Onychomycosis

Efinaconazole’s low binding affinity to keratin enables it to penetrate nails effectively to treat onychomycosis. Credit: Prabodha D Herath/Shutterstock. Almirall has completed the decentralised European regulatory procedure for efinaconazole, a triazole antifungal substance with the trade name Jublia, to treat onychomycosis. This is a significant step in enhancing Almirall’s medical dermatology portfolio in Europe and the procedure is the last step before European countries can issue national marketing authorisations. Onychomycosis, a fungal infection impacting an estimated 5.5% of the world population, accounts for half of all nail disorder consultations. It is a notoriously tenacious condition, often resistant to treatments. Efinaconazole’s low binding affinity to keratin, key in nail composition, enables it to penetrate nails effectively. In May 2022, Almirall initiated the regulatory submission process for efinaconazole in Germany and Italy, utilising the European decentralised procedure. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC Germany’s regulatory authority acted as the reference member state. Almirall research and development, chief scientific officer and executive vice-president Dr Karl Ziegelbauer stated: “The completion of the decentralised regulatory procedure for efinaconazole in Europe enables European countries to approve this advanced treatment option to support people with onychomycosis. “Efinaconazole as a topical treatment is a valuable addition to our expanding onychomycosis portfolio and we are looking forward to being able to offer it to European dermatologists and their patients in the near future.” In July 2021, the company obtained exclusive development and marketing rights for efinaconazole in Europe from Kaken Pharmaceutical . Kaken received an upfront cash payment from Almirall, along with milestone payments and royalties based on net sales of the product, which is currently available in the US, Canada, Korea, Hong Kong and Macau. It has been available in Japan under the trade name Clenafin since 2014. Almirall is currently collaborating with national regulatory authorities, with authorisations anticipated in the first half of 2025. In February 2024, Almirall entered a strategic collaboration with Microsoft for drug development in dermatology.

STOCKHOLM, Sept. 13, 2024 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) announces that the company has received information about clinical cure in a subset of patients in the ongoing North American Phase 3 study for MOB-015 against nail fungus. The number of patients who have achieved clinical cure in this blinded subset of patients is lower than the company's expectations, which necessitates that Moberg Pharma inform the market about this fact. The North American Phase 3 study is ongoing at 33 study centers in the US and Canada, including a total of 384 patients. The study constitutes an essential part of the clinical data required for the registration and commercialization of MOB-015 in the US and differs from previous studies with MOB-015, which is the basis for drug approval in 13 EU countries, by reducing the dosage – 8 weeks daily dosing followed by weekly maintenance treatment for 40 weeks, compared to daily dosing throughout the entire treatment period. In the process of preparing the database for upcoming topline data, the company has received information regarding clinical cure in a subset of patients in the study. Clinical cure is one of three parameters that together constitute the study's primary treatment goal, complete cure. All three parameters; clinical cure, negative fungal culture, and negative microscopy, need to be met for a patient to be considered completely cured. No information has been obtained about the other study parameters included in complete cure. The information obtained is blinded; no information has been received regarding which patient received active treatment or how many patients in the data subset received active treatment (patients in the study are randomized 2:1 to treatment with MOB-015 and vehicle). The total number of patients who have achieved clinical cure in this subset of patients is lower than the company's expectations, and Moberg Pharma assesses that the risk of not being able to commercialize the product in the US based on this study has significantly increased, which requires the company to inform the market of this fact. It is an absolute priority to protect the integrity of the study data, both as not to undermine the possibilities of using study results in discussions with regulatory authorities, and as there are patients with ongoing treatment in the study. Moberg Pharma will not speculate on possible outcomes or what this means for the future potential of MOB-015 and will await topline results to avoid drawing premature conclusions. "Our main priority is to protect the data integrity of the study. Together with our CRO, we will do our utmost to minimize the time from the last patient's last visit to top-line data, and our expectation is that these may be brought forward compared to the timelines previously communicated, before year-end" says Anna Ljung, CEO of Moberg Pharma. On September 13th, 2024, at 15:00 (CET), Moberg Pharma's CEO Anna Ljung, CMO Anders Bröijersén, and CSO Amir Tavakkol will answer questions during a telephone conference. The Q&A session will be held in English. To participate in the conference, please dial in on one of the numbers below before the conference starts: SE: +46 8 10 884 80 16. Access Code: 961943 US: +1 855 979 6654. Access Code: 961943 For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: [email protected] Anders Bröijersén, Chief Medical Officer, telephone: + 46 76 001 15 76, e- mail: [email protected] Amir Tavakkol, Chief Scientific Officer, telephone: +1 973 307 4856, e- mail: [email protected] About this information This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 8.00 am CEST on September 13th, 2024, through the contact persons above. About MOB-015 and Onychomycosis Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than hundred million patients worldwide and a clear demand for better products. MOB-015 is an in-house developed topical formulation of terbinafine, enabling effective concentrations of terbinafine to the nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. MOB-015 has been granted marketing authorization in 13 countries. The approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators), and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions. A North American Phase 3 study is ongoing at 33 study centers in the USA and Canada, with a total of 384 patients. The patients are being evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. About Moberg Pharma, Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's drug MOB-015, is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in Sweden under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB). This information was brought to you by Cision The following files are available for download: SOURCE Moberg Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

