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ACT01 + Comp03
- Development stage
- Discontinued
- Lead developer
- Promius Pharma, LLC
- Modality
- Small Molecules
- Administration
- Topical
01
Overview
ACT01 + Comp03 is an investigational combination therapy developed by Almirall for the treatment of actinic keratosis (AK). The combination consists of ACT01, a novel small molecule Src kinase inhibitor, and Comp03, which has been identified in related Almirall clinical trials as diclofenac sodium (a nonsteroidal anti-inflammatory drug). The therapy was designed for topical application to treat non-hypertrophic and non-hyperkeratotic actinic keratosis lesions on the face or scalp. The combination aimed to leverage the anti-proliferative effects of Src inhibition—which disrupts oncogenic signaling and tubulin polymerization in precancerous keratinocytes—alongside the anti-inflammatory and pro-apoptotic effects of diclofenac. A Phase 1 clinical trial (NCT05496361) was conducted to evaluate the safety, tolerability, and efficacy of the combination; however, the ACT01 program was subsequently removed from Almirall's active development pipeline as of 2024.
- Other names
- ACT01 + diclofenac
02
Targets
PGHS-1 (Prostaglandin G/H Synthase 1)PTGS2 (Prostaglandin-Endoperoxide Synthase 2)SRC (Proto-oncogene tyrosine-protein kinase Src)
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