Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 69

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 69
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with the results summarized in the following graph: 

Trial Two 

In the second trial, benzalkonium chloride
(“BAC”) was instilled in mice eyes over a multiday period to create a model of dry eye disease (the study was repeated
twice). BAC is a detergent that irritates the eyes and simulates dry eye disease. As with the capsaicin model summarized above,
increased paw wipes over 60 seconds are a surrogate to measure ocular pain. Following the induction of dry eye using BAC, the
mice were dosed with CT2000 four times per day for 7 days. CT2000 reduced the frequency of paw wipes within a single day of administration
and showed cumulative efficacy over time (the analgesic effect appeared to further improve when dosed over several days). The
results after 1 day of dosing CT2000 are summarized in the following graph: 

Following
the animal studies, if successful, Channel intends to move into proof-of-concept (“POC”) studies in humans. Channel
plans to conduct the POC study in Australia to avail itself of the streamlined regulatory structure and a 43.5% tax credit for
clinical expenses incurred in Australia and, on January 9, 2023, established an Australian subsidiary through which the work will
be conducted. Channel is planning to conduct the POC in a clinic in Brisbane, Australia and are is in the process of contracting
the services to perform a trial in patients suffering from pain associated with dry-eye disease.

Depot
Program: Based on several novel formulations of CC8464, Channel’s most recently launched program, titled CT3000, is
for the potential treatment of post operative pain with the use of nerve blocks.  Examples would include knee surgery or
shoulder surgery. Existing therapies for nerve blocks lead to neuromuscular blockade which prevents movement following surgery.
Doctors often want patients to move soon after surgery to avoid complications such as blood clots. A NaV1.7 inhibitor used for
nerve blocks may provide good analgesia but will not lead to neuromuscular blockade that prevents movement like other local anesthetics.

Channel
has successfully developed a number of formulations and in December 2024, announced that it achieved its endpoints in two pre-clinical
in vivo models of Channel’s nerve block formulations for acute pain, showing material improvement over the existing standard
of care, bupivacaine,