A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects With Androgenetic Alopecia

Randomized, double-blind, vehicle-controlled, parallel group, multi-dose study of TDM-105795 in male subjects with androgenetic alopecia

Start Date06 Mar 2023

Sponsor / Collaborator

Technoderma Medicines, Inc.

[+1]

NCT05244980

/ CompletedPhase 1

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects With Androgenetic Alopecia (AGA)

Multi-center, randomized, double-blind, vehicle-controlled, parallel group, multi-dose escalation study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA).

Start Date01 Feb 2022

Sponsor / Collaborator

Technoderma Medicines, Inc.

[+1]

NCT04913519

/ CompletedPhase 1

A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Dose TDM-105795 Topical Solution in Healthy Male Subjects With AGA

Multi-center, fixed volume, randomized, double-blind, vehicle-controlled, parallel group, dose escalation comparison study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA).

Start Date27 Apr 2021

Sponsor / Collaborator

Technoderma Medicines, Inc.

[+1]

100 Clinical Results associated with TDM-105795

100 Translational Medicine associated with TDM-105795

100 Patents (Medical) associated with TDM-105795

News (Medical) associated with TDM-105795

12 Jun 2024

·www.prnewswire.com

Latest Updates of Viva Biotech's Portfolio Companies

HONG KONG, June 12, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. VivaVision Forges Strategic Alliance with Renhe Shanliang, and Intitated Their Domestic Phase III Trial for VVN001 On June 6th, World Eye Health Day, a themed event was held in Shanghai. At this grand occasion, guests witnessed the signing of a joint venture agreement between VivaVision, invested and incubated by Viva BioInnovator (VBI), and Jiangxi Shanliang Pharmaceutical Co., Ltd. The two parties will join forces to build a renowned Chinese brand for contact lens care products. Back on March 16th, VivaVision had announced that the initiation meeting for the domestic Phase III clinical trial of VVN001 eye drops - their independently developed dry eye treatment, a LFA-1 antagonist - was successfully convened in Shanghai, marking the official setting sail of the Phase III clinical trial. QurAlis Grants Lilly Exclusive Global License for QRL-204 CAMBRIDGE, Mass., June 3rd, 2024–QurAlis Corporation ("QurAlis"), invested and incubated by Viva BioInnovator (VBI), recently announced that it has entered into an exclusive license agreement with Eli Lilly and Company ("Lilly") in which QurAlis is granting Lilly global rights to develop and commercialize QRL-204, a potentially best-in-class splice-switching antisense oligonucleotide (ASO) designed to restore UNC13A function in amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Under the terms of the agreement, QurAlis granted Lilly an exclusive, worldwide license to develop and commercialize QRL-204 and other UNC13A-targeting compounds in exchange for an upfront payment of $45 million to QurAlis, plus an additional equity investment. QurAlis is also eligible for future milestone payments of up to $577 million and tiered royalties on net sales. Arthrosi Announces Multiple Presentations at the European League Against Rheumatism (EULAR) Congress 2024 SAN DIEGO, May 30th, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and Tophi in patients with gout. Recently they announced the acceptance of two presentations, including one poster tour at the European League Against Rheumatism (EULAR) Congress 2024 meeting, being held in Vienna, Austria on June 12-15. Lucy Therapeutics Secures New Funding to Advance New Alzheimer's and Parkinson's Treatments WALTHAM, Mass.