Associated tags: Atopic dermatitis, Health, Pharmaceutical, Patient, Pharmaceutical industry, Research, Biotechnology, Clinical Trials, FDA, Safety, Science, Vaccine, AD, Dermatology, Dermatitis, Week, LEO, IGA, Leo Pharma, Disease
BURLINGAME, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of the Company’s randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The trial is expected to enroll 64 patients at 12 sites in the United States, with the potential for initial clinical data before year-end 2024.
Key Points:
- Atopic dermatitis is the first immune disease indication being studied in the clinic for soquelitinib, the Company’s selective ITK inhibitor
BURLINGAME, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of the Company’s randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
- The trial is expected to enroll 64 patients at 12 sites in the United States, with the potential for initial clinical data before year-end 2024.
- “The initiation of our Phase 1 atopic dermatitis trial is an important step towards unlocking the broad potential of ITK inhibition for immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus.
- In addition, the Company has evaluated soquelitinib in companion dogs with naturally occurring, refractory atopic dermatitis.
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Pharmaceutical industry Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.
Key Points:
- Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.
build and strengthen for these debilitating diseases, where symptoms
such as intense itch can put a significant burden on quality of life.
- response in prurigo nodularis and atopic dermatitis, respectively.”
69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator’s Global Assessment (IGA) score
Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).1
Results also reinforced nemolizumab’s rapid onset of action, with nemolizumab-naïve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week four, consistent with the continuous-nemolizumab cohort.
- Nemolizumab was also granted U.S. FDA Priority Review for prurigo nodularis.
- Further submissions to regulatory authorities in additional countries are planned in 2024.
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Pharmaceutical industry LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).
Key Points:
- LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).
- The findings are being shared via an e-poster at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1
The results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology.
- “The data presented for Adbry at AAD further builds upon an established, wide-ranging collection of clinical evidence that aims to improve the support for those living with moderate-to-severe AD,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.
- “This new analysis demonstrates the benefits of the long-term use of Adbry for adults who live with this chronic condition.”
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Pharmaceutical industry “Importantly, approximately 50% of patients who enrolled in the ADORING pivotal trials had skin of color, a particularly high representation in clinical trials.
Key Points:
- “Importantly, approximately 50% of patients who enrolled in the ADORING pivotal trials had skin of color, a particularly high representation in clinical trials.
- Secondary endpoints in the pivotal studies included the proportion of patients who achieved ≥75% improvement in the Eczema Area and Severity Index (EASI75).
- Baseline Demographics Across ADORING Pivotal Phase 3 Trials:
Approximately 50% of patients who enrolled had skin of color.
- New Data on VTAMA cream from ADORING 1 and ADORING 2 for the Treatment of AD in Patients with Skin of Color Presented at AAD 2024 – Primary and Secondary Endpoints:
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Pharmaceutical industry LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting.
Key Points:
- LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting.
- The event is being held from March 8th to 12th in San Diego, California.
- “Our growing body of clinical evidence reinforces our passion and commitment to advancing the standard of care in medical dermatology,” said Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer.
- I am proud that we can follow up on our 2023 AAD program with this level of critical data,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.
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Vaccine VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD).
Key Points:
- VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD).
- VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase 3 development program for AD.
- The following posters will be viewable onsite at the San Diego Convