MC2 Therapeutics Ltd.

DURHAM, N.C. and COPENHAGEN, Denmark, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that EPI Health, a Novan Company, and MC2 Therapeutics presented data from a previously unpublished subgroup analysis of the U.S. Phase 3 pivotal study of WYNZORA® Cream at the Skin of Color Update 2022 Conference held September 9-11, 2022, in New York, NY. Published as a poster, this analysis from a previously completed Phase 3 randomized, multicenter, investigator-blind, parallel-group trial of WYNZORA® Cream (calcipotriene and betamethasone dipropionate) evaluated efficacy and convenience factors in skin of color patients compared to the total study population. Patients with skin of color (Fitzpatrick IV-VI) made up 36% of subjects in the WYNZORA® head-to-head study, and 8% were African American. The proportion of patients (37.4%) in the Fitzpatrick type IV-VI group achieving Physician Global Assessment (PGA) success (at least a 2-grade improvement from baseline and clear or almost clear) after 8 weeks of treatment with CAL/BDP (calcipotriene and betamethasone dipropionate) cream was similar to the total population (38.7%) and significantly different from CAL/BDP TS (topical suspension) (p=0.0042) and cream vehicle (p=0.0013). The change from baseline mPASI after 8 weeks of treatment in the skin of color population was 61.8% with CAL/BDP Cream and 47.7% with CAL/BDP TS (p=0.0003), compared to 62.2% CAL/BDP Cream and 52% CAL/BDP TS in the total population (p<0.0001). No cases of hypopigmentation were reported in the Phase 3 trial. This subgroup analysis shows that skin of color patients treated with CAL/BDP cream have similar efficacy to the total trial population. Patient convenience and satisfaction for CAL/BDP cream were scored similarly or higher in patients with skin of color than in the total trial population and compared to CAL/BDP TS. “Patients with skin of color are typically not well represented in topical psoriasis studies. This data enables us to understand the efficacy of WYNZORA® Cream in this population, which comprised more than one third of patients enrolled. The results from this analysis demonstrated similar efficacy and comparable or higher scores for convenience factors (such as how easy the treatment was to apply) in Fitzpatrick skin type IV to VI subjects, giving us further confidence in using WYNZORA® for these patients,” commented Fran Cook-Bolden M.D., Assistant Clinical Professor, Weill Cornell Medicine New York, NY and an investigator for the WYNZORA Cream US Phase 3 study. About the Poster Presentation: Title: Calcipotriene (CAL) and betamethasone dipropionate (BDP) cream demonstrates high efficacy and convenience in skin of color patients with plaque psoriasis Authors: Valerie Callender, MD, Susan Taylor, MD and Fran Cook-Bolden, MD 1Stein Gold et al, J Drugs Dermatol 2021;20(4) About WYNZORA® (calcipotriene and betamethasone dipropionate) Cream WYNZORA® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. WYNZORA® Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation. WYNZORA® Cream was uniquely designed to provide patients a treatment option in their daily routines by combining the three essentials of a topical therapy in one single product namely high efficacy, a favorable safety profile and convenience of use. WYNZORA Cream - Important Safety Information Tell your healthcare provider about all your medical conditions and all the medicines you take, including any corticosteroid medicines and any other products containing calcipotriene. Do not use other products containing calcipotriene or a corticosteroid medicine without talking to your healthcare provider first. WYNZORA Cream may cause side effects, including: Too much calcium in your blood or urine and/or adrenal gland problems Cushing's syndrome, a condition that happens when your body is exposed to large amounts of the hormone cortisol High blood sugar and sugar in your urine Vision problems, including an increased risk of developing cataracts and glaucoma. The most common side effects include upper respiratory infection, headache, and application site irritation. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects. This summary is not comprehensive. Visit www.wynzora.com to obtain the FDA-approved Full Prescribing Information. About Novan Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases. Our goal is to deliver safe and efficacious therapies to patients, including developing product candidates where there are unmet medical needs. We are developing SB206 (berdazimer gel, 10.3%) as a topical prescription gel for the treatment of viral skin infections, with current emphasis on molluscum contagiosum. Novan recently completed the acquisition of EPI Health. EPI Health equips the company with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams. Following the acquisition, the company employs approximately 100 staff, including sales personnel currently covering 42 territories, and promotes products for plaque psoriasis, rosacea, acne and dermatoses. Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications. About MC2 Therapeutics A/S MC2 Therapeutics A/S is a privately held commercial stage pharmaceutical company committed to research in skin biology and development of novel treatment paradigms for people with autoimmune and chronic inflammatory skin conditions. Its innovative approach to address complex challenges more effectively is anchored in deep understanding of the skin biology combined with learnings from the pathophysiology across disease segments. Fueled by an entrepreneurial mindset and creativity, MC2 Therapeutics aims to set new standards in treatment satisfaction for people with skin conditions.

COPENHAGEN, Denmark, Sept. 14, 2022 /PRNewswire/ -- MC2 Therapeutics A/S, a commercial stage pharmaceutical company, engaged in research in skin biology and development of novel treatment paradigms for autoimmune and chronic inflammatory skin conditions, announces that the first patients have been dosed in its European Phase 2 trial, MC2-25-C1, evaluating the safety and efficacy of MC2-25 Cream compared to MC2-25 vehicle in treating moderate to severe CKD-aP in patients with CKD stages 3-5. MC2-25 Cream is an innovative new drug candidate, addressing MC2's new biological treatment paradigm for treatment of urea associated skin diseases. MC2-25 Cream inhibits carbamylation in skin, and thereby potentially can provide relief of the severe skin dryness and debilitating itch, which CKD patients suffer from. "The initiation of the Phase 2 trial with MC2-25 Cream in Europe marks the first step in our journey to leverage our scientific breakthrough discovery of how to treat urea associated skin diseases, for which there are currently limited or no approved therapies," says Jesper J. Lange, President and CEO of MC2 Therapeutics and added: "As part of our commitment to developing this novel treatment paradigm, we also plan to engage with regulatory authorities in the US in Q4 2022 as part of our global CKD-aP program." "CKD-aP severely impacts the quality of life of CKD patients stages 3-5 with very few treatment options. There are no approved treatments for stages 3-4 patients and no therapies known to treat the damage in the skin caused by the disease. Based on the novel treatment paradigm targeting carbamylation in skin, MC2-25 Cream has the potential to become the first therapy addressing the origin of CKD-aP for millions of CKD patients," says Kieran McCafferty, MD, at Barts Health NHS Trust and Senior Lecturer at Queen Mary University London and principal investigator of the MC2-25-C1 trial and continues: "The trial has been endorsed by Kidney Research UK and is a highly appreciated opportunity for our CKD-aP patients to contribute to the clinical development of this exciting drug candidate." About MC2-25 Cream The active component of MC2-25 Cream is a di-peptide, which is formulated in MC2 Therapeutics' proprietary formulation and drug delivery system – PAD Technology™. MC2-25 Cream is an effective isocyanate scavenger showing >90 % inhibition of protein carbamylation and counteracting the morphological skin changes induced by carbamylation as demonstrated in an in vitro reconstructed human uremic skin model. Isocyanate is a very reactive molecule known both to be neurotoxic and to readily react with proteins, peptides and amino acids present in the body and skin. In CKD patients carbamylation of amino acids and proteins is highly upregulated and believed to be a key contributor to the root cause of CKD-aP. For more information about MC2 Therapeutics' breakthrough discovery of a novel biological treatment paradigm for urea associated skin diseases, please see Press Release of September 1st, 2022 . About the MC2-25 Phase 2 Trial The trial is a Phase 2, randomized, multicenter, double-blind, parallel-group trial in subjects with CKD-aP stages 3-5. The trial is expected to enroll approximately 108 patients in about 23 centers in Europe. Subjects will apply trial medication topically twice daily for 12 weeks. The primary objective is to compare therapeutic efficacy of MC2-25 Cream versus vehicle cream, as well as to characterize the safety profile of MC2-25 Cream in subjects with CKD-aP. The primary efficacy endpoint is the mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) from baseline to week 12. Secondary endpoints will be assessed, including treatment success according to responder endpoints, as well as various other patient and physician reported outcomes. Topline results are expected in Q1 2024. About CKD-aP CKD-aP effects more than 35 million people in the US and EU, of which the vast majority (~30 million) are non-dialysis patients (stages 3 and 4) who currently have no approved treatment options. People suffering from CKD have severe dry skin and evidence of damaged nerve fibers in the skin. CKD-aP is a severe condition, which leads to an overall increased mortality risk, as well as higher frequency of depression and reduced quality of life. About MC2 Therapeutics A/S MC2 Therapeutics A/S is a privately held commercial stage pharmaceutical company committed to research of skin biology and development of novel treatment paradigms for people with autoimmune and chronic inflammatory skin conditions. Its innovative approach to address complex challenges more effectively is anchored in deep understanding of the skin biology combined with learnings from the pathophysiology across disease segments. Fueled by an entrepreneurial mindset and creativity, MC2 Therapeutics aims to set new standards in treatment satisfaction for people with skin conditions.