Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 685

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 2
Chunk 685
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 its characteristics, preclinical studies (described below) and
the Phase 1 studies we have completed to date, we believe that CC8464, if approved, could become an attractive option for both
patients and physicians as a treatment for moderate-to-severe pain in Erythromelalgia (“EM”) and idiopathic
small fiber neuropathy (“iSFN”).

70 

We
conducted four Phase 1 trials with 207 patients. The results showed that CC8464 has a good overall tolerability and demonstrated
no liver or renal toxicity, no central nervous system changes and no cardiovascular findings but may cause skin rashes in certain
patients. The occurrence of skin rashes is not uncommon with the class of molecules to which CC8464 belongs and the rashes were
successfully treated in all cases with topical steroids and/or topical antihistamines (with the exception of one patient requiring
systemic steroids).

As
a result of the potential for skin rashes, following discussions with the FDA, we will conduct a slow dose escalation study
to further evaluate the incidence of rashes. By titrating the dose over several weeks, we anticipate that we will reduce or eliminate
this side effect. We expect that the slow dose escalation study will also help determine the need for dose escalation in the final
treatment regime. Even though the FDA has in the past approved drugs that listed rashes as a potential side effect, we do not
know if CC8464 will be approved by the FDA (or any foreign authority).

When
the dose escalation trial is funded, we will enroll approximately 20 healthy volunteers who will receive CC8464 over a period
of several weeks, with the dose escalation study expected to take approximately 9-12 months in total. We anticipate that the slower
dose escalation will decrease the likelihood of drug-related skin reactions. The primary endpoint of the dose escalation trail
will be safety and tolerability of the slower dose titration; however, we will also be measuring blood concentrations of CC8464,
which will allow us to better understand the pharmacokinetics of CC8464. Even if it is ultimately determined that we will need
an escalation period for chronic pain treatment therapy, which patients could well take for the remainder of their lives, we do
not believe the dose escalation approach will be consequential.

We
plan to conduct the dose escalation trial in Australia to avail ourselves of the tax credit set forth above, utilizing our Australian
subsidiary