Based on positive results from this initial Phase 2 trial with 0.8% SM-030 gel, DermBiont plans to commence a 140 subject double-blind placebo-controlled trial treating melasma with 0.8% SM-030 topical gel in the second half of 2023.

DermBiont’s 0.8% SM-030 gel performed well in a Phase 2 trial treating solar lentigos and normalizing pigmentation of the skin, the Company reports.

SM-030 is a first-in-class selective and potent topical PKCβ inhibitor intended to reduce the production of epidermal melanin. PKCβ has the ability to increase melanin production by phosphorylating and increasing the activity of tyrosinase, which is the key and final enzyme in the melanin synthetic pathway.

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 (BID) 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 (IDGA) Score at week 12. 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.

Solar Lentigos Open Label Subjects: 

On the dorsal hand with the treated lentigos, 100% of subjects (n=15) achieved either an IDGA of –2 (moderately less pigment) or –1 (slightly less pigment) with 27% (n=4) achieving an IDGA of –2. There was also a statistically significant difference between the change in colorimetry from screening readings (p<0.0001) between treated and untreated lentigos at Week 12.

Healthy Volunteer Randomized Subjects: 

On the sun exposed dorsal hand, 85% of subjects treated with 0.8% SM-030 gel, 75% with 4% hydroquinone, and 35% with vehicle gel achieved an IDGA score of –1 or less (p<0.01 comparing 0.8% SM-030 vs. vehicle). 30% of subjects treated with 0.8% SM-030 gel, 20% with 4% hydroquinone, and 0% with vehicle gel achieved an IDGA score of –2 or less (p<0.05 comparing 0.8% SM-030 vs. vehicle). There were no observed changes in the sun protected upper inner arm.

All Subjects: 

The treatment was well tolerated, with 99% of safety observations having no local tolerability reactions. Any local tolerability reactions that occurred were all mild in nature, transient, and resolved without sequelae. There were no serious adverse events.

“The data seen in this Phase 2 trial of SM-030 is highly encouraging as we have demonstrated IDGA improvement as well as a clear separation from placebo from baseline to the end of treatment,” says Karl Beutner, M.D., Ph.D., CEO, and Co-Founder of DermBiont, in a news release. “The existing options for treating hyperpigmentation lack sufficient efficacy, safety, and tolerability, and we believe that the successful development of SM-030 could bridge this gap and provide patients with an alternative treatment option that is safe for long-term use and very well tolerated amongst patients.”

Based on positive results from this initial Phase 2 trial with 0.8% SM-030 gel, DermBiont plans to commence a 140 subject double-blind placebo-controlled trial treating melasma with 0.8% SM-030 topical gel in the second half of 2023.

“The results of this initial trial are particularly exciting for melasma patients who currently treat dermal melanin with lasers but do not have any option to inhibit excess production of epidermal melanin, the root cause of patients’ melasma,” says Nichola Eliovits, Co-Founder and Chief Business Officer at DermBiont. “SM-030 will efficaciously and safely inhibit excess production of epidermal melanin that leads to hyperpigmentation, resulting in monochromatic skin while providing desirable results to patients without the hypopigmentation side effects or the array of safety concerns associated with current treatments, including hydroquinone which is toxic to melanocytes and has been banned as a monotherapy at both 2% (OTC) and 4% (Rx) concentrations by the FDA.”