Latest news with #atopicDermatitis
Associated Press
07-07-2025
- Business
- Associated Press
Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis
APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including71.0%decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposureswith readout accelerated and now anticipated mid-2026, enabling planned Phase 3 initiation in 2026 APEX Part A testing potentially best in class 3- or 6-month maintenance dosing with 52-week readout anticipated 1H 2026 APG777 was well tolerated with a favorable safety profile consistent with other agents in class First patient dosed in APG279 (IL-13 + OX40L) Phase 1b head-to-head trial versus DUPIXENT with readout expected in 2H 2026 Management will host a conference call today at 8:00 a.m. ET SAN FRANCISCO and BOSTON, July 07, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, today announced positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD). 'With two out of every three patients treated with APG777 achieving EASI-75 response at Week 16 in the Phase 2 APEX Part A trial, APG777 demonstrated the highest EASI-75 response rate both on a topline and placebo-adjusted basis for any biologic in a global study to date, reinforcing its potential best-in-class profile for patients with moderate-to-severe atopic dermatitis,' said Michael Henderson, M.D., Chief Executive Officer of Apogee. 'APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing — benefitting patients, providers, and payers. Today's results bring us closer to that vision, and we believe further de-risks APG777's path to approval. In addition, I am excited for our two upcoming readouts to potentially even further improve on efficacy results — the accelerated APEX Part B testing higher exposures that is now expected to readout mid-2026, and the ongoing APG279 (IL-13 + OX40L) head-to-head trial against DUPIXENT expected to readout in the second half of 2026.' 'Today's results from APEX Part A demonstrate strong efficacy results across all key endpoints,' said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. 'In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX Part B. Combined with a favorable safety profile, these findings reinforce APG777's potential to deliver meaningful and durable benefit to patients while significantly reducing dosing frequency compared with existing agents. On behalf of the entire Apogee team, I'd like to extend our gratitude to the patients and physicians for their support in the successful execution of this important trial.' APEX Phase 2 Part A Key 16-Week Results The Phase 2 APEX clinical trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12. Patients benefiting from treatment continued maintenance dosing, evaluating 3- or 6-month dosing of APG777. The primary endpoint of Part A is mean percentage change in Eczema Area Severity Index (EASI) score from baseline at Week 16. Secondary endpoints include EASI-75, EASI-90, Validated Investigator Global Assessment (IGA) 0/1 and Itch Numeric Rating Scale (NRS) at Week 16. Initial 16-week findings from APEX Part A include efficacy results, which compare favorably versus standard of care across endpoints as well as rapid onset of itch relief and lesion reduction, and a favorable safety profile consistent with its class: 'The Phase 2 Part A results are exciting, with APG777 demonstrating promising efficacy results from only four injection days over the initial 16-week induction period,' said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. 'Despite meaningful advances in atopic dermatitis treatment, there remains a significant unmet need to reduce the injection burden for patients while continuing to improve patient outcomes. I look forward to seeing the first half-life extended antibody in AD progress and I am excited about Apogee's studies that are bringing this therapy closer to patients.' APEX Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo. Part B continues to enroll participants with readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026. Webcast Details Apogee Therapeutics' live webcast of the Phase 2 APEX Part A results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company's website at A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic Esophagitis (EoE) and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the Company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the Company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Forward Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future product candidates and programs; the expected timing of and results from its clinical trials, including 52-week maintenance data from Part A and the initial readout from Part B of its Phase 