# US 2025/0375495 A1 · Topical croton lechleri compositions and their use in the treatment of a bacterial colonization or primary or secondary bacterial infection of an underlying skin disorder

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- Number: US 2025/0375495 A1
- Document ID: US20250375495A1
- Status: Published application
- Kind: A1
- Application number: 19/301,088
- Filed: 2025-08-15
- Published: 2025-12-11
- Earliest claimed: 2020-09-22
- Assignees: Alphyn Biologics, Inc.
- Applicants: Alphyn Biologics, Inc.
- Inventors: Gary Michael PEKOE; Jazmyne Kristyne MINK; Steven Aaron PENTELNIK; Neal G. KOLLER
- Web page: https://patentgrep.com/patent/US20250375495A1

## CPC

- A61K 36/47: Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
- A61K 31/343: condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61P 31/04: Antibacterial agents
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present disclosure provides for a method of treating a bacterial colonization or primary or secondary bacterial infection of an underlying skin disorder in a subject via the topical administration of a pharmaceutical composition comprising a therapeutically effective amount of an extract of the Croton lechleri tree. Additionally the present disclosure provides for a method of treating a bacterial colonization or primary or secondary bacterial infection of the nasal mucosa in a subject via the nasal administration of a pharmaceutical composition comprising a therapeutically effective amount of an extract of the Croton lechleri tree. Also provided are details of studies on the effectiveness of an extract of the Croton lechleri tree on bacterial pathogens.

## Claims

### Claim 1

A method of treating atopic dermatitis in a subject in need thereof comprising topically administering to affected areas of the subject a pharmaceutical composition containing a therapeutically effective amount of filtered latex of Croton lechleri, wherein the therapeutically effective amount of filtered latex of Croton lechleri is about 10 wt % to about 60 wt %, and wherein the atopic dermatitis is treated.

### Claim 2 (depends on 1)

The method of claim 1, wherein the atopic dermatitis is mild to moderate.

### Claim 3 (depends on 1)

The method of claim 1, wherein the Croton lechleri is Croton lechleri Müll. Arg.

### Claim 4 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of filtered latex of Croton lechleri is about 40 wt %.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject is age 2 years or older.

### Claim 6 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition further comprises a pharmaceutically acceptable carrier.

### Claim 7 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is a hydrogel.

### Claim 8 (depends on 1)

The method of claim 1, wherein the topical administration results in no drug adverse effects upon application.

### Claim 9 (depends on 1)

The method of claim 1, wherein the atopic dermatitis is accompanied by bacterial colonization or primary or secondary bacterial infection is selected from the group consisting of Staphylococcus aureus colonization, methicillin-resistant Staphylococcus aureus (MRSA) colonization, Coagulase-negative Staphylococcus colonization, Staphylococcus aureus infection, methicillin-resistant Staphylococcus aureus (MRSA) infection, Coagulase-negative Staphylococcus infection, and combinations thereof.

### Claim 10 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is a Staphylococcus aureus colonization.

### Claim 11 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is a methicillin-resistant Staphylococcus aureus (MRSA) colonization.

### Claim 12 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is a Coagulase-negative Staphylococcus colonization.

### Claim 13 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is a Staphylococcus aureus infection.

### Claim 14 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is a methicillin-resistant Staphylococcus aureus (MRSA) infection.

### Claim 15 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is a Coagulase-negative Staphylococcus infection.

### Claim 16 (depends on 9)

The method of claim 9, wherein the bacterial colonization or primary or secondary bacterial infection is treated.

### Claim 17 (depends on 1)

The method of claim 1, wherein the treatment comprises an outcome selected from a decrease in IGA score by at least 1 point, a decrease in EASI by at least 20%, an improvement in Peak Pruritus NRS score, an improvement in the SIRS score by at least 1, a reduction in percent BSA, an improvement on one or more symptoms assessed by POEM, and a combination thereof.

### Claim 18

A method of treating atopic dermatitis accompanied by bacterial colonization or primary or secondary bacterial infection in a subject in need thereof comprising topically administering to affected areas of the subject a pharmaceutical composition containing a therapeutically effective amount of filtered latex of Croton lechleri, wherein the therapeutically effective amount of filtered latex of Croton lechleri is about 10 wt % to about 60 wt %, and wherein the atopic dermatitis is treated.

### Claim 19 (depends on 18)

The method of claim 18, wherein the therapeutically effective amount of filtered latex of Croton lechleri is about 40 wt %.

### Claim 20 (depends on 18)

The method of claim 18, wherein the bacterial colonization or primary or secondary bacterial infection is selected from the group consisting of Staphylococcus aureus colonization, methicillin-resistant Staphylococcus aureus (MRSA) colonization, Coagulase-negative Staphylococcus colonization, Staphylococcus aureus infection, methicillin-resistant Staphylococcus aureus (MRSA) infection, Coagulase-negative Staphylococcus infection, and combinations thereof.

### Claim 21 (depends on 18)

The method of claim 18, wherein the treatment comprises an outcome selected from a decrease in IGA score by at least 1 point, a decrease in EASI by at least 20%, an improvement in Peak Pruritus NRS score, an improvement in the SIRS score by at least 1, a reduction in percent BSA, an improvement on one or more symptoms assessed by POEM, and a combination thereof.

### Claim 22 (depends on 18)

The method of claim 18, wherein the bacterial colonization or primary or secondary bacterial infection is treated.