Kamari Pharma Announces Presentations at the 82nd Annual Meeting of the Society for Investigative Dermatology and the International Pachyonychia Congenita Consortium Symposium

Preclinical results presented demonstrate KM-023 is a highly effective and selective oral TRPV3 inhibitor

KM-023 normalized cells proliferation and differentiation in 3D pachyonychia congenita skin model and significantly reduced itch behavior and normalized skin structure in DS-Nh mice, expressing TRPV3 ‘gain-of-function’ mutation

Kamari to commence Phase 1b study of KM-023 is in healthy volunteers and Olmsted syndrome patients in the second half of 2025; top-line results anticipated before year end

Encore presentation of Phase 1b clinical results for KM-001, Kamari's topical TRPV3 inhibitor, demonstrate favorable safety profile and high responder rate of 87% in patients with palmoplantar keratoderma and pachyonychia congenita

/EIN News/ -- NESS ZIONA, Israel, May 08, 2025 (GLOBE NEWSWIRE) -- Kamari Pharma, a privately-held clinical stage biotechnology company developing first and best-in-class treatments for rare and severe genetic skin diseases, today announced presentations reporting results for its novel TRPV3 inhibitors, KM-023 (oral) and KM-001 (topical), were presented at the 82nd Annual Meeting of the Society for Investigative Dermatology, taking place May 7-10, 2025 in San Diego, CA, USA, and the International Pachyonychia Congenita Consortium Symposium, taking place May 7, 2025 in San Diego, CA, USA.

TRPV3, a calcium channel primarily expressed in the skin, is a master regulator of skin homeostasis. It regulates skin differentiation and Hyperkeratosis via Ca⁺² control and is responsible for pruritus (itch) sensation, the maintenance and structure of the skin barrier and skin inflammation. Gain of function variants in TRPV3 underlie Olmsted syndrome, while its overexpression is associated with various palmoplantar keratodermas.

Below are summaries of the presentations:

Society for Investigative Dermatology

Oral and poster presentation #0563: “TRPV3 novel inhibitor KM023 as a potential oral treatment for keratodermas” presented by Liora Braiman, Ph.D., Chief Scientific Officer of Kamari Pharma.

• KM-023 significantly reduced Ca⁺² flux in Olmsted syndrome keratinocytes, as demonstrated by high throughput calcium imaging and calcium flux cellular assay in human epidermal keratinocytes (nHEK) expressing either WT hTRPV3 or G573S hTRPV3 mutated form.
• In-vitro studies demonstrated treatment with KM-023 in a 3D skin equivalent model of Pachyonychia Congenita led to improvement in the impaired skin barrier and normalization of proliferation and differentiation, as assessed by Ki-67 staining, involucrin and loricrin expression and localization.
• In vivo efficacy studies performed in DS-Nh mice, a gain-of-function TRPV3 mutation model, demonstrated KM023 significantly normalized skin and reduced pruritus morphology in a dose dependent manner.
  • Significant reductions of ~1.5 points in keratoderma severity score vs vehicle at day 21 (10mg/kg, p=0.003 and 20mg/kg, p=0.0004)
  • Significant reductions of 35% and 44% in scratching bouts vs vehicle at day 21 for 10mg/kg (p<0.001) and 20mg/kg (p<0.001), respectively .
• KM023 was found to be well tolerated, and non-genotoxic in toxicology studies in rats and minipigs

"These robust preclinical results suggest that KM023 has the potential to treatment Olmsted syndrome, pachyonychia congenita and other keratodermas," said David Aviezer, Ph.D., M.B.A., Chief Executive Officer of Kamari. "We plan to commence a Phase 1 study of KM-023 in healthy volunteers and Olmstead syndrome patients in the second half of 2025 to further evaluate the safety and efficacy of this promising product candidate."

International Pachyonychia Congenita Consortium Symposium

Oral presentation: "TRPV3 inhibitors: a novel investigational treatment of PC, Olmsted syndrome and other keratoderma patients" presented by Dr. David Aviezer.

• Presented clinical results from two sixteen-week, Phase 1b open-label studies assessing 4g/day of KM-001 1% cream applied to each foot twice daily. Twenty patients with pachyonychia congenita and six patients with punctate palmoplantar keratoderma type 1 completed the treatment period.
  • Safety: No drug-related serious adverse events were reported; most adverse events were mild and localized, resolving without intervention. Minimal systemic absorption was confirmed by low plasma levels of KM001.
  • Efficacy: High responder rate observed with over 85% of patients responded to treatment in 12 weeks; disease severity scores shift to milder scores and effect sustained or improved at 16 weeks. Additionally, pain reduction was reported by 53% of pachyonychia patients (≥10-point VAS reduction by Day 84), in addition to improvements in walking distance and other physical activities. 
• Presented favorable pre-clinical results for oral KM-023 (detailed above)

About Kamari Pharma

Kamari Pharma is a privately-held clinical stage biotechnology company developing first and best in class treatments for rare and severe genetic skin diseases. Kamari’s lead molecules, KM-001 (topical) and KM-023 (oral) are novel, highly specific and selective TRPV3 inhibitors that are initially being developed to treat palmoplantar keratodermas, Olmstead syndrome and Ichthyosis. Kamari’s management team is comprised of industry leaders highly experienced in drug discovery, dermatological pharmaceutical development and rare disease drug development.

Contact Information

Investors and Media
Marcy Nanus
Managing Partner
Trilon Advisors, LLC
mnanus@trilonadvisors.com