- Significant reduction of key cytokines IL-31, IL-36α, and IL-36γ - ISGA mean score of 0.83 with GX-03 topical pre-treatment vs 2.44 placebo, comparable to biologics - Company projects phase 1b/2 efficacy trials to begin in 2025 WESTLAKE VILLAGE, Calif., Aug. 5, 2024 /PRNewswire/ -- Turn Therapeutics, a pharmaceutical and medical device company focused on immunology, advanced wound care, and dermatology, announced today positive data results of GX-03 in a biomarker study intended to measure its immunological inhibitory effects during eczema induction. The study evaluated the immunological inhibitory effects of the topical application of Turn Therapeutics' candidate, GX-03, in an eczema model using C57BL/6 mice and a well-established NIH pre-treatment protocol. After a four-day pretreatment period with GX-03, disease induction was carried out over the following three days. Cytokine levels and average disease severity scores were then assessed using the ISGA (Investigator's Static Global Assessment) scale across all groups. GX-03 showed inhibition of key cytokines implicated in multiple dermatological conditions, including atopic dermatitis. IL-31 levels, considered to play a significant role in the pathogenesis of eczema and atopic dermatitis (AD), showed a reduction of 67.7% vs placebo [p-value (1.12×10−6)]. IL-36α and IL-36γ also demonstrated significant inhibition: 50% [p-value (3.0×10−6)] and 49% [4.35×10−8], respectively. IL-36α is a key cytokine driving a spectrum of dermatological pathologies while IL-36γ is largely associated with multiple forms of psoriasis. The ISGA is a 5-point rating scale that is recommended by the US Food and Drug Administration for assessing the severity of AD. ISGA success is a widely used endpoint in AD clinical studies. Following a pre-treatment regimen, Turn Therapeutics' candidate demonstrated a significant reduction in ISGA score to 0.8, indicating clear to almost clear, compared to 2.4 with placebo, or mild-moderate eczema. "This inhibition data is especially notable given that it was achieved via pre-treatment prior to disease induction, indicating powerful dermal penetration and lasting effects," said Bradley Burnam, founder and CEO of Turn Therapeutics. "With the data produced over the past couple of months detailing the potential efficacy in eczema, we look forward to entering the clinic with this non-steroid, non-injectable asset with a lengthy safety history in humans." The results of the study were recently featured in Dermatology Times. Turn Therapeutics' GX-03 formulation has a well-established safety history and has received FDA clearance in other indications that confirm its non-cytotoxicity and lack of sensitization potential. For more information, please see turntherapeutics.com. To request an interview with Turn Therapeutics' Founder and CEO, Bradley Burnam, contact [email protected]. To invest via limited online offering, click here. About Turn Therapeutics Turn Therapeutics is a pharmaceutical and medical device company focused on advanced wound and dermatologic care. Turn's technology targets broad indications with few safe or effective options, such as moderate to severe eczema and onychomycosis. Leveraging the guidance and data produced by medical experts, Turn's innovative flagship formula continues to suggest remarkable efficacy for a variety of indications. Visit turntherapeutics.com. Forward-looking Statements The statements contained herein may include prospects, statements of future expectations, and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance, or events may differ materially from those expressed or implied in such forward-looking statements. SOURCE Turn Therapeutics