2 trial of APG777 in AD and initial readout from its Phase 1b trial of APG279 in AD; its planned clinical trial designs; its plans for current and future clinical trials, including the timing of initiation of a Phase 3 trial of APG777 in AD and potential path to regulatory approval; the potential clinical benefit and half-life, PK profile, dosing regimen, and treatment outcomes of APG777 and APG279; and its planned business strategies. Words such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'develop,' 'plan' or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee's filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the Company's control and subject to change. Actual or final results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Apogee's preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee's clinical trials; the unpredictable relationship between preclinical study results and clinical trial results, including across different phases of clinical trials; the accuracy of cross-trial comparisons against products in the same class; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, and subsequent disclosure documents Apogee has filed and may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB Media [email protected]
Medscape
03-07-2025
- Health
- Medscape
Pimecrolimus Repairs Steroid-Induced Skin Damage in AD
TOPLINE: Intermittent treatment with pimecrolimus 1% cream for 1 year was effective in reversing topical corticosteroid-induced skin damage in patients with atopic dermatitis. Pimecrolimus reduced skin damage by 30.5% on the face and by 38.6% on cubital areas, with skin thickness increases of 64.4% and 19.9%, respectively. METHODOLOGY: Researchers conducted a 12-month, single-group phase 4 study involving 41 adult patients with mild-to-moderate atopic dermatitis and clinically evident skin atrophy due to long-term corticosteroid use on the face and cubital areas. Participants received intermittent treatment with pimecrolimus 1% cream at the first signs of disease until lesions cleared, with prednicarbate 0.25% cream as a rescue medication for major flares. The mean duration of treatment was 201 ± 106 days. The primary endpoint was the decrease in the Dermatophot score from baseline to the end of the study as a measure of the reconstitution of corticosteroid-damaged skin being treated with pimecrolimus cream. TAKEAWAY: The Dermatophot score improved significantly from baseline — by 30.5% (95% CI, 20.8%-40.1%; P < .0001) on the face and 38.6% (95% CI, 28.2%-49.0%; P < .0001) on the cubital areas. Ultrasound measurements showed a 64.4% increase in facial skin thickness (P = .002) and a 19.9% increase in cubital area skin thickness (P < .02). At week 48, treatment success rates were 58.9% for facial lesions, 61.8% for cubital lesions, and 50.0% for whole-body lesions. Among subgroups defined by rescue medication use (> 33% vs ≤ 33% of the study period), those with lower exposure — using rescue medication for ≤ 33% of the study period — achieved numerically greater improvements in the Dermatophot score. Five patients experienced a total of six serious adverse events, none of which were considered related to the drug. IN PRACTICE: "In conclusion, this study demonstrated that long-term treatment with pimecrolimus 1% cream can lead to reconstitution of corticosteroid-damaged skin with favourable disease control," the authors wrote. SOURCE: The study was led by Diamant Thaçi, MD, Institute and Comprehensive Center for Inflammation Medicine, University of Luebeck, Luebeck, Germany. It was published online on June 20, 2025, in the Journal of Dermatological Treatment. LIMITATIONS: The study did not include a control group receiving standard therapy. The researchers noted that without a randomized double-blind design, they could not definitively determine whether disease control with pimecrolimus treatment enabled self-healing of skin atrophy through steroid reduction or whether pimecrolimus itself actively improved skin atrophy through pharmacologic effects. Patients with severe atrophy (Dermatophot score > 6) were not included as reconstitution of damaged skin was expected to be difficult in such cases. DISCLOSURES: The study was funded by Novartis Pharma Germany. One author reported being a former employee of Novartis Pharma Germany. Some authors reported receiving honoraria or grants, serving on advisory boards, or having other ties with various sources. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
27-06-2025
- Health
- Medscape
Pollution, Weather Linked to Atopic Dermatitis
