Pezadeftide
A potential safe, effective, convenient and consumer-friendly treatment for onychomycosis.Pezadeftide in Action
Historically, therapies for onychomycosis have generally focused on new forms of the azole class of antifungal agents or improving the topical delivery of systemic antifungal agents. Hexima’s technology is a completely novel approach with fundamental differences that address the well-documented limitations of these traditional technologies.
Pezadeftide in Action
How is Pezadeftide better than other treatments?
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. Consequently, pezadeftide offers the promise to capture significant value in a large and poorly served market.
In a phase 1/2a dose-escalation study of pezadeftide applied topically to patients with mild to moderate onychomycosis pezadeftide was safe and well-tolerated and substantially reduced the area of infection with a much shorter treatment period than current best-in-class therapies.
Following 6 weeks of daily application, 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.
Pezadeftide produced rapid clearing of infected nails with just 6 weeks of daily treatment
Images from HXP124-ONY-001 clinical trial
* Mycological Cure = no fungus in samples collected from underneath the nail as assessed by stain (microscopy) and culture (growth).
References
1.Tatchibana et al., Journal of Fungi, 2017; 2.Persistence Market Research 2018; 3.ClearView Healthcare Partners proprietary market research, 2019; 4.Joseph et al, Supplement to Podiatry Today, 2013; 5. Milobratovic et al., Mycoses, 2013; 6. Internal Hexima research; 7. Kaken Pharma and Dow Pharma, Sugiura et al., 2014; 8. UCSF Medical Center, Hui et al., 2006; 9. HXP124 PI/IIa clinical trial, HXP124-ONY-001 (ACTRN12618000131257); 10. Efinaconazole FDA and PMDA reviews; 11. Evans & Sigurgeirsso, BMJ, 1999;
Advantages of Pezadeftide
Hexima believes pezadeftide addresses the important short comings of available treatments for onychomycosis. It is a broad spectrum and powerful antifungal agent which penetrates nails very rapidly when applied topically. This is a consumer driven market and based on our market research, there is a well-defined and under-served demand from consumers (clinicians and their patients) who are looking for such features in their treatment.
Short course of therapy
Pezadeftide appears active following just 6-weeks of daily therapy
Better efficacy
Clearing fungus from the nail two-times more effectively than current best-in-class (more than oral and topical) products at the same time point
Fast acting
Dramatically improving the appearance of the infected nail in less than 12 weeks
Safe and well tolerated
With no treatment area irritation or treatment-related adverse events
Locally acting
Pezadeftide effectively penetrates nails but is not detected in the blood stream and has not presented any systemic toxicity
Phase IIb Clinical Trial
Hexima is conducting a phase IIb clinical trial of its lead antifungal molecule, pezadeftide (previously HXP124), as a potential topical treatment for fungal nail infections (onychomycosis). Hexima’s goal is to develop a safe and effective prescription topical treatment for onychomycosis, with a convenient short course of therapy delivering rapid clearance of infection.
A consumer centric solution
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CompliancePak
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✓No spill / difficult to misplace
✓Easy to open / child resistant
✓Reinforces FDA use directions
✓Connects by QR code to mobile app
Mobile app
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✓Reinforces FDA use directions (with video)
✓Compliance reminders / confirmation of treatment
✓Visual tracking of treatment progress
✓Teledoc: diagnosis, prescription and refills
