Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 32

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 32
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 on a novel formulation of CC8464, its Eye Pain program, titled CT2000, is for the potential treatment of both
acute and chronic eye pain. NaV1.7 channels are present on the cornea, making it a viable biological target for treating eye pain.
Eye pain may occur with various conditions, including severe dry eye disease, trauma and surgery. Existing therapies for eye pain
(such as steroids, topical non-steroidal anti-inflammatory agents, lubricants, local anesthetics) are limited in their effectiveness
and/or limited in the duration that they may be prescribed because of safety issues. Channel intends to explore the viability
of developing CT2000 as a topical agent for the relief of eye pain. A potential advantage of this approach is that topical administration
of CT2000 is unlikely to lead to any hypersensitivity or skin reactions, like what was noted with systemic administration of CC8464,
because the systemic 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 o