IL-31RA

The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer. The therapy, dubbed CAM2029, had a PDUFA date of Oct. 21 for acromegaly, but production issues were found at a third-party factory in September. There were no issues with the candidate’s efficacy or safety, Camurus said in a Tuesday release. CAM2029 does not have a new decision date, but Camurus said “timely resolution of the CRL” will depend on the unnamed third-party manufacturer’s responses. Labeling discussions for the asset were already in the final stages when the CRL was given, the company said. Acromegaly occurs when the body makes too much growth hormone, which leads to abnormally large hands and feet. Subcutaneously administered CAM2029 features a peptide inhibitor of growth hormones called octreotide. Camurus announced data from a pair of Phase 3 trials investigating CAM2029 in June and July 2023, showing acromegaly symptoms improved in patients. In May, Camurus said the EMA had received its regulatory application. Jefferies analysts said the delay could lead to Camurus launching its drug later than expected. Crinetics Pharmaceuticals has its own acromegaly candidate and announced the submission of its FDA application last month. CAM2029 is also being investigated for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.

Administration of GLP-1 Receptor Agonists and CB-1 Receptor Antagonists Enhanced by Invisicare Topical / Transdermal Delivery System LAS VEGAS, NV / ACCESSWIRE / May 29, 2024 / Skinvisible Pharmaceuticals, Inc. ("Skinvisible" or "the Company"), (OTCQB:SKVI), an innovative pharmaceutical research and development company, announced a major advancement in the battle against obesity. The Company has achieved a significant milestone by officially filing a provisional patent application covering formulations that leverage the Company's proprietary delivery technology Invisicare® for the transdermal administration of obesity drugs. Titled "Transdermal Delivery Composition for Delivery of CB-1 Receptor Antagonists and/or GLP-1 Receptor Agonists, and Method of Delivery," this patent filing ushers in a new era of efficient and convenient obesity drug delivery solutions. The patent application focuses on Invisicare; a patented transdermal delivery technology designed to incorporate CB-1 receptor antagonists and/or GPL-1 receptor agonists, two classes of drugs known for their potential in obesity management, into a lotion that is applied topically to the skin using a metered applicator. Studies have demonstrated the superior transdermal penetration and controlled release of other active compounds using Invisicare's innovative technology; with certain actives exhibiting up to a tenfold increase in transdermal delivery effectiveness. By utilizing Invisicare, Skinvisible aims to not only offer patients a convenient and effective alternative to traditional oral or injectable therapies but to also enhance drug efficacy and potentially significantly reduce side effects as transdermal delivery avoids first-pass metabolism. Additionally, for long-term treatment of obesity, a transdermal delivery system could feasibly provide a convenient method for administering maintenance doses of anti-obesity medications. The global obesity drug market is poised to exceed $30 billion by 2027, propelled by the escalating prevalence of obesity worldwide and the eagerly anticipated advent of revolutionary anti-obesity medications. Nonetheless, the impediment posed by needles and injections remains a formidable barrier to access and compliance. Skinvisible's proprietary transdermal delivery technology overcomes this obstacle, unlocking the full therapeutic potential of CB-1 and GLP-1 targeting drugs. "Our transdermal technology has the potential to revolutionize how obesity drugs are administered, granting patients access to potent weight loss medications through the ease and convenience of a metered dose of lotion simply applied to the skin," remarked Terry Howlett, CEO of Skinvisible Pharmaceuticals. "This needle-free approach holds immense promise in enhancing treatment adherence and broadening the accessibility of obesity therapies to countless individuals grappling with weight-related challenges." He added, "This groundbreaking patent application highlights our proficiency in transdermal delivery and underscores our commitment to leveraging this capability to reshape treatment standards." Skinvisible is actively pursuing strategic partnerships with pharmaceutical and/or biotech companies to facilitate the introduction of the first transdermal obesity therapies to market and to explore the application of its delivery platform across diverse disease domains. For more information on Skinvisible Pharmaceuticals, partnerships and investment opportunities, please visit or contact info@skinvisible.com. About Skinvisible Pharmaceuticals, Inc. Skinvisible Pharmaceuticals, a wholly-owned subsidiary of Skinvisible, Inc., is a pioneering research and development company specializing in licensing proprietary topical and transdermal formulations utilizing its patented polymer skin delivery system; Invisicare. This innovative technology provides life-cycle management and distinctive enhancements for both topical and transdermal delivery