Latest news with #plaquePsoriasis
Medscape
22-05-2025
- Health
- Medscape
FDA Approves Roflumilast Foam for Scalp, Body Psoriasis
The foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast has been approved by the US Food and Drug Administration (FDA) for treating plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older, according to an announcement from the manufacturer Arcutis Biotherapeutics. The 0.3% foam formulation of roflumilast (Zoryve) was previously approved for the treatment of seborrheic dermatitis in adults and children aged 9 years and older. The company has since then filed a supplemental New Drug Application with the FDA in September 2024. A 0.3% cream version is approved as a topical treatment for plaque psoriasis in adults and children aged 6 years and older. And the 0.15% cream formulation of roflumilast is approved for treatment of mild-to-moderate atopic dermatitis for the same population. Approval is based on data from phase 2b and 3 studies. In the pivotal phase 3 ARRECTOR study recently published in JAMA Dermatology , 432 patients with scalp and body psoriasis aged 12 years and older were randomized to once-daily application of 0.3% roflumilast foam or a vehicle for 8 weeks. Medscape also reported the findings. Significantly more patients in the roflumilast group vs the vehicle group achieved the primary endpoints of Scalp-Investigator Global Assessment (S-IGA) and Body-IGA (B-IGA) success — defined as clear or almost clear — plus two or more grades of improvement from baseline after 8 weeks of treatment (66.4% vs 27.8% for S-IGA; 45.5% vs 20.1% for B-IGA; P < .001 for both). In addition, significantly more patients who received roflumilast achieved a clinically significant reduction of itch (defined as a change of ≥ 4 points from baseline on the Scalp Itch-Numeric Rating Scale) compared with those on the vehicle after 8 weeks (65.3% vs 30.3%). Significantly more roflumilast-treated patients with baseline scalp itch also showed significant improvement compared with placebo patients after 2 weeks and 4 weeks of treatment (25.2% vs 8.0%; 46.2% vs 16.8%, respectively; P < .001 for all). Body itch scores also improved significantly in the roflumilast patients compared to those in the vehicle group. Rates of adverse events were similar and low in both treatment and placebo groups, as were treatment-emergent adverse events and rates of discontinuation because of adverse events, the researchers noted. The most common adverse events reported among patients treated with 0.3% roflumilast foam were headache (1.1%), nausea (1.3%), and nasopharyngitis (1.5%), according to the company's press release. It is contraindicated in patients with moderate-to-severe liver impairment (Child-Pugh B or C).
National Post
22-05-2025
- Health
- National Post
Rubedo Life Sciences Announces First Patient Dosed with Lead Drug Candidate RLS-1496, the First GPX4 Modulator Targeting Pathologic Senescent Cells To Enter Phase 1 Clinical Trial
Article content First patient dosed with topical RLS-1496 in clinical trial will assess the safety and clinical effects of single and multiple doses to treat adults with mild to moderate and stable plaque psoriasis, skin aging, and additional inflammatory diseases, including atopic dermatitis, vitiligo, rosacea, alopecia areata, and scleroderma 1 Article content Article content RLS-1496 – a first-in-class disease-altering GPX4 modulator selectively targeting pathological senescent cells that drive inflammaging and chronic degenerative diseases and conditions associated with the biological aging process 2 – is the first GPX4 modulator to enter a human clinical trial, ahead of many leading biopharmaceutical companies evaluating the same target Article content RLS-1496 uses Rubedo's proprietary, AI-driven drug discovery platform ALEMBIC™, which identifies targets within pathologic senescent cells and develops selective cellular rejuvenation medicines for these targets Article content SAN FRANCISCO — Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on discovering and rapidly developing selective cellular rejuvenation medicines targeting aging cells, today announced that the first patient has been dosed with lead drug candidate RLS-1496 in the company's single-center, ascending-dose, randomized, double-blind, vehicle-controlled trial. The study marks the first time a GPX4 (glutathione peroxidase) modulator has entered Phase 1 clinical trial and is designed to assess the safety, tolerability, clinical effects, plasma bioavailability, and pharmacodynamics of topical RLS-1496 in male or female patients 18 years or older with mild to moderate and stable plaque psoriasis. These subjects' aging skin will also be treated and assessed to see if RLS-1496 can improve biomarkers of aging and reverse the skin age or biological clock. Based on the results of this study, the trial will potentially expand to additional inflammatory skin conditions and autoimmune disorders, including but not limited to atopic dermatitis, vitiligo, rosacea, alopecia areata, and scleroderma. 3 A systemic formulation of RLS-1496 is planned to enter Phase 1 clinical trials in 2026. Article content 'We are excited to reach this important milestone not only for our lead candidate RLS-1496 but also for the advancement of longevity science,' said Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD, FACMS. 