BOSTON--(BUSINESS WIRE)--DermBiont, a clinical-stage biotechnology company that is advancing targeted topical therapeutics for the treatment of dermatological indications, today announced 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.
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 (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 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 (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,” stated Karl Beutner, M.D., Ph.D., CEO, and Co-Founder of DermBiont. “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.
Nichola Eliovits, Co-Founder and Chief Business Officer at DermBiont, added, “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. 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.”
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. SM-030 is a first-in-class selective and potent topical PKCβ inhibitor intended to reduce the production of epidermal melanin.
DermBiont’s mission is to become the world’s leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent diseases. The company aims to impact the root causes of skin diseases through the development of targeted small molecule therapeutics with well-defined mechanisms of action and biotherapeutics that repair an imbalance of the microbiome. The company’s targeted topical therapeutics pipeline includes two lead assets: SM-020 for the treatment of seborrheic keratosis and SM-030 for the treatment of hyperpigmentation disorders of the skin. For more information, please visit www.dermbiont.com.