products. Invisicare formulated as a lotion or cream, effectively adheres active ingredients to the skin facilitating a controlled release of the active to and/or through the skin and into the blood stream over time. Skinvisible has recently developed formulations for the potential treatment of obesity, along with over forty dermatology related conditions including rare skin disorders. For further details, please visit . Forward-Looking Statements: This press release contains 'forward looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby including with respect to the possible development of any such products, the acceptance of any such products in the market place, the size of any such markets, the ability of any product candidates to be approved by the U.S. Food and Drug Administration among others. Such statements involve certain risks and uncertainties associated with an emerging company. Actual results could differ materially from those projected in the forward-looking statements as a result of risk factors discussed in Skinvisible, Inc. reports on the U.S. Securities and Exchange Commission (including, but not limited to, a report on Form 10Q for the period ending March 31, 2024). ### Contacts: Strategic Partnerships: Doreen McMorran - doreen@invisicare.com Corporate Inquiries: info@skinvisible.com Office Number: 702-433-7154 (PST) SOURCE: Skinvisible, Inc. View the original press release on accesswire.com

The U.S. Food and Drug Administration (FDA) has accepted Galderma’s Biologics License Applications for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab was granted U.S. FDA Priority Review for prurigo nodularis. The European Medicines Agency has also accepted the Marketing Authorization Applications for nemolizumab in prurigo nodularis and atopic dermatitis. Further submissions to regulatory authorities in additional countries are planned in 2024. ZUG, Switzerland--(BUSINESS WIRE)-- Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit IL-31 signaling to provide safe and rapid relief from the most burdensome symptom of both skin conditions: itch.1-7 The U.S. FDA has granted nemolizumab Priority Review for the treatment of prurigo nodularis. This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023. Priority Review is granted for medicines that would significantly improve the treatment, diagnosis or prevention of serious conditions. The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis. Galderma is planning for multiple regulatory submissions in 2024. “The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life. We are thankful to the patients and medical experts whose insights informed our clinical trials, which assessed nemolizumab’s ability to reduce the symptoms of itch and skin lesions. We are one step closer to delivering this innovative solution to those in need and look forward to the outcomes of these filing decisions.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase III OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in patients with prurigo nodularis.8,9 Results from the OLYMPIA program demonstrated nemolizumab’s ability to rapidly improve itch, clear skin nodules and reduce sleep disturbance. In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary endpoints compared to placebo after 16 weeks of treatment:10,11 More than half of nemolizumab-treated patients achieved an at least four-point reduction in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS; 8% and 56% in OLYMPIA 1 and 2, respectively, compared to 17% and 21% in the placebo groups; p<0.0001). On average, a third of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (IGA) score (26% and 38% in OLYMPIA 1 and 2, respectively, compared to 7% and 11% in the placebo groups; p<0.0001). The trials also met all key secondary endpoints confirming rapid onset of action on itch and sleep disturbance within four weeks of treatment initiation: 41% of nemolizumab-treated patients achieved an at least four-point reduction in itch in both the OLYMPIA 1 and 2 studies, as measured by the PP-NRS score, compared to 6% and 8% in the placebo groups (p<0.0001), respectively. In OLYMPIA 2, nearly four times as many patients in the nemolizumab-treated group (37%) versus placebo (10%) achieved significant and clinically meaningful improvements in sleep disturbance, as measured by a four-point improvement on the sleep disturbance numerical rating scale (SD-NRS; p<0.0001). The phase III OLYMPIA clinical trial program is the largest clinical trial program conducted in prurigo nodularis to date, with more than 500 patients enrolled, and the only one to include a long-term extension study. The regulatory submissions of nemolizumab in atopic dermatitis are based on data from the phase III ARCADIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in adolescents and adults with moderate to severe atopic dermatitis.12,13 In the ARCADIA program, nemolizumab clinically improved skin lesions and rapidly improved itch and sleep disturbance. Both ARCADIA trials showed clinically and statistically significant improvements in co-primary endpoints, compared to placebo, after 16 weeks of treatment:14 More than a third of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions when assessed using the IGA score (36% and 