– Phase 2 proof of concept trial met primary endpoint of a one-point improvement in PLA score at last visit and safety via local tolerability in 35 patients with seborrheic keratoses (SKs) target lesions with baseline PLA scores of 2 or 3 –
– Over 80% of SKs treated for 14 to 28 days with SM-020 gel 1.0% had at least a one-point improvement in PLA score at last visit –
– SM-020 Investigational New Drug application filing expected in Q2 2023 –
BOSTON–(BUSINESS WIRE)–DermBiont, a clinical-stage biotechnology company that is advancing targeted topical therapeutics for the treatment of a variety of dermatological indications, today announced that its Phase 2 adaptive design trial with of investigational drug SM-020 gel 1.0% met its primary endpoint of a one point improvement in Physician’s lesion assessment (PLA) score at last visit and safety via local tolerability, as well as key multiple secondary endpoints including complete clearance of treated lesions. SM-020 is a selective and potent AKT inhibitor applied by patients at home to their seborrheic keratoses (SK) lesions. Dr. Karl Beutner, Co-Founder and Chief Executive Officer of DermBiont, presented the trial results at the Late Breakers session of the American Academy of Dermatology (AAD) Annual Meeting, taking place in New Orleans, LA from March 17-21, 2023.
SKs are the most common benign tumors of the skin, with estimates of at least 80 million Americans and a quarter of the global population impacted by them. SKs are initiated by clonal mutations and sustained by activation of AKT which blocks normal timed cell death (apoptosis). SKs are currently treated with ablative surgical procedures and there is currently no available topical therapy for these tumors.
Prior to the Phase 2 trial of SM-020, the topical therapy was demonstrated to induce apoptosis of SK cells in vitro in cell-based assays as well as ex vivo in SK explant studies. DermBiont’s Phase 2 proof-of-concept, adaptive open-label trial tested SM-020 gel 0.1% and 1.0%, enrolling 35 subjects with 4 SK target lesions across seven treatment cohorts. SKs were classified based on Physician’s Lesion Assessment (PLA) scores as follows: PLA 3 (thick: a visible, elevated SK lesion (thickness >1mm), PLA 2 (thin: a visible, elevated SK lesion (thickness ≤1mm), PLA 1 (near clear: a visible, not elevated SK lesion with a surface appearance different from the surrounding skin), and PLA 0 (no visible SK lesion with a surface appearance no different from the surrounding skin). In the clinical trial only PLA 2 and 3 SKs were treated.
All seven cohorts saw improvement and clearance of SKs, with the effect being most pronounced in the second of seven cohorts of subjects treated with SM-020 gel 1% applied BID for 28 days, with 100% (n=14) of SKs achieving a one-point or greater drop in PLA score and 57% (n=8) of SKs with a PLA score of 0 (complete clearance) as of last follow-up visit on Day 98. SM-020 was also very well tolerated with no drug-related adverse events and only rare local tolerability reactions, most commonly erythema and pruritis that were nearly exclusively mild in severity and transient in duration.
“The results of this trial have defined a highly effective, and very well tolerated treatment regimen that we will now advance to a larger, vehicle-controlled trial,” stated Karl Beutner, M.D., Ph.D., and CEO of DermBiont. “The current standard of care for treatment of patients’ SKs involves painful and destructive surgical procedures, including cryosurgery that carries a risk of both scarring and post-inflammatory hyperpigmentation and hypopigmentation. We believe that SM-020 has the potential to provide patients with a safe, well-tolerated, and easy to apply product to treat their SK lesions at home, and we look forward to continuing development of this product.”
SM-020 Gel 1% 14- and 28-day BID Results (Cohorts 1, 2, 3 and 5)
- 36% (n=20/55) of SK lesions treated for 28 days cleared completely, reaching a PLA score of PLA 0.
- 64% (n=35/55) of SK lesions treated for 28 days were clear or nearly clear, reaching a PLA score of PLA 1 or PLA 0.
- 80% (n=44/55) of SK lesions treated for 28 days experienced at least a one-point drop in their PLA score.
- All treatment arms were well tolerated with no drug-related adverse events or serious adverse events.
- There were rare and almost exclusively mild (only one moderate) transient application site reactions across patient-reported and investigator-measured reactions, including: pain, pruritus, erythema, edema, and scabbing. No subjects ended treatment due to tolerability issues.
“We are pleased to have presented positive results from our Phase 2 adaptive, open-label trial with SM-020 at the prominent AAD annual meeting. SM-020’s demonstration of 36% total target lesion clearance, and at least a partial response in 100% of lesions when treating SKs for 28 days with SM-020 1% is an important breakthrough for patients seeking an alternative to the current standard of care ablative treatments,” said Dr. Emma Taylor, M.D., Chief Medical Officer at DermBiont. “Most importantly, our Phase 2 study delivered the intended information that we hoped for to help define an appropriate and effective dosing regimen moving forward, as well as striking efficacy results. We are excited about our development achievements as well as the asset’s potential to provide patients with a new treatment for seborrheic keratoses. As a board-certified, practicing medical dermatologist, I am excited about the prospect of offering patients a safe and effective topical alternative to ablative procedures that patients may currently avoid due to pain and risks of hyperpigmentation and hypopigmentation, particularly for people of color.”
Based on the trial results DermBiont expects to file its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in Q2 2023, and subsequently initiate a Phase 2b trial in 2023.
About SM-020
SM-020 is an AKT kinase inhibitor. AKT kinase, also known as Protein Kinase B (PKB), is a central node in the tyrosine kinase/PI3K/AKT/mTOR and Ras/mitogen-activated protein kinase pathways, which are tumorigenesis/tumor suppression pathways. AKT inhibits apoptotic mechanisms and is involved in cellular survival pathways, can promote protein synthesis, and is important in cellular pathways promoting tissue growth. Apoptosis is the normal timed death of a cell and an increase in AKT activity can prevent apoptosis or normal cell death and promote tumor growth. SKs are proliferations of benign tumor cells, which can be explained by increased AKT phosphorylation and activity, as well as a decrease in cell death. AKT inhibitors can therefore block AKT activity, enabling apoptosis and cell death of SK cells.
About DermBiont
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.
Contacts
Nick Colangelo
Gilmartin Group
Nick@GilmartinIR.com
+1 (339) 225-1047