Policy & Regulation
DermBiont Touts Positive Data from a Phase 2 Trial Treating Solar Lentigos and Normalizing Pigmentation of the Skin with 0.8% SM-030 Topical Gel
31 May 2023 - - US-based clinical-stage biotechnology company DermBiont has released positive data from its Phase 2 trial with 0.8% SM-030 gel, a product under development capable of regulating pigmentation by controlling the formation of new melanin, the company said.

Disorders of hyperpigmentation, such as melasma, photoinduced hyperpigmentation, and solar lentigos (lentigines), are common skin conditions affecting between 5% and 30% of the general population and are caused by an over production or irregular dispersion of epidermal melanin.

There is no existing product that effectively and safely specifically inhibits the production of excess epidermal melanin.

Tyrosinase, the key enzyme in the melanin synthetic pathway, requires phosphorylation by PKCβ for activity. SM-030 is a first-in-class selective and potent topical PKCβ inhibitor designed to inhibit PKCβ to reduce the production of excess epidermal melanin.

DermBiont's Phase 2 trial with SM-030 was conducted with two different groups of subjects.

The first treatment group was an open-label within-subject bilateral-comparison group in 15 subjects with at least four solar lentigos on each dorsal hand treated twice-daily on one dorsal hand for 12 weeks with 0.8% SM-030 gel.

The contralateral hand was untreated. The second group treated consisted of a group of 60 healthy volunteer subjects with Fitzpatrick Skin Type IV or V who were randomized 1: 1: 1 to receive either 0.8% SM-030 gel, vehicle gel, or 4% hydroquinone cream (an active comparator) applied to the dorsum of the hand (sun exposed skin) and upper inner arm (sun protected skin) with the contralateral hand and arm serving as untreated controls. Evaluations were observer blinded.

Subjects in both groups (solar lentigos subjects and normal healthy volunteers) were assessed by way of the Investigator Dynamic Global Assessment Score at week 12. The IDGA score is a numerical score based on physician scoring of the pigmentation in the area of test article application relative to the untreated control site.

The IDGA score ranges from -3 to +3 defined as markedly less pigmentation than the untreated control site (IDGA = -3); moderately less pigmentation than the untreated control site (IDGA = -2); slightly less pigmentation than the untreated control site (IDGA = -1); similar pigmentation to the untreated control site (IDGA=0); slightly more pigmentation than the untreated control site (IDGA = 1); moderately more pigmentation than the untreated control site (IDGA = 2); or markedly more pigmentation than the untreated control site (IDGA = 3).
The Melanin index measured by colorimeter, defined by L and ITA (degrees) calculations was also evaluated at each visit using a non-invasive biophysical measurement with a colorimeter (Chromometer CM-700: Konica-Minolta, Osaka, Japan).

Solar Lentigos Open Label Subjects: on the dorsal hand with the treated lentigos, 100% of subjects achieved either an IDGA of –2 (moderately less pigment) or –1 (slightly less pigment) with 27% achieving an IDGA of –2.

There was also a statistically significant difference between the change in colorimetry from screening readings (p