Pezadeftide
A potentially safe, effective, convenient and consumer-friendly treatment for onychomycosis.Pezadeftide in action
Pezadeftide is the first in a new class of antifungal agents. Its unique and powerful antifungal activity and ability to penetrate the human nail rapidly mean it has the potential to be more effective than existing topical therapies with a shorter treatment duration and without the potentially harmful effects associated with oral medications.
Watch this brief animation to learn more about how pezadeftide works.
Short course of therapy
Dramatically shorter course of therapy than existing topical treatment alternatives
Better efficacy
Clearing fungus from the nail two-times more effectively than current best-in-class products at the same time point
Fast acting
Improvement in the appearance of the infected nail is evident in as little as 2 weeks
Safe and well tolerated
With no treatment area irritation or treatment-related adverse events
Locally acting
Penetrating nails to target the site of infection but not detectable in the blood stream
Why might pezadeftide be better than current treatments?
Hexima has demonstrated that pezadeftide penetrates the nail more effectively than existing topical treatments and so can more readily target the fungal cells which proliferate in the nail bed. It is also more effective at rapidly killing fungal cells on contact. Together, these properties mean that pezadeftide has the potential to resolve the fungal infection more quickly, leading to faster and more complete clearing of the infected nail area.
In a phase I dose-escalation study of pezadeftide applied topically to patients with mild to moderate onychomycosis, pezadeftide was safe and well-tolerated and reduced the area of infection with a much shorter treatment period than current best-in-class therapies.
In the largest cohort, following 6 weeks of daily treatment, pezadeftide’s Mycological Cure* rate measured 12 weeks after the start of treatment was >2-fold higher than current treatments at the same time point.
* Mycological Cure = no fungus in samples collected from underneath the nail as assessed by stain (microscopy) and culture (growth).
Rapid resolution of disease
Six weeks daily application of pezadeftide demonstrated rapid improvement in the appearance of the infection over 12 weeks.
Phase II clinical trial
Hexima is currently conducting an Australian phase II clinical trial testing pezadeftide as a treatment for onychomycosis.
This phase II clinical trial is a multi-centre trial being conducted across 14 clinical sites in Australia and New Zealand. Subjects with onychomycosis are randomly assigned to one of three treatment arms i) 12 weeks; versus ii) 31 weeks of daily therapy; versus iii) 12 weeks of daily therapy followed by once a week therapy out to 36 weeks.
The study is vehicle-controlled, where 25% of subjects will receive the vehicle (formulation with no pezadeftide in it). Both the patient and the evaluating professional are blinded to the active/vehicle identity.
By comparing the results in each arm of this trial we intend to identify the optimum dosing regimen to take into Hexima’s US phase III clinical trial program.
A consumer-centric product solution
In preparation for phase III studies, Hexima is developing a consumer-friendly packaging solution and companion mobile application to enhace the patient user experience and improve compliance.
CompliancePak
✓No spill / difficult to misplace
✓Easy to open and use
✓Reinforces FDA use directions
✓Connects by QR code to mobile app
Mobile app
✓Reinforces FDA use directions (with video)
✓Compliance reminders / confirmation of treatment
✓Visual tracking of treatment progress
✓Teledoc: diagnosis, prescription and refills
Learn more about onychomycosis and the need for a safe, convenient and more effective topical product
References
a.Internal Hexima research; b. Kaken Pharma and Dow Pharma, Sugiura et al., 2014; c. UCSF Medical Center, Hui et al., 2006; d. HXP124-ONY-001 clinical study report (ACTRN12618000131257);