Keratosis, Seborrheic

WEDNESDAY, Nov. 20, 2024 -- Teledermoscopy has high accuracy for detecting skin cancers, according to a research letter published online Nov. 9 in the Journal of the American Academy of Dermatology . Jenne P. Ingrassia, from New York Medical College in Valhalla, and colleagues conducted a prospective diagnostic accuracy study to compare the accuracy of telemedicine-based skin cancer detection to in-person evaluations. In addition, off-label use of Nevisense, a device to assess melanocytic skin lesions suspicious for melanoma for use in dermatologists' offices, was evaluated for improving accuracy of teledermoscopy. A total of 147 participants with 375 self-identified skin lesions were assessed. The researchers found that 97 percent of the skin lesions were benign. The most common diagnoses were seborrheic keratosis, common melanocytic nevus, solar lentigo, other, and hemangioma (38, 19, 10, 8, and 4 percent, respectively). Overall, 13 participants had a malignant neoplasm, with two melanomas. Eleven of 13 skin cancers were detected in face-to-face examination, with accuracy of 93 percent. The TeleTeam detected 11/13 skin cancers with clinical photos and dermoscopy alone (accuracy of 91 percent). The TeleTeam detected 12/13 skin cancers with Nevisense, but due to lower specificity, a high prevalence of benign lesions, and the rarity of atypical nevi and early-stage melanomas, accuracy decreased to 83 percent. Overall, 89 percent of participants who completed a postintervention questionnaire agreed or strongly agreed that they would feel more at ease having their worrisome spot examined by a teledermatologist versus not examined. "Our results support the potential utility of teledermoscopy to safely triage patient- and primary-care clinician-identified skin lesions for in-person evaluation," the authors write.

BOSTON--( BUSINESS WIRE )-- DermBiont , a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, today announced positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC). As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients. DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6. The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs). At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020. All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor. Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont said: “We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome. An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time.” SM-020 has been well tolerated to date with no drug-related adverse events and only rare and transient primarily mild-to-moderate severity application site reactions. The same drug product has also been shown to be extremely well tolerated by subjects with seborrheic keratoses (SK), having been administered by over 100 subjects with SKs twice daily for at least 28 days in prior clinical trials. Emma Taylor, M.D. and Chief Medical Officer at DermBiont, added: “SM-020 in vitro is highly potent at killing BCC cells and has a well-defined mechanism of action that hits established tumorigenesis pathways known to be the cause of BCCs, so the robust response that we are seeing in the clinic is not surprising.” Basal Cell Carcinoma is the most common cancer with over three million cases annually in the United States alone. A BCC that is at least 10mm in diameter and that has either failed or is not appropriate for conventional treatment is considered a laBCC. In the United States, over 10,000 individuals suffer from laBCC annually, at least 10,000 individuals suffer from Gorlin Syndrome, and more than 30,000 people suffer from high frequency sporadic BCC, with tens of thousands of individuals being diagnosed with multiple basal cell carcinomas annually. In parallel to ongoing pivotal trial-enabling nonclinical and CMC scale-up work, DermBiont plans to seek Orphan Drug and Fast Track Designations for the treatment of laBCC and the prevention of BCC in patients with Gorlin Syndrome, to be followed by pivotal trials in two orphan indications for the approval of SM-020 for treatment of laBCC and prevention of BCC in Gorlin Syndrome patients. Following the reprioritization of SM-020 for laBCC and Gorlin Syndrome, Dermbiont is evaluating options for its SK program. About DermBiont DermBiont is a clinical-stage biotechnology company advancing two first-in-class topical therapeutics with well-defined mechanisms of action to address patient needs in rare disease oncology and aesthetic dermatology. SM-020 for the treatment of laBCC and prevention of BCC in Gorlin Syndrome, and SM-030 for the treatment of melasma and other hyperpigmentation disorders of the skin. For more information, please visit www.dermbiont.com .

- 100% of 9 treated BCCs (1 superficial, 4 nodular, and 4 infiltrating) across 7 enrolled subjects to date demonstrate prompt, visible, and robust tumor responses during treatment with SM-020 1% BID for 28 days, resulting in partial or total reduction of clinically visible tumor. BOSTON, -- DermBiont, a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, today announced positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC). As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients. DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6. The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs). At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020. All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor. Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont said: “We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome. An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time.” SM-020 has been well tolerated to date with no drug-related adverse events and only rare and transient primarily mild-to-moderate severity application site reactions. The same drug product has also been shown to be extremely well tolerated by subjects with seborrheic keratoses (SK), having been administered by over 100 subjects with SKs twice daily for at least 28 days in prior clinical trials. Emma Taylor, M.D. and Chief Medical Officer at DermBiont, added: “SM-020 in vitro is highly potent at killing BCC cells and has a well-defined mechanism of action that hits established tumorigenesis pathways known to be the cause of BCCs, so the robust response that we are seeing in the clinic is not surprising.” Basal Cell Carcinoma is the most common cancer with over three million cases annually in the United States alone. A BCC that is at least 10mm in diameter and that has either failed or is not appropriate for conventional treatment is considered a laBCC. In the United States, over 10,000 individuals suffer from laBCC annually, at least 10,000 individuals suffer from Gorlin Syndrome, and more than 30,000 people suffer from high frequency sporadic BCC, with tens of thousands of individuals being diagnosed with multiple basal cell carcinomas annually. In parallel to ongoing pivotal trial-enabling nonclinical and CMC scale-up work, DermBiont plans to seek Orphan Drug and Fast Track Designations for the treatment of laBCC and the prevention of BCC in patients with Gorlin Syndrome, to be followed by pivotal trials in two orphan indications for the approval of SM-020 for treatment of laBCC and prevention of BCC in Gorlin Syndrome patients. Following the reprioritization of SM-020 for laBCC and Gorlin Syndrome, Dermbiont is evaluating options for its SK program. About DermBiont DermBiont is a clinical-stage biotechnology company advancing two first-in-class topical therapeutics with well-defined mechanisms of action to address patient needs in rare disease oncology and aesthetic dermatology. SM-020 for the treatment of laBCC and prevention of BCC in Gorlin Syndrome, and SM-030 for the treatment of melasma and other hyperpigmentation disorders of the skin. For more information, please visit www.dermbiont.com.