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For millions of onychomycosis sufferers, currently available topical treatment options

are safe yet only modestly effective, while oral medications are effective yet
associated with the risk of serious systemic side effects.
Luliconazole has several very important properties that set the molecule apart from
anything currently on the market or in development. Chief among Luliconazoles
core attributes are superior mycologic potency (approximately 3060x more potent
than any antifungal molecule approved or in development), excellent safety, and
tolerability in a cosmetically elegant, easy-to-use solution.

BEST-IN-CLASS ANTIFUNGAL
POTENCY

A new molecule among the imidazoles, Luliconazole is one of the most potent and
broad-spectrum topical prescription antifungal agents known against the
dermatophytes (Trichophyton rubrum and Trichophyton mentagrophytes) that cause
90% of onychomycosis.
Luliconazole is 30x more potent against these pathogens than the active ingredient
in Jublia (efinaconazole) 10% topical solution based on a head-to-head in

vitro study that was reported at the International Society for Human and Animal
Mycology Meeting in May of 2015.

Luliconazoles considerably greater antifungal potency for these key dermatophytes


as compared to that of antifungals currently on the market for the topical treatment
of onychomycosis supports the molecules potential to be a best-in-class treatment
for onychomycosis sufferers.

DUAL MODE OF ACTION:


FUNGICIDAL AND FUNGISTATIC
PROPERTIES
Luliconazole combines broad-spectrum fungicidal super-potency with enduring, lowMIC-level fungistatic activity that may help prevent early reinfection in the critical
post-treatment period. In addition to the drugs safety and tolerability profile, the
pharmacokinetic profile of 10% Luliconazole Solution seen in the companys phase

1 trial suggests the potential for the nail to act as a reservoir that continuously
delivers the drug to
the site of the
infection.
Luliconazole has
demonstrated
complete fungal
eradication within
only 21 days in in
vitro-infected nail
models and has
shown the ability in animal models to prevent fungal reinfection of the skin for up to 4
months post-application.
Topicas phase 2 trial has provided compelling clinical evidence that treatment with
10% Luliconazole Solution achieves complete cure at week 52 in patients with mildto-moderate distal subungual onychomycosis.
Luliconazoles exceptional antifungal potency, tolerability, and clinical trial results
show the drugs potential to be a best-in-class topical treatment for onychomycosis.

RAPID PENETRATION OF THE


NAIL WITH A SUBSTANTIAL
FLUX RATE

Due to
Luliconazoles
molecular size,
chemical structure,
and weak binding
affinity to keratin
(the main
component of the
nail), the product
has proven in in
vitro studies to readily cross the human nail plate and to penetrate the nail bed,
which is the site of fungal infection. Better still, in vitro flux rate studies (which
measure how much drug crosses the nail over time) have shown that fungicidal
levels of Luliconazole cross the nail in hours.

By contrast, many antifungal molecules tightly bind to nail keratin, inhibiting their
ability to cross the nail plate and to reach the nail bed at effective levels. Moreover,
some antifungals actually show a significant reduction of potency in the presence of
keratin.

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