Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 36

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 36
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 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 availability of facilities
and patient population, costs, tax credits, centers of excellence in the respective fields (EM or iSFN) are all factors in the
ultimate determination of the location.

In
parallel with the dose escalation study, Channel expects to run a pilot efficacy study on approximately ten EM patients. In this
study, Channel will induce EM flares, determine baseline pain, and then dose escalate CC8464, after which, Channel will attempt
to induce flares. The primary endpoint will be the amount of pain experienced, and the secondary endpoint is a determination if
CC8464 reduces the frequency of EM flares.

Channel
is currently working on the development of the Phase 2a POC plan and expect to launch the Phase 2a POC study following the dose
escalation study and EM pilot study, to assess the potential efficacy of CC8464 in iSFN patients. Both of iSFN and EM are orphan
indications for which Channel plans to apply for orphan drug designations. The orphan indication may decrease the scope of the
ultimate development program that is necessary for approval and is associated with a marketing exclusivity period from the FDA
along with some tax advantages.

Though
the Phase 2a POC study design has not yet been completed, the study will take approximately twelve months after it is initiated.
The primary endpoint will be the amount of pain experienced from iSFN with secondary endpoints including other measurements like
pain relief and neuropathy scores. The final design may change based on feedback from regulatory authorities or information learned
during the dose