TOPLINE: In a meta-analysis of 42 studies, exposure to air pollutants and high temperatures was associated with higher risk for clinic visits and worsened symptoms in adults with atopic dermatitis. METHODOLOGY: Researchers conducted a meta-analysis and systematic review of 42 studies from 14 countries between 1985 and 2024. They included cohort, case-control, and cross-sectional studies that examined associations between environmental exposures and atopic dermatitis outcomes in adults. Researchers assessed exposure to ambient air pollutants: Nitrogen dioxide (NO 2 ), sulfur dioxide (SO 2 ), particulate matter with a diameter of 10 µm or less (PM 10 ), PM with a diameter of 2.5 µm or less (PM 2.5 ), carbon dioxide (CO 2 ), ozone (O 3 ), temperature, precipitation, sunlight or solar radiation, humidity, secondhand smoke, seasonal variations, and pollution from traffic or industrial sources. TAKEAWAY: Outpatient clinic visits for atopic dermatitis increased with every 10-µg/m 3 increase in PM 10 (risk ratio [RR], 1.008; 95% CI, 1.003-1.012; high certainty evidence) and SO 2 (RR, 1.029; 95% CI, 1.020-1.039; high certainty evidence). increase in PM (risk ratio [RR], 1.008; 95% CI, 1.003-1.012; high certainty evidence) and SO (RR, 1.029; 95% CI, 1.020-1.039; high certainty evidence). High temperatures were also associated with moderate (OR, 2.39; 95%CI, 1.40-4.09) and severe atopic dermatitis (OR, 3.91; 95% CI, 2.20-6.96). Higher precipitation and humidity levels demonstrated probable associations with increased atopic dermatitis severity. Secondhand smoking exposure and traffic-related pollution showed probable associations with increased atopic dermatitis prevalence. IN PRACTICE: 'Increased air pollution and other environmental factors were associated with increased prevalence and activity of atopic dermatitis,' the authors wrote. These findings, they added, 'have direct public health implications, adding to the impetus to decrease pollution and mitigate climate change worldwide.' SOURCE: The study was led by Megan Park, University of Toronto, Toronto, Ontario, Canada, and was published online on June 25 in JAMA Dermatology. LIMITATIONS: Limitations included heterogeneity in air pollutant measurement and reporting across regions. Only moderate-to-severe disease was likely captured. Socioeconomic data was not available and inconsistent lag reporting restricted analysis of short-term and long-term effects. DISCLOSURES: The authors did not disclose any funding source. One author reported receiving consulting fees and research grants from the British Journal of Dermatology, American Academy of Dermatology, Canadian Dermatology Today, National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, Canadian Institutes for Health Research, National Institutes of Health, and Physicians Services Incorporated Foundation. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
25-06-2025
- Health
- Medscape
FDA Extends Ruxolitinib Cream Review Period for Pediatric AD
The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for the topical formulation of the JAK inhibitor ruxolitinib as a treatment of atopic dermatitis (AD) in children aged 2-11 years, according to a press release from the manufacturer. The new PDUFA date is September 19, 2025, according to the company, Incyte. The review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) was extended to provide time for the FDA to review additional data on chemistry, manufacturing, and controls related to the 0.75% formulation, according to the press release. Topical ruxolitinib cream (1.5%) is approved by the FDA for short-term and noncontinuous chronic treatment of mild-to-moderate AD in patients aged 12 years or older who are not immunocompromised for whom topical prescription therapies are contraindicated or insufficient for disease control. Topical ruxolitinib also is approved for nonsegmental vitiligo in patients aged 12 years or older in the US. The sNDA for the AD indication in younger children is based on data from a phase 3 study known as TRuE-AD3, in which children aged 2-12 years with mild-to-moderate AD were randomly assigned to 0.75% or 1.5% ruxolitinib cream or a vehicle. In the study, significantly more children treated with ruxolitinib compared with placebo met the primary endpoint of treatment success based on the Investigator's Global Assessment-Treatment Success measure. Treatment was well-tolerated overall, consistent with previous studies of topical ruxolitinib, with no new safety signals noted. The most common treatment-related adverse event in ruxolitinib-treated patients was application site pain, but no treatment-related events prompted discontinuation, according to the press release. The TRuE-AD3 study was funded by Incyte.
Medscape
13-06-2025
- Health
- Medscape
What Role Does Diet Play in Managing Atopic Dermatitis?