'As the first company to treat patients with a GPX4 modulator targeting senescent cells in a data-rich Phase 1 clinical trial, we look forward to assessing its potential disease-altering effects on inflammatory skin conditions and skin aging, driving our pipeline forward in line with our goal of making a meaningful impact on age-related diseases and conditions, such as obesity and pain.' Article content Rubedo Chief Scientific Officer Marco Quarta, PhD, said, 'For the last decade, longevity scientists have been working to develop a compound ready for human trials that safely and effectively targets pathologic senescent cells. We are proud that our team developed RLS-1496 into a topical drug candidate in less than three years from initiation – two times faster than the industry average 1 via ALEMBIC™, our proprietary AI-driven drug discovery platform with SenTeCh™ chemistry technology. The other candidates in our pipeline are following similar expedited timelines, including systemic RLS-1496, which is aimed to begin Phase 1 clinical trials in 2026.' Article content The design of the clinical trial is to assess primary and secondary objectives of safety and clinical effects of single and multiple doses of topical RLS-1496, compared to vehicle (control), in patients with mild to moderate stable plaque psoriasis. A key secondary objective is to evaluate the effects of RLS-1496 on target psoriasis lesions using a common measure of psoriasis severity, the modified Investigator's Global Assessment (mIGA), to evaluate improvement. The trial will be conducted at a single center in The Netherlands with approximately 24 enrolled patients, starting with single dose application followed by a multidose protocol. Article content The design of the trial was developed with key insights provided by Rubedo's Clinical Advisory Board (CAB), which is led by Rubedo Chief Medical Officer and dermatologist Mary Spellman, MD. The CAB includes the following leading dermatologists who are both practicing clinicians and researchers, and are supporting Rubedo as strategic and scientific consultants and advisors: Article content Mark Lebwohl, MD, Professor & Chairman Emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, NY Ted Lain, MD, MBA, Executive Director & Principal Investigator, Austin Institute for Clinical Research; CMO, Sanova Dermatology, Austin, TX Zoe Draelos, MD, Founder, Dermatology Consulting Services, High Point, NC Chris Griffiths, OBE MD FRCP, Emeritus Professor of Dermatology, University of Manchester; Adjunct Professor of Dermatology, Kings College of London, London, England Article content Dr. Lebwohl said, 'As clinicians, we are excited about the potential use of RLS-1496 as a topical treatment for psoriasis, other chronic inflammatory skin conditions, and skin aging itself. As researchers, we are intrigued by RLS-1496 as a potential first-in-class GPX4 modulator that was designed to selectively target inflammaging pathologic senescent cells and surrounding tissues. This is a very important milestone in longevity science, and we are thrilled to be working with the Rubedo team to drive this science forward.' Article content Rubedo's lead candidate RLS-1496 is a potential first-in-class, disease-altering GPX4 modulator selectively targeting pathologic senescent 'zombie' cells that drive chronic degenerative diseases and conditions associated with biological aging processes. These include immunology and inflammation (I&I), dermatology and skin aging, metabolic syndrome (obesity, diabetes, liver fibrosis), sarcopenia, and neurodegenerative disease. Article content GPX4 is a major antioxidant-regulating enzyme that protects cells and tissues from free radical damage and is essential for cell survival. In contrast, GPX4 deficiency is associated with regulated cell death (RCD), especially ferroptosis. In certain pathologic cells, aging is associated with an imbalance in GPX4. By modulating GPX4 to selectively encourage cell death in ferroptosis-sensitive senescent zombie cells, RLS-1496 may be able to clear these cells to not only fight disease, but also support healthy cells to function properly. Article content About Rubedo Life Sciences Article content Rubedo Life Sciences is a clinical-stage biotech developing a broad portfolio of innovative selective cellular rejuvenation medicines targeting aging cells that drive chronic age-related diseases. Our proprietary AI-driven ALEMBIC™ drug discovery platform is developing novel first-in-class small molecules to selectively target pathologic and senescent cells, which play a key role in the progression of pulmonary, dermatological, oncological, neurodegenerative, fibrotic, and other chronic disorders. Our lead drug candidate – RLS-1496, a potential first-in-class disease-altering GPX4 modulator – is currently in Phase I clinical trials. The Rubedo leadership team is composed of industry leaders and early pioneers in chemistry, AI technology, longevity science, and life sciences, with expertise in drug development and commercialization from both large pharmaceutical and leading biotechnology companies. The company is headquartered in Sunnyvale, CA, USA, and has offices in Milan, Italy. For additional information, visit Article content Article content Article content Article content Article content Contacts Article content Article content Article content
