IL-31

Attovia Therapeutics is turning fundraising announcements into an annual tradition. In June 2023, the San Carlos, CA-based startup launched with $60 million. Then in May 2024, it announced a $105 million Series B . And now the startup has raised $90 million in a Series C, it announced Tuesday. The new round took just three months to put together, CEO Tao Fu told Endpoints News. “Considering the environment, it is quite fast,” Fu said. Attovia’s pipeline of multispecific biologics is rooted in a biologics platform that it licensed from precision proteomics company Alamar Biosciences. Fu said the money, coupled with existing funds, will bankroll it through Phase 2 proof-of-concept trials for its first two biparatopic nanobodies. Attovia’s speedy fundraise came together despite a bleak backdrop for the broader biotech field, in which many startups are struggling to raise cash in later-stage rounds. A few other biotechs have pulled together large, late-stage private rounds this year, but the pace of large rounds is down slightly from last year, according to data collected by Endpoints. Attovia is in Phase 1 with an anti-IL-31 biologic called ATTO-1310. The company hopes to treat chronic pruritus of unknown origin with the quarterly, under-the-skin injectable. It would compete with Galderma, which also has an anti-IL-31 monoclonal antibody, called Nemluvio, on the market for prurigo nodularis and atopic dermatitis . Jefferies analysts have predicted more than $2 billion in peak sales for the drug. Galderma’s drug targets the IL-31 receptor, whereas ATTO-1310 goes after the IL-31 ligand, Fu said. Attovia hopes that will give its investigational medicine a leg up in terms of quicker itch relief. Behind that asset is another anti-IL-13xIL-31 bispecific for atopic dermatitis and other inflammatory skin conditions. Called ATTO-3712, it will enter Phase 1 in the second half of this year, Fu said. Another multispecific program is in the works for inflammatory bowel disease, the CEO said. The startup could consider partnering out its work in antibody-drug conjugates, Fu said. Deep Track Capital led the round. Attovia’s roster of investors also includes Vida Ventures, Sanofi’s venture arm, Mirae Asset Capital Life Science, Frazier Life Sciences, venBio, Goldman Sachs Alternatives and Cormorant Asset Management, among others. As part of the funding, Deep Track managing director Rebecca Luse joined Attovia’s board. Luse also joined the board of Imbria Pharmaceuticals as part of the cardiometabolic startup’s $57.5 million Series B last week.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. The UK regulator has specifically approved the drug to treat atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents aged 12 years and older with a body weight of at least 30kg and for adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy. Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 1.6 million people in the UK, while prurigo nodularis, which causes intense itch and thick skin nodules, affects approximately 18,000 people in the UK. Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions. Nemluvio, which was initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction. The MHRA’s decision comes shortly after the European Commission authorised Nemluvio for both conditions and makes the drug the first approved monoclonal antibody in the UK that specifically targets interleukin-31 receptor alpha. The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. Baldo Scassellati Sforzolini, global head of research and development at Galderma, said: “[Nemluvio’s] approval in the UK… was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programmes, which show that [it] has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.”

New data on Nemluvio® (nemolizumab), including an oral e-poster presentation characterizing the impact of Nemluvio in different pruriginous lesion types in prurigo nodularis from the phase III OLYMPIA program, and post-hoc analyses exploring the continuous response of Nemluvio up to 56 weeks in atopic dermatitis patients from the ARCADIA 1&2 trials and long-term extension study who had partial or no disease response at week 16 The latest data from the phase III READY-4 and phase IIIb RELAX studies of ready-to-use liquid neuromodulator Relfydess® (RelabotulinumtoxinA), which has previously demonstrated a six-month clinical effect and rapid onset from day one for frown lines and crow’s feet, in the phase III READY clinical trial program1-3 Updates on Restylane® and Sculptra®, including data from a study exploring the benefits of Restylane Lyft™ or Contour™ with Sculptra in patients with medication-driven weight loss with associated facial volume loss, as well as new data from Galderma’s acne and sensitive skin product portfolio With 22 presentations in total, the extent and range of data to be shared underscore the pace of Galderma’s growth journey, which AAD attendees can further explore at booth #2021 Zug, Switzerland – March 3, 2025 – Galderma will present updates from across its broad dermatology portfolio at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place from March 7-11, 2025 in Orlando, Florida. The company will present 22 e-posters – including two oral presentations – with updates on a number of its innovative products, including Nemluvio, Sculptra, Restylane and Relfydess. These presentations combined reinforce the strength of Galderma’s growth journey, its status as the pure-play category leader in dermatology, and its innovative pipeline. “We’re bringing impactful new science to this year’s AAD meeting, with new data on Nemluvio – our treatment for prurigo nodularis and atopic dermatitis – and the latest from our Dermatological Skincare and Injectable Aesthetics portfolios. This demonstrates how Galderma continues to move from strength to strength, as a category leader in dermatology with a strong portfolio spanning the full spectrum of this fast-growing market.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA New data on Nemluvio reinforce its benefit for a broad range of patients with prurigo nodularis and atopic dermatitis. An oral presentation will report new data on the efficacy of Nemluvio treatment up to Week 16 across different pruriginous lesion types in patients with prurigo nodularis from the phase III OLYMPIA program. This will be presented on Friday, March 7. The company will also share data demonstrating the continuous response with Nemluvio up to 56 weeks in patients with moderate-to-severe atopic dermatitis who had a partial or no response to treatment at Week 16 in the ARCADIA 1&2 trials and long-term extension study. Alongside this, real-world evidence on atopic dermatitis will be shared, including an oral e-poster presentation with findings from a retrospective analysis of access disparities for atopic dermatitis patients across ethnic groups using the U.S. Medicaid database (Sunday, March 9), and data exploring the association between itch severity and initiation of biologic therapy. On Sunday, March 9, Galderma will also host an Industry Session Theatre titled ‘Targeting the IL-31 Neuroimmune Pathway: Transforming Itch and Inflammation Outcomes’. Presented by Dr. Jonathan Silverberg and Dr. Sarina Elmariah, this patient and expert panel discussion will delve into the crucial need to address neuroimmune interactions with atopic dermatitis and prurigo nodularis, the impact of IL-31, and how a targeted treatment improves real patient outcomes. Galderma will also present the latest data from across its Injectable Aesthetics portfolio, including updates on Restylane, Sculptra, and Relfydess. Interim data from a study exploring the benefits of Restylane Lyft or Contour with Sculptra in patients with medication-driven weight loss with associated facial volume loss will be shared. Results from a comparative study evaluating the synergistic effects for midface improvement when pairing Sculptra with a skincare regimen will also be presented, as well as a comparative analysis of suggested genetic pathways affected by Sculptra vs another biostimulator, and consensus and evidence-based recommendations on the impact of minimally invasive treatments on subsequent facial surgery for additional aesthetic enhancement. Additional data from Galderma’s Restylane portfolio includes the first ever ultrasound comparison of the tissue integration, dynamic support, and lifting capacity of Restylane Contour versus another rheologically different hyaluronic acid filler. Data from an AI-enabled Manufacturer and User Facility Device Experience database analysis of delayed complications with hyaluronic acid fillers will also reveal technology-based differences. Finally, data from the phase III READY-4 study, designed to evaluate the safety of Relfydess for the long-term treatment of moderate-to-severe frown lines and crow’s feet, as well as from the phase IIIb RELAX study, evaluating the long-lasting efficacy and satisfaction of Relfydess in adults with moderate-to-severe frown lines over a 12-month period, will be presented. A separate subgroup analysis of pooled phase III data will explore the benefits of Relfydess treatment for frown lines and crow’s feet of different baseline severity. These presentations build on previously announced data from the READY clinical trial program, which demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with Relfydess.1-3 Galderma will also present updates on its product portfolio for sensitive skin, including a dermal patch for acne-prone skin, a Ceramide Serum and Vitamin C Serum, and a novel cream designed to improve the appearance of aging skin. In acne, results of a worldwide profiling survey on the association between adult acne and sensitive skin will be shared. Presentations on Galderma’s CTMP™: Cleanse, Treat, Moisturize, Protect regimen will also reveal its impact on adherence, treatment outcomes, patient satisfaction, and overall skin quality in patients with acne and sensitive skin. More details on Galderma’s scientific presentations at AAD can be found here. Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.4,5 Nemluvio has been approved by the European Commission for both moderate-to-severe atopic dermatitis and moderate-to-severe prurigo nodularis in the European Union (EU).6 It is now approved in the EU for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.6 The U.S. FDA has also approved Nemluvio for the treatment of adults with prurigo nodularis and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.7 Nemluvio is also under review for the treatment of both diseases by several additional regulatory authorities around the world. Further submissions to regulatory authorities in additional countries are ongoing. Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.8-10 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.1-3,8-10 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.8-10 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. RelabotulinumtoxinA is an investigational drug product in the U.S. Following the completion of the European Decentralized Procedure resulting in a positive decision for the use of Relfydess, Galderma has received national approvals in 14 European countries, as well as a marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Galderma (SIX: GALD) is the 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: www.galderma.com. For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43