Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 431

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1B
Chunk 431
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focus is to selectively target the sodium ion-channel known as “NaV1.7”, which has been genetically validated as a
pain receptor in human physiology. A NaV1.7 blocker is a chemical entity that modulates the structure of the sodium-channel in
a way to prevent the transmission of pain perception to the CNS. Our goal is to develop a novel and proprietary class of NaV blockers
that target the body’s peripheral nervous system.

68 

We
have formally launched three programs developing pain treatment therapeutics, all of which are based on the same proprietary molecule,
as follows:

Eye
Pain: Based on a novel formulation of CC8464, our 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. We intend 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. We have developed topical ophthalmic
formulations and are pursuing trial plans as set forth below.

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, we estimate 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,

    ●