Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 44

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 1
Chunk 44
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 Since CC8464 is designed to not penetrate the CNS it is highly unlikely to produce CNS
mediated side effects including euphoria or addiction. Based on its characteristics, preclinical studies (described below) and
the Phase 1 studies Pelthos has completed to date, Pelthos believes 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”).

Pelthos
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, Pelthos will conduct a slow dose escalation
study to further evaluate the incidence of rashes. By titrating the dose over several weeks, Pelthos anticipates that Pelthos
will reduce or eliminate this side effect. Pelthos expects 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, Pelthos does not know if CC8464 will be approved by the FDA (or any foreign authority).

When
the dose escalation trial is funded, Pelthos 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. Pelthos anticipates 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, Pelthos will also be measuring blood concentrations
of CC8464, which will allow it to better understand the pharmacokinetics of CC8464. Even if it is ultimately determined that Pelthos
will need an escalation period for chronic pain treatment therapy, which