Pillar Four

Dermatology

Two clinically de-risked topical assets, both with positive human data.

Pipeline

Candidate
Preclinical
Phase I
Phase II
Phase III
FDA Review
Marketed
Status
OKG-0501HPV genital wartsTopical cream
Through Phase II
OKG-0502HSV lesionsTopical cream
Through Phase I
Rows are ordered most advanced first.

Overview

Antivirals that target the infection, not the lesion

Human clinical data has been generated for both dermatology candidates. Current treatments for genital warts focus on removing the superficial external lesion rather than targeting the underlying viral infection, are surgical, topical or immune-modulating, and all destroy tissue.

There are no approved antiviral therapies for external genital warts, and average recurrence rates range from 30 to 70% within the first six months.

Skin closeup

Results

OKG-0501 — HPV Genital Warts

Positive Phase IIa — OKG-0501, topical cream

EndpointPlaceboActivep-value
Week 8 mean % lesion area loss (ITT)31%71%0.0007
Week 8 mean % lesion area loss (PP)31%72%0.0012
Loss of 80% or greater lesion area (ITT)34%60%0.0253
100% clearance, FDA-recommended endpoint (ITT)13.2%37.8%0.013
100% clearance, FDA-recommended endpoint (PP)14.3%41.2%0.012
The Phase IIa met both its primary and secondary endpoints, and showed a statistically significant effect on the endpoint the FDA recommends for Phase 3 trials in external genital warts.

Results

OKG-0502 — HSV Lesions

Positive Phase IIa — OKG-0501, topical cream

2.3 Days

To clinical healing, the disappearance of blisters, after starting treatment.

39.7% Faster

Than the roughly seven-day natural course of the disease without treatment.

Partnerships

Both assets are available for licensing or non-dilutive funding.