KM-001 / Kamari Pharma - LARVOL DELTA

Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Kamari Pharma Ltd | Active, not recruiting ➔ Completed

Trial completion • KRT16 • KRT17 • KRT6A

Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Kamari Pharma Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2024 ➔ Sep 2024

Trial completion • Trial completion date • Trial primary completion date • KRT16 • KRT17 • KRT6A

Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Kamari Pharma Ltd | N=11 ➔ 18

Enrollment change • KRT16 • KRT17 • KRT6A

Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Kamari Pharma Ltd | Recruiting ➔ Active, not recruiting | N=19 ➔ 11

Enrollment change • Enrollment closed • KRT16 • KRT17 • KRT6A

Kamari Pharma Announces Abstracts Accepted for Presentation at the 81st Annual Meeting of the Society for Investigative Dermatology (GlobeNewswire) - "Kamari Pharma...announced two abstracts reporting results for its novel TRPV3 inhibitors, KM-001(topical) and KM-023 (oral), have been selected for presentation at the 81st Annual Meeting of the Society for Investigative Dermatology (SID), being held May 15-18, 2024 in Dallas, TX, USA.....Late breaking poster presentation includes Phase 1b clinical trial results demonstrating the safety and preliminary efficacy of KM-001, a topical TRPV3 inhibitor, for the treatment of palmoplantar keratoderma. Oral presentation highlights favorable in vitro and in vivo safety and efficacy data of novel TRPV3 inhibitors KM-001(topical) and KM-023 (oral) in preclinical 3D skin and mouse models."

Late-breaking abstract • P1 data • Preclinical • Dermatology

Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: Kamari Pharma Ltd | Phase classification: P1b ➔ P1 | N=11 ➔ 19 | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Dec 2023 ➔ Aug 2024

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • KRT16 • KRT17 • KRT6A

Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Kamari Pharma Ltd | N=10 ➔ 18 | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment change • Trial completion date • Trial primary completion date • KRT16 • KRT17 • KRT6A

KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC) (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Kamari Pharma Ltd | Recruiting ➔ Completed

Trial completion • Dermatology • Pruritus

Study Designed to Evaluate the Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Kamari Pharma Ltd | Trial completion date: Dec 2022 ➔ Dec 2023

Trial completion date • KRT16 • KRT17 • KRT6A

Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC (clinicaltrials.gov) - P1b | N=11 | Recruiting | Sponsor: Kamari Pharma Ltd

New P1 trial • KRT16 • KRT17 • KRT6A

Treatment of human palmoplantar keratoderma skin equivalents with a TRPV3antagonist, KM-001 (ISID 2023) - P1 | "Involucrin and tranglutaminase 1 expression were reduced in the PPK1 modeland restored by KM-001 (0.05 - 0.5 µM). These results suggest a beneficial effect ofTRPV3 inhibition in both PC and PPK1 which is being explored further in a phase 1Bclinical trial (NCT05435638)."

Late-breaking abstract • KRT16 • KRT6A

Evaluating the safety and efficacy of topical KM-001, a TRPV3 inhibitor, for treatment of pruritus in patients with Lichen Simplex Chronicus (LSC): A first in human, double-blind, randomized vehicle-controlled study (ISID 2023) - "A sentinel group has completed the study without any serious or treatment-emergent adverse events. Topline results are expected during Q2 2023."

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus

Novel and selective TRPV3 inhibitors as new potential treatments for keratodermas and itch (ISID 2023) - "KM-001 demonstrated a favorable topical and systemic non-mutagenic safety profile in rodents and minipigs. Several Clinical trials with topical KM-001, are ongoing in patients with keratoderma and itch and may be new promising therapies for treatment of diseases with unmet need."

Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • EGFR • FLG • IL6 • TSLP

KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC) (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Kamari Pharma Ltd

New P1 trial • Dermatology • Pruritus