Eliminating 'problematic' foods or ingredients from the diet is not a sensible measure to apply across all patients with atopic dermatitis (AD), although it may be beneficial for a subset of patients with moderate-to-severe disease who also have documented food allergies. This point was emphasized in several presentations at The World Congress of Pediatric Dermatology (WCPD) 2025 Annual Meeting, held recently in Buenos Aires, Argentina. 'There is currently no role for routine elimination diets in all patients with AD,' said Sandipan Dhar, MD, professor and head of the Department of Pediatric Dermatology at the Institute of Child Health in Kolkata, India, and current vice president of the International Society of Pediatric Dermatology. Dhar noted that when you google the words 'diet' and 'eczema,' about half of the results come from self-proclaimed 'experts,' 30% from educational websites, and 20% from promotional sites. Among the top 10 results, 80% recommend avoiding milk or dairy, and 50% suggest avoiding soy, wheat, and gluten. However, only 3%-10% of patients with AD also have food allergies, though that proportion can rise to one third among individuals with moderate-to-severe disease, Dhar explained. 'Remember: Dietary restriction makes no sense in pediatric or adult patients with mild AD.' Although there are no clear diagnostic criteria, young children with severe AD are more likely to have food allergies, said Dhar. A 2015 population-based cohort study of more than 4000 infants found that those with AD had a sixfold increased risk for food allergy to cow's milk, egg, or peanuts. Effectiveness of Elimination Diets Dhar stated that a review of the literature shows 'mixed results' regarding the usefulness of elimination diets in AD, with few randomized, double-blind studies published in the past 20 years supporting a role for food allergy in clinical manifestations of the disease. A 2008 Cochrane review concluded that there is 'little evidence' supporting the use of exclusion diets in unselected individuals with AD. In 2009, Dhar led an open-label, uncontrolled pilot study in a selected group of 100 infants and children with severe AD. Participants were asked to strictly avoid milk and dairy products, all types of nuts, egg, marine fish, shrimp, eggplant, and soy for 3 weeks. The study found a statistically significant reduction in disease severity scores. However, Dhar clarified that he now critiques his own study ('this is how science progresses') and that the concept of strict food avoidance has evolved. In the past decade, numerous studies have shown that delaying the introduction of foods such as milk, egg, wheat, and peanuts during infancy actually increases the risk of developing allergies to those foods. In the landmark 2015 LEAP trial from the UK, early introduction of peanuts starting at 4 months of age in infants aged 4-11 months with severe AD and egg allergy significantly reduced the risk for peanut allergy compared to those who avoided peanuts until age 5. María Fernanda Greco, MD, a panelist at the congress and head of Pediatric and Adolescent Dermatology at the British Hospital in Buenos Aires, Argentina, agreed that there is no single dietary approach suitable for all patients with AD. However, she emphasized that 'there is growing interest in the role of the gut microbiome in skin health' and suggested that enhancing the gut barrier through diets that promote intestinal health, as well as probiotic supplementation (eg, Lactobacillus and Bifidobacterium found in yogurt and fermented foods) or prebiotics (found in garlic, onions, and bananas), may help improve the skin barrier and reduce disease severity in the short term. For example, a 2021 randomized Polish study found that a probiotic preparation containing three strains ( Lactobacillus rhamnosus ŁOCK 0900, L rhamnosus ŁOCK 0908, and L casei ŁOCK 0918) increased the likelihood of improvement by sixfold over 3 months in children younger than 2 years with AD and cow's milk protein allergy. However, the benefits did not persist after 9 months. Supplementing with omega-3 polyunsaturated fatty acids may also help modulate inflammatory responses and improve symptoms, she added. 'It's difficult to take a definitive stance [on the role of diet in AD], but I believe that with each patient, we need to assess whether they might benefit from supplementation, food avoidance, or allergy testing,' Greco concluded. Dhar closed the session by emphasizing that until future studies clarify the relationship between food allergies, AD, and the immune pathways that regulate tolerance and immediate hypersensitivity, clinical decisions about elimination diets should be based on reflective, cautious interpretation of the available evidence. And if an elimination diet is pursued, it should be personalized 'based on the patient's needs, the severity of eczema, and documented correlations between dietary intake and skin flares or food allergies — without neglecting nutritional balance,' he concluded. Dhar disclosed advisory or thought-leader roles with some pharmaceutical companies, though his presentation did not reference any commercial products. Greco declared having no relevant financial conflicts of interest.
