Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 35

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 35
---
 timing and budget related to the commencement of toxicology and CMC work and
a subsequent human POC trial. 

Neuropathic
Pain: CC8464 is being developed to address certain types of neuropathic pain. The chemical characteristics of CC8464 restrict
its entry into the CNS and limit its effect to the NaV1.7 channels in the peripheral nervous system, which consists of the nerves
outside the brain and spinal cord. Activation of other channels in the CNS can result in side effects, including addiction and
other centrally mediated adverse effects. 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 Channel has completed to date, Channel 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”).

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