Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 684

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 2
Chunk 684
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, announced that it achieved its endpoints in
two pre-clinical in vivo models of the Company’s nerve block formulations for acute pain, showing material improvement over
the existing standard of care, bupivacaine, in both efficacy and duration.

The
Company performed a thermal hyperalgesia test in rodents with a placebo arm, bupivacaine arm and four arms of the main formulations
of the Company’s molecule. The Company also performed a mechanical allodynia test in rodents with the same arms as above.
For both models, the drugs were administered as a sciatic nerve block. All four Company formulations showed a depot effect in
excess of four days, an improvement over bupivacaine, the current standard of care.

69 

The
results of the thermal hyperalgesia results are shown in the chart below. After thirty minutes, three of the four formulations
showed materially better efficacy than bupivacaine, with each of the three being statistically superior to placebo for more than
two days longer than bupivacaine. One of the formulations remained statistically superior to placebo for more than four days.
Further, as NaV1.7 does not have an impact on mobility, this approach may offer a better option for post-surgical physical therapy
as current nerve block therapies cause temporary paralysis in the affected area.

Similarly
for the mechanical allodynia test results, three of the four formulations showed statistically better efficacy for a longer duration
of time than bupivacaine. The mechanical allodynia test is shorter in duration, reflecting the subject’s innate swift recovery
rate to surgical incisions. Nonetheless, the results mirrored the successful results set forth with the thermal hyperalgesia test.

The
Company will commence toxicology and CMC work in 2025 and expects to commence human POC trial in early 2026. 

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