-fold during the past decades in industrialized countries. The pathogenesis of AD involves four major aspects: disruption of skin barrier function, exposure to allergens, microbial infection, and dysregulated immune function. There are two major risk factors of developing AD: one is the genetic defect in the gene FLG encoding profilaggrin, the precursor of filaggrin protein present in the granular layer of the epidermis where it brings structural proteins together to create a strong barrier matrix; the other major risk factor is a family history of atopic diseases such as food allergy, allergic rhinitis, and asthma. About Technoderma Medicines Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company. The Company was originally located in Jiaxing Xiuzhou Biomedicine Guoqian Park, China, and recently relocated to Chengdu Tianfu BioPark, Sichuan, China. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Psoriasis and Lupus Erythematosus. Its "first-in-class" small molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia is currently completing Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has now completed Phase 1 clinical testing. The pipeline targets dermatologic indications. INVESTOR AND MEDIA CONTACT Technoderma Medicines, Inc. Zengquan Wang, PhD, CEO [email protected] SOURCE Technoderma Medicines