KM-023 for Olmsted Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new treatment called KM-023 for Olmsted Syndrome. The main goal is to assess the safety of KM-023 and its effects on the body, particularly changes in the skin and symptom relief. Initially, healthy individuals will take KM-023 to help researchers understand its effects. Subsequently, Olmsted Syndrome patients will receive the treatment to evaluate its efficacy for them. Individuals with Olmsted Syndrome who have specific gene mutations and noticeable skin issues on their palms and soles may be suitable candidates for the trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that KM-023 is likely to be safe for humans?
An earlier study showed promising initial safety results for KM-023. These findings suggest that KM-023 is generally well-tolerated. No major safety issues have emerged so far. Research indicates that this drug could be a promising treatment for Olmsted Syndrome, a rare skin condition. While researchers continue to collect detailed information, the early results support further research. This is encouraging for those considering participation in clinical trials for this treatment.12345
Why do researchers think this study treatment might be promising?
Olmsted Syndrome is a rare condition that currently lacks standardized treatments, often relying on symptomatic care like pain management and emollients. KM-023 is unique because it targets the underlying causes of the syndrome rather than just alleviating symptoms. Researchers are excited about KM-023 because it introduces a new mechanism of action that could potentially modify the disease course, offering hope for improved long-term outcomes. Unlike current options that focus on external symptom relief, KM-023 works internally, potentially addressing the root issues of the syndrome.
What evidence suggests that KM-023 might be an effective treatment for Olmsted Syndrome?
Research has shown that KM-023 might help treat Olmsted Syndrome. In this trial, participants with Olmsted Syndrome will receive KM-023 for 12 weeks. Studies found that doses of 10mg/kg and 20mg/kg greatly reduced the severity of keratoderma, a major symptom of this condition. This treatment blocks the TRPV3 pathway, which plays a crucial role in the disease. Previous research suggests that targeting this pathway could alleviate the skin damage and pain patients experience. KM-023 is considered a promising option for those with this rare skin disorder who have unmet treatment needs.14567
Are You a Good Fit for This Trial?
This trial is for healthy adults who don't smoke, aren't taking certain medications, have a BMI between 18 and 32, weigh between 110–220 lbs, and haven't abused alcohol or drugs. It's also for people diagnosed with Olmsted Syndrome. Participants must use contraception if needed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Healthy participants receive single doses of KM-023 to assess safety and pharmacokinetics
Multiple Ascending Dose (MAD)
Healthy participants receive repeated doses of KM-023 twice daily for 5 days
Treatment for Olmsted Syndrome Patients
Olmsted Syndrome patients take KM-023 twice daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KM-023
Trial Overview
The study tests KM-023 at different doses compared to placebo. First, it's given to healthy volunteers in single or repeated doses to check safety and how the body handles it. Then Olmsted Syndrome patients take KM-023 twice daily for up to 12 weeks to see its effects.
How Is the Trial Designed?
3
Treatment groups
Active Control
Up to 4 cohorts of 8 healthy participants
3 cohorts of 8 healthy participants.
up to 8 participants with OS, receiving KM-023 for 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orvida Pharma (formerly Kamari Pharma)
Lead Sponsor
Kamari Pharma Ltd
Lead Sponsor
Citations
Orvida Pharma (formerly Kamari Pharma) Announces ...
“TRPV3 plays a key role in the underlying disease biology, and targeting this pathway with KM-023 represents a compelling therapeutic approach.
Kamari Pharma Announces New Data Presented at the ...
Phase 1b clinical trial of KM-001 demonstrated favorable safety profile and high responder rate of 87% in patients with palmoplantar ...
0563 TRPV3 novel inhibitor KM-023 as a potential oral ...
Doses of 10mg/kg and 20mg/kg significantly reduced keratoderma severity (p < 0.05) (one of the OS symptoms), while also reduced epidermal thickness and ...
4.
trial.medpath.com
trial.medpath.com/news/kamari-pharma-secures-23-million-series-a-to-advance-first-in-class-trpv3-inhibitor-for-rare-genetic-skin-diseasesKamari Pharma Secures $23 Million Series A to Advance First ...
The company plans to initiate a Phase 1b clinical trial for Olmsted syndrome in the second half of 2025, with top-line results expected by year- ...
5.
linkedin.com
linkedin.com/posts/edel-o-toole-49038399_dermatology-rareskindisease-activity-7427006698063577088-qxb1First Patient Enrolled in KM-023 Study for TRPV3-pEDD
Olmsted syndrome (TRPV3-pEDD) is a severe, ultra-rare skin disorder ... study to assess the safety, tolerability and efficacy of KM-023.
Orvida Pharma (formerly Kamari Pharma) Announces ...
These early safety data are encouraging and support the continued evaluation of KM-023 in patients with Olmsted syndrome.” About Orvida ...
Orvida Pharma Advances Hope for Rare, Painful Skin ...
Promising early safety data for a novel drug, KM-023, brings a potential first-ever targeted treatment for the devastating Olmsted syndrome ...
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