Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 71

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 71
---
 both patients and physicians as a treatment for moderate-to-severe pain in Erythromelalgia (“EM”) and idiopathic
small fiber neuropathy (“iSFN”).

Channel
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).

25

As
a result of the potential for skin rashes, following discussions with the FDA, Channel will conduct a slow dose escalation
study to further evaluate the incidence of rashes. By titrating the dose over several weeks, Channel anticipates that Channel
will reduce or eliminate this side effect. Channel 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, Channel does not know if CC8464 will be approved by the FDA (or any foreign authority).

When
the dose escalation trial is funded, Channel 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. Channel 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, Channel 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 Channel
will need an escalation period for chronic pain treatment therapy, which patients could well take for the remainder of their lives,
Channel does not believe the dose escalation approach will be consequential.

When
and if Channel decides to move forward with the CC8464, Channel expects to conduct the dose escalation trial in Australia to avail
itself of the streamlined regulatory structure and tax credit set forth above, utilizing its Australian subsidiary through which
the work will be conducted. The location of the POC has not been determined at this time, with