CLINICAL STUDIES

Kamari Pharma is well positioned to treat extremely debilitating rare dermatology diseases and itch. We develop effective disease modifying treatments for patients with great unmet needs.

PROFESSIONALS

Palmoplantar Keratodermas

The Palmoplantar Keratodermas (PPKs), are a group of rare skin conditions that result from various mutations in several epidermal genes.

Lichen Simplex Chronicus

A topical cream is developed for the relief of itch associated with Lichen simplex chronicus (LSC).
Lichen simplex chronicus (LSC) is a chronic pruritic condition.

Palmoplantar Keratodermas

The Palmoplantar Keratodermas (PPKs), are a group of rare skin conditions that result from various mutations in several epidermal genes. Mild to moderate PPK’s are characterized by thickening of the skin on the palms and soles leading to great discomfort, itch and pain. The PPKs include diseases such as Punctuate PPK type 1 (PPPK1), Pachyonychia Congenita (PC) and Mal de Meleda, all of which have significant unmet medical need.
KM-001 is a novel pharmaceutical topical cream for the treatment of PPPK1 and PC. The Active ingredient is a TRPV3 inhibitor. The TRPV3 ion channel is abundant in the skin’s Keratinocytes and coupled to EGFR. Thus, it may be involved in the mechanism leading to keratodermas development which consist of EGFR excessive activation, like PPPK1 and PC (Wang and Chang 2003; Chen, Wang, and Chang 2007)

Kamari pharma is currently enrolling patients for clinical study in PC
and PPPK type-1

These are open label clinical studies to assess the safety and efficacy of KM-001 topical cream in 1% strength, in PPPK1 and PC patients. These Phase 1b studies are a Proof-of-concept studies, to evaluate the effectiveness of KM-001 in the treatment of PC and PPPK1 of adult patients.
The studies are enrolling patients currently in Israel and UK.
See additional details and contact in:
Israel – NCT05435638
UK – NCT05956314

Lichen Simplex Chronicus

A topical cream is developed for the relief of itch associated with Lichen simplex chronicus (LSC).
Lichen simplex chronicus (LSC) is a chronic pruritic condition characterized by areas of thickened skin resulting from repeated rubbing or scratching. It may present with associated dryness, scaling, or redness (erythema). Commonly affected areas include the neck, ankles, extremities, scalp, and genital region. Currently, there is no effective therapy for LSC related itch, which negatively impacts the quality of life for approximately 12% of the adult population.

The solution

KM-001 is a novel pharmaceutical topical cream in development for the treatment of LCS related itch. The cream’s active ingredient is a TRPV3 inhibitor- The TRPV3 ion channel is abundant in Keratinocytes, which was demonstrated to be involved the molecular cycle leading to inflammation and itch (Nilius, Bíró, and Owsianik 2014; Xiao et al. 2008 )

Kamari pharmahas completed the clinical study in Lichen Simplex Chronicus in Germany

This was a double blind, vehicle controlled , randomized clinical study to assess the safety and efficacy of KM-001 topical cream in 0.3% and 1% strength, in Lichen Simplex Chronicus patients.
The primary objective was to assess the safety and tolerability of the Km-001 in adults patients with moderate to sever pruritus associated LSC.
The Secondary objective was to assess the efficacy of KM-001 (0.3% and 1%) in reducing pruritis (change from baseline to week 4 in PP-NRS scale) and in treatment of LSC target lesion (change from baseline to week 4 in IGA score scale). Results will be presented soon.