--(BUSINESS WIRE)--Lucy Therapeutics, Inc. (LucyTx), incubated and invested by Viva BioInnovator (VBI), announced it has raised $12.5 million in additional funding led by existing investors Engine Ventures and Safar Partners with new participation from Bill Gates, Parkinson's UK, and the Michael J. Fox Foundation, which provided a $2 million non-dilutive grant. The fresh capital brings LucyTx's total funding to date to more than $36 million. The investments will further the company's research programs for Alzheimer's and Parkinson's diseases and continue its development of a novel drug target for Rett syndrome. Technoderma Medicines Initiates Phase 2 Clinical Trial for TDM-180935, a Novel Drug for Atopic Dermatitis/Eczema, and Officially Establishes Presence at Chengdu Tianfu International Bio-Town On April 29th, 2024, Technoderma Medicines Inc., ("Technoderma Medicines"), a clinical-stage biotech company developing innovative drugs that is invested and incubated by Viva BioInnovator (VBI), officially announced the initiation of its Phase 2 clinical trial (NCT 06363461) for TDM-180935, a topical ointment for atopic dermatitis/eczema, with patients beginning treatment. Previously, on April 20th, Thyrologics officially established its presence at the Chengdu Tianfu International Bio-Town. Multipeptide Screening Integrated with Biochips, Unveiling New Strategies of XLEMENT and Healthytide On March 27th, 2024, two leading companies in the biopharmaceutical industry - Hangzhou Healthytide Biotechnology Co., LTD. (hereinafter referred to as "Healthytide") and XLEMENT, which is invested incubated by Viva BioInnovator (VBI), announced a strategic cooperation agreement to jointly advance technological innovation and breakthroughs in the field of peptide drug development. Healthytide brings its single-molecule peptide diversity library to the table, while XLEMENT contributes its innovative and industry-leading biochip technology platform to support the collaboration. About VivaVision Biotech VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. VivaVision's current pipeline includes VVN001 for treating dry eye syndrome, VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. VivaVision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases. For more info, visit . About QurAlis Corporation QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis' proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients. For more information, please visit or follow us on Twitter @QurAlisCo. About Arthrosi Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2b data showing industry-leading efficacy rates and superior safety profiles. About Lucy Therapeutics Lucy Therapeutics is a private biotechnology company in Waltham, MA, founded by Amy Ripka, Ph.D., in 2017, dedicated to unraveling the complex and interrelated biological processes driving mitochondrial dysfunction and addressing them to slow and stop the diseases they cause. Sitting at the center of genetics and metabolism, Lucy Therapeutics is leading the change in how we think about mitochondria and the intersecting pathways that play critical roles in human health and disease, particularly those of the central nervous system, including Parkinson's disease and Rett syndrome. For more information, visit lucytherapeutics.com. 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 Biomed Town, Chengdu, Sichuan Province, 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 in Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis is now in Phase 1 clinical testing. The pipeline targets dermatologic indications. About XLEMENT As an Innovator in the field of biopharmaceutical R&D and health diagnostics, Liangzhun has independently developed and launched the pioneering next-generation ultra-surface plasmon resonance detection "MetaSPR Biochip Technology". SOURCE Viva Biotech Holdings

Phase 2License out/inPhase 3Phase 1Oligonucleotide

29 Apr 2024

·www.prnewswire.com

Technoderma Medicines Advances TDM-180935 Atopic Dermatitis Clinical Program with Phase 2 Trial

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

Phase 1Phase 2Clinical Result

05 Feb 2024

·www.prnewswire.com

Technoderma Medicines Phase 2 Clinical Trial of TDM-105795 Demonstrates Hair Growth in Androgenetic Alopecia

CHENGDU, China, Feb. 5, 2024 /PRNewswire/ -- Technoderma Medicines, Inc. ("the Company"), a clinical stage biopharmaceutical company, is pleased to report that the Company has completed its Phase 2a clinical trial (NCT05802173) of TDM-105795 topical solution for Androgenetic Alopecia (AGA). This Proof-of-Concept clinical trial in the AGA program included daily dosing for four months in a study entitled, "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects with Androgenetic Alopecia". Study objectives were to evaluate preliminary efficacy, safety and pharmacokinetics of topical TDM-105795; thirteen U.S. clinical sites participated in this study under an open IND with FDA. Evaluation of efficacy by measurement of non-vellus Target Area Hair Count (TAHC) showed mean changes from baseline of 24.3 hairs with the high label strength (0.02%) and 20.3 hairs with the low label strength (0.0025%) topical solution, compared to 14.0 hairs with placebo in 1 cm2 test areas; randomization was 1:1:1 with 71 patients enrolled. Both label strengths of TDM-105795 were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-105795 topical solution at either dose produced 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-105795 in the current Phase 2 testing has demonstrated hair growth in AGA with a very favorable safety profile. We look forward to moving the clinical program forward to better assess how longer-term treatment is able to provide global improvement in hair coverage." "This is another major milestone for the Company that further increases confidence in our pipeline programs to produce and develop clinically useful new chemical entities in dermatology," said Zengquan Wang, PhD, Chief Executive Officer at Technoderma Medicines. "We are committed to developing a portfolio of innovative dermatology drug candidates." About TDM-105795 TDM-105795 is a small molecule drug candidate being developed as a topical drug for treatment of Androgenetic Alopecia. As a potent thyromimetic, it may offer significant advantages regarding efficacy and safety compared to existing treatments. Preclinical assessment of TDM-105795 indicates that it has poor systemic absorption following topical application and a short elimination half-life, features well-suited to avoid unwanted systemic effects. Moreover, in vivo efficacy studies in C3H mice showed that TDM-105795 was able to potently stimulate hair growth in a dose-dependent manner when applied topically. This is likely because TDM-105795 is able to activate dormant hair follicle stem cells and induce anagen (growth phase) in telogen (resting phase) hair follicles when binding to hair follicle cell target receptor proteins. Testing in rats and minipigs demonstrated favorable toxicology and toxicokinetic profiles. Phase 1 clinical testing showed it to have a favorable safety profile and to be well-tolerated. The response of hair growth observed in Phase 2 AGA clinical testing together with a continued favorable safety profile with longer treatment anchors further development. About Androgenetic Alopecia (AGA) Androgenetic Alopecia (AGA), also called male or female pattern baldness, is the most common hair loss condition affecting both men and women, with a higher incidence in men. While more than half of adult males suffer from AGA, this rate increases to 80% in men at age 50 and above. Male AGA is characterized by receding hairline and baldness on the top and front of the head. Female AGA is usually manifested as hair density thinning on the top and crown of the head. As a degenerative disorder with etiology largely unknown, genetic, psychological and mental, endocrinologic and metabolic factors may play a role. The pathogenesis underlying AGA has been linked to hyperactivation of androgen receptors in hair follicle cells, rendering resting hair follicles unable to re-enter the growth phase and undergoing miniaturization. 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 has now successfully completed Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has recently completed Phase 1 clinical testing with a favorable safety profile. The pipeline targets dermatologic indications. INVESTOR AND MEDIA CONTACT Technoderma Medicines, Inc. Zengquan Wang, PhD, CEO [email protected] SOURCE Technoderma Medicines

Phase 2Phase 1Clinical Result

100 Deals associated with TDM-105795

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Androgenetic Alopecia	Phase 2	United States	Technoderma Medicines, Inc.	06 Mar 2023
Alopecia	Phase 2	United States	Technoderma Medicines, Inc.	-

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05802173 (CTgov)	Phase 2	Androgenetic Alopecia	71	TDM-105795, 0.0025% (TDM-105795 Topical Solution, 0.0025%)	jfqdbrxaik(jtspjzmwjq) = bitethaxtt omltgmkklh (ejlrgxcuwc, 29.40) View more	-	12 Nov 2025
				TDM-105795, 0.02% (TDM-105795 Topical Solution, 0.02%)	jfqdbrxaik(jtspjzmwjq) = fjojaeoeue omltgmkklh (ejlrgxcuwc, 18.59) View more
NCT05802173 (PRNewswire) Manual	Phase 2	Androgenetic Alopecia	71	TDM-105795 0.02%	bpqalybeyc(vgqalzdmbu) = uqydszrcqv pzrzjufxxz (nssdxpbzqj )	Positive	05 Feb 2024
				TDM-105795 0.0025%	bpqalybeyc(vgqalzdmbu) = xdiafbppiv pzrzjufxxz (nssdxpbzqj )

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