Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 68

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 68
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 absorption from a topical administration would be extremely limited. Channel has developed topical ophthalmic
formulations and are pursuing trial plans as set forth below.

23

Current
options for the treatment of ocular pain center on the use of corticosteroids and non-steroidal anti-inflammatory drug (“NSAID”)
based therapeutics. These options suffer from sight-threatening complications such as Glaucoma and corneal melting, thus there
is a large unmet need for other approaches. As an example of the potential patient population, Channel estimates that there are
approximately 5 million cases of corneal abrasions per year in the United States. In addition, other potential indications associated
with eye pain include:

    ●
    severe
    dry eye,

    ●
    side
    effects from photorefractive keratectomy (PRK) and pterygium surgery,

    ●
    second
    eye cataract surgery,

    ●
    neuropathic
    corneal pain, and

    ●
    severe
    uveitis and severe iritis/scleritis.

As
NaV1.7 channels are present on the cornea and is a viable biological target for treating eye pain, Channel believes that it has
a sound scientific basis for its ability to treat a multitude of eye pain indications. It has successfully developed an eye drop
formulation and has determined that the eye drops are well tolerated by animals.

Channel has two completed animal efficacy
studies and are in the process of completing pivotal IND enabling ophthalmic toxicology studies. Channel expects to announce the
toxicology results in May 2025. The efficacy studies are as follows:

Trial One 

In the first trial, rabbits were treated
with capsaicin (i.e., Pepper spray) to mimic an acute ocular insult in a common, validated model for acute eye pain studies. Following
the capsaicin treatment, the rabbits were treated with CT2000, which was dosed four times over a 24-hour period. Pain was measured
by the number of paw wipes over 60 seconds (paw wipes are a recognized surrogate of eye pain in animal models). The results showed
that CT2000 significantly reduced the number of paw wipes within 15 minutes of administration of capsaicin and that CT2000 continued
to show efficacy over a 60-minute period following administration. This eye pain model was only validated for a short duration,