38% in ARCADIA 1 and 2, respectively, compared to 25% and 26% in the placebo groups; p<0.001). More than 40% of nemolizumab-treated patients achieved a 75% reduction in the Eczema Area and Severity Index (44% and 42% in ARCADIA 1 and 2, respectively, compared to 29% and 30% in the placebo groups; p<0.001). The trials also met all key secondary endpoints confirming rapid onset of action on itch and sleep disturbance, with statistically significant and clinically meaningful improvements observed as early as one week after treatment initiation. Results at week 16 showed: Nearly half of nemolizumab-treated patients achieved an at least four-point reduction in itch intensity as measured by the PP-NRS score (49% and 48% in ARCADIA 1 and 2, respectively, compared to 21% in the placebo groups; p<0.0001, MI-MAR analysis). 44% and 38% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved an at least four-point reduction in sleep disturbance as measured by the SD-NRS score (compared to 22% and 20% in the placebo group; p<0.001, MI-MAR analysis). Nemolizumab was generally well tolerated and its safety pro similar to placebo across the OLYMPIA and ARCADIA clinical trial programs.10,11,14 About prurigo nodularis Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.5,15-16 Prurigo nodularis is an underrecognized and underdiagnosed skin disease.15,17 About the OLYMPIA phase III clinical trial program The OLYMPIA program included two identical, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2.8,9 These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis after a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.8,9 The two phase III OLYMPIA trials met all primary and key secondary endpoints.10,11 Results showed that treatment with nemolizumab monotherapy resulted in significant and clinically meaningful improvements on itch, sleep disturbance and skin lesions in adult patients with prurigo nodularis, with early and sustained improvements on itch observed by week four.10,11 About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.19,20 It impacts more than 230 million people worldwide and is the most common inflammatory skin disease.19 About the ARCADIA phase III clinical trial program The ARCADIA program included two identical, pivotal phase III clinical trials which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.12,13 These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroid therapy or topical calcineurin inhibitors).12,13 The trials were conducted in adolescent (12 years and over) and adult patients with moderate to severe atopic dermatitis for an initial treatment phase of 16 weeks, followed by a maintenance treatment phase for up to 48 weeks.12,13 The two phase III ARCADIA trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab rapidly and significantly improves itch, skin lesions and sleep disturbance in patients with moderate to severe atopic dermatitis.14 About nemolizumab Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis. Nemolizumab is under regulatory review for the treatment of patients with prurigo nodularis and moderate to severe atopic dermatitis with the U.S. Food and Drug Administration and European Medicines Agency. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: . References: Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi:10.1111/ced.14722 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi:10.1016/j.anai.2018.07.006 Bağci IS and Ruzicka T. IL-31: A new key player in dermatology and beyond. J Allergy Clin Immunol. 2018;141(3):858-866. doi:10.1016/j.jaci.2017.10.045 Dillon SR, et al. Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice [published correction appears in Nat Immunol. 2005;6(1):114]. Nat Immunol. 2004;5(7):752-760. doi: 10.1038/ni1084 Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/j.jaci.2019.08.013 Halvorsen JA, et al. Suicidal ideation, mental health problems, and social function in adolescents with eczema: a population-based study. J Invest Dermatol. 2014;134(7):1847-1854. doi:10.1038/jid.2014.70 ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online: . Last accessed February 2024 ClinicalTrials.Gov. An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis. Available online: Last accessed February 2024 Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. DOI: 10.1056/NEJMoa2301333 Ständer S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1). Late-breaking abstract presented at EADV 2023. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: . Last accessed February 2024 ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: Last accessed February 2024 Silverberg J, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented at EADV 2023 Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/j.jaad.2020.04.183 Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042 Kwatra SG, et al. Patient journey and the burden of systemic comorbidities and sequalae in prurigo nodularis. J Drugs Dermatol. 2023;22(12): 12-14. doi:10.36849/JDD.SF365502 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140-6736(20)31286-1 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 View source version on businesswire.com: Contacts Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Source: Galderma View this news release online at: