TDM-180935 / TechnoDerma Medicines - LARVOL DELTA

Study of TDM-180935 in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: Technoderma Medicines Inc. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Technoderma Medicines Completes Positive Ph2a Proof- of Concept Trial with Topical TDM-180935 Ointment for Atopic Dermatitis (PRNewswire) - P2a | N=24 | NCT06363461 | Sponsor: Technoderma Medicines Inc. | "Technoderma Medicines, Inc...is pleased to report the Company has completed its Phase 2a clinical trial (NCT06363461) of topical TDM-180935 ointment in patients with Atopic Dermatitis (AD)...The primary efficacy endpoint scored for change from baseline in m-EASI at week 8 and was met in the high strength 2% TDM-180935 randomized cohort and further supported by positive responses in the corresponding open-label cohort. Substantial m-EASI-75 and m-EASI-90 reponses were clearly achieved in all active treatment groups. In addition, the registration efficacy endpoint of proportion of patients with vIGA-AD score of 0 to 1 with ≥ 2 point improvement from baseline demonstrated a positive dose response of 12.5%, 37.5%, and 62.5% for pooled placebo, 1% TDM-180935, and 2% TDM-180935, respectively."

P2a data • Atopic Dermatitis

Study of TDM-180935 in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Technoderma Medicines Inc. | Trial completion date: Oct 2024 ➔ May 2025 | Trial primary completion date: Sep 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of TDM-180935 in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Technoderma Medicines Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of TDM-180935 in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Technoderma Medicines Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Technoderma Medicines Advances TDM-180935 Atopic Dermatitis Clinical Program with Phase 2 Trial (PRNewswire) - "Technoderma Medicines...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....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."

Trial status • Atopic Dermatitis

Study of TDM-180935 in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Technoderma Medicines Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Technoderma Medicines Completes Phase 1 Dose Escalation Clinical Trial of TDM-180935 for Atopic Dermatitis (PRNewswire) - "Technoderma Medicines...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'....All strengths of TDM-180935 (0.25%-2.0%) were well tolerated with no material safety issues identified....'This is a major milestone for the Company as we can now transition our second clinical program into Phase 2.'"

Trial completion • Atopic Dermatitis

A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Technoderma Medicines Inc. | Recruiting ➔ Completed

Trial completion

A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Technoderma Medicines Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Feb 2023

Enrollment open • Trial initiation date

Technoderma Medicines Initiates TDM-180935 Atopic Dermatitis Clinical Program with Phase 1 Dose Escalation Trial (PRNewswire) - "Technoderma Medicines, Inc...is pleased to report the Company has begun dosing healthy volunteer subjects in its Phase 1 clinical trial of topical TDM-180935 ointment. This first clinical trial in the Atopic Dermatitis (AD) program includes single dose and multidose escalation cohorts in a study....Study objectives are to evaluate the safety and pharmacokinetics of topical TDM-180935. One U.S. clinical site is currently participating in this study under an open IND with FDA."

Trial status • Atopic Dermatitis • Dermatology • Immunology

A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Technoderma Medicines Inc.

New P1 trial