Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin
Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine that plays a role in driving itch – the main symptom of CPUO – and inflammation and fibrosis, which are hallmarks of SSc. 1,3,4
'Investigating nemolizumab in two new trials in Systemic Sclerosis and Chronic Pruritus of Unknown Origin, both of which are associated with poor patient outcomes and low quality of life, underscores our commitment to addressing skin conditions with high unmet needs. These trials may help us better understand these complex diseases and offer hope for patients seeking relief from these severe and potentially life-threatening conditions.'
BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
GLOBAL HEAD OF R&D
GALDERMA
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Systemic Sclerosis (SSc)
SSc is a rare, potentially fatal autoimmune disease that causes inflammation and fibrosis (hardening) of the skin and internal organs. 1 It most commonly affects women between the ages of 30 and 50 years old, often leading to a lower quality of life and a much higher risk of death compared to healthy people of the same age. 2,8 Currently, there are no approved therapies that address the disease as a whole, highlighting the urgent need for effective treatments. 1,2,8
Galderma's phase II proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled study investigating the pharmacokinetics and pharmacodynamics of nemolizumab in adults with SSc. Patient enrollment is planned to begin in H2 2025, with completion anticipated in 2028. This trial represents a significant step towards addressing the remaining unmet treatment needs in SSc and demonstrates Galderma's commitment to driving progress for patients living with this disease.
The study was designed in collaboration with a Steering Committee of world-leading rheumatology and dermatology experts, including lead trial investigator, Professor Oliver Distler, M.D., Zürich, Switzerland; Professor Dinesh Khanna, M.D., Director of the Scleroderma Program, University of Michigan, United States (U.S.); Professor Robert Spiera, M.D., Director of the Scleroderma, Vasculitis and Myositis Center, Hospital for Special Surgery, New York, U.S.; and Professor Johann Gudjonsson, M.D., PhD, Dermatologist, University Hospital Michigan, U.S.
The trial is expected to be conducted in several countries in North America, Europe and South America. More information about the study will be made available soon on the clinicaltrials.gov website.
'Systemic Sclerosis can have a profound impact on both the quality and length of a person's life. It causes the skin to harden, damages blood vessels, leads to joint pain, and can result in serious fibrosis in multiple internal organs, sometimes with life-threatening consequences. With no currently approved treatments that are indicated to treat the several symptoms this autoimmune disease presents, I look forward to investigating the role that nemolizumab could potentially play in this condition.'
PROFESSOR OLIVER DISTLER, M.D.
ZÜRICH, SWITZERLAND
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Chronic Pruritus of Unknown Origin (CPUO)
CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause and mostly affects the elderly. 3 The chronic and persistent itch is often described as being as debilitating as chronic pain, leading to reduced quality of life and affecting sleep patterns and mood. 3,7 There are currently no approved treatments for this condition. 3
Galderma's new phase II CPUO trial reinforces the company's commitment to exploring options for patients with chronic skin conditions that significantly impact quality of life. This randomized, double-blind, placebo-controlled proof-of-concept study will explore the pharmacokinetics and pharmacodynamics of nemolizumab in adults. Enrollment is expected to start in H2 2025 in the U.S., with completion anticipated in 2026. The study was designed in collaboration with a Steering Committee of world-leading dermatology experts, including the lead investigator Dr. Shawn Kwatra, M.D., PhD., Joseph W. Burnett Endowed Professor, Chairman of Dermatology, University of Maryland School of Medicine, U.S., and Dr. Sarina Elmariah, MD, PhD, MPH, Associate Professor and Dermatology Director at the Center for Itch and Neurosensory Disorders at the University of California in San Francisco, U.S.
The study is being conducted in the U.S. and more information about the study will be made available soon on the clinicaltrials.gov website.
'It is challenging to treat Chronic Pruritus of Unknown Origin as physicians have limited therapeutic options specifically targeting the underlying cause of itch. With the extensive data showing that IL-31 is a key driver of itch, I'm excited to explore whether nemolizumab's inhibition of IL-31 signaling might effectively reduce the intractable itch experienced by patients with Chronic Pruritus of Unknown Origin.'
DOCTOR SHAWN KWATRA, M.D., PHD
JOSEPH W. BURNETT ENDOWED PROFESSOR
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About nemolizumab
Nemolizumab was approved in August 2024 by the U.S. Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 5 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 5 To date, nemolizumab is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.
Nemolizumab 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. 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. 9,10
About Galderma
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.
References
1.
Jimenez SA, Mendoza FA, Piera-Velasquez S. A review of recent studies on the pathogenesis of Systemic Sclerosis: focus on fibrosis pathways. Front Immunol. 2025;16: 1551911. doi: 10.3389/fimmu.2025.1551911
2.
Truchetet ME, et al. Current Concepts on the Pathogenesis of Systemic Sclerosis. Clin Rev Allergy Immunol. 2021;64(3): 262–283. doi: 10.1007/s12016-021-08889-8
3.
Teresa J, et al. Therapeutics in chronic pruritus of unknown origin. Itch. 2023;8(1): pe64. doi: 10.1097/itx.0000000000000064
4.
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
5.
Nemluvio ® U.S. Prescribing Information. Available online. Accessed June 2025
6.
Nemluvio ® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed June 2025
7.
Andrade E, et al. Interventions for chronic pruritus of unknown origin. CDSR. 2020;1(1): CD013128. doi: 10.1002/14651858.CD013128.pub2
8.
Scleroderma & Systemic Sclerosis. National Health Service. Available online. Accessed June 2025
9.
Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed June 2025
10.
Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed June 2025
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The Company estimates peak annual sales potential of $1 billion, and priority review voucher eligibility if approved. Collaboration with DNDi for AN2-502998 clinical development in chronic Chagas disease In July 2025, the Company announced a collaboration with the Drugs for Neglected Diseases initiative (DNDi) to advance the clinical development of AN2's oral drug candidate AN2-502998. The collaboration provides AN2 with access to DNDi's extensive clinical trial network and expertise in Chagas disease to rapidly advance Phase 2 planning. The operational efficiencies generated from this collaboration will allow the Company to conduct a cost-efficient Phase 2 trial and preserve capital for other critical pipeline programs. Melioidosis Reported key findings from 200-patient observational study Melioidosis is a highly lethal bacterial infection caused by Burkholderia pseudomallei and is recognized by the Centers for Disease Control and Prevention (CDC) as a bioterrorism agent, underscoring its potential use as a biological weapon and its ability to cause severe disease in civilian and military populations. It is endemic in warm tropical regions of the world including areas of the Mississippi Gulf Coast, Puerto Rico and the U.S. Virgin Islands and is a Nationally Notifiable Disease, designated by the CDC for monitoring, controlling and preventing serious U.S. public health disease. In June, the Company announced key insights from its 200-patient observational study in acute melioidosis. Data from the study will inform and help optimize the design of a Phase 2 trial. The study, conducted in acute hospital settings, evaluated patients receiving standard of care antibiotics, IV meropenem or ceftazidime, tracking patients while in hospital and at 28 and 90 days. A death rate of nearly 40% (by day 90) was observed among confirmed melioidosis cases. Principal investigators observed that approximately 25% of screened patients died in the short period (~3-4 days) before a definitive diagnosis of infection was confirmed and enrollment completed. These deaths were not included in the topline mortality rate. These mortality findings highlight the serious impact of melioidosis - even with current standard of care treatment - the threat it poses as a potential bioterrorism agent, and the critical need for better treatment options. Discussions are underway with the U.S. government to fund Phase 2 development of epetraborole in acute melioidosis. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher (through the medical countermeasure pathway) and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S. Nontuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus Presented data demonstrating epetraborole's potent in vitro and in vivo activity in M. abscessus at the Nontuberculous Mycobacteria Conference at Colorado State University In May 2025, the Company presented a poster at the Nontuberculous Mycobacteria Conference at the Colorado State University highlighting epetraborole's potent in vivo activity against M. abscessus. The compound demonstrated an MIC90 that is 256-fold more potent than what was observed in the Phase 2/3 treatment-refractory NTM MAC study, reinforcing its potential as a candidate for this high-mortality condition. M. abscessus has an estimated all-cause 8-year mortality of 45% and current treatments involve burdensome IV therapies that lack FDA approval for the condition. The Company is evaluating the potential for a proof-of-concept study in M. abscessus and will provide an update on further development in the coming months. Boron Chemistry Pipeline Continuing to advance boron chemistry compounds in oncology The Company is pursuing a number of oncology targets where we believe boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole) as well as other important FDA-approved molecules including Velcade for oncology and multiple recent beta lactamase inhibitors to address multi-drug resistant bacteria. The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and have excellent oral pharmacokinetics. The Company anticipates advancing the first oncology compound into development later this year with potential clinical proof of concept data within the Company's current cash runway. The Company expects to advance its second oncology compound into development in the first half of 2026. Global Health Through non-dilutive funding, the Company continues its efforts to tackle global health diseases, including tuberculosis and malaria, with projects that are currently funded by a grant from the Gates Foundation. Selected Second Quarter Financial Results Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were $3.2 million, compared to $12.1 million for the same period during 2024 due to decreased clinical trial expenses, chemistry manufacturing and controls expenses, personnel-related expenses, consulting and outside services and other expenses, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities in August 2024, partially offset by increases in preclinical and research studies and expenses related to start-up activities of the Phase 1 trial in Chagas disease. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2025 were $4.0 million, compared to $3.7 million for the same period during 2024 due to increased professional and outside services expenses. Interest Income: Interest income for the second quarter of 2025 was $0.8 million, compared to $1.4 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024. Net loss: Net loss for the second quarter of 2025 was $6.5 million, compared to $14.4 million for the same period during 2024. Cash Position: The Company had cash, cash equivalents and investments of $71.2 million at June 30, 2025. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2028 under the current operating plan. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with programs focused on targets in oncology and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes. For more information, please visit our website at Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential and competitive advantage of the Company's boron chemistry platform; high-impact nature of the Company's clinical programs; the Company's approach to capital allocation and the availability of and plans to use non-dilutive funding, including the possibility that the U.S. government will not fund the Phase 2 and other future melioidosis trials; expectations regarding the Company's clinical trials, including initiation, enrollment, conduct and the timing of data and related announcements; the ability of non-human primate models to de-risk translation to human efficacy; market and sales potential; priority review voucher eligibility and registrational pathways; cash runway; continued global health programs; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2's ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2's clinical trials; disruptions at the FDA and other government agencies caused by funding shortages, staff reductions and statutory, regulatory and policy changes; AN2's ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results, the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidates; the significant uncertainty associated with AN2's product candidates ever receiving any regulatory approvals; continued government funding of AN2's development program for melioidosis; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading 'Risk Factors' in AN2's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2's website at and on the SEC's website at Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) June 30, 2025 (unaudited) December 31, 2024 Assets Current assets: Cash and cash equivalents $ 18,220 $ 21,351 Short-term investments 44,696 62,267 Prepaid expenses and other current assets 4,608 2,644 Long-term investments 8,301 5,021 Other assets, long-term — 804 Total assets $ 75,825 $ 92,087 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 2,113 $ 3,317 Other current liabilities 4,870 6,921 Total liabilities 6,983 10,238 Stockholders' equity 68,842 81,849 Total liabilities and stockholders' equity $ 75,825 $ 92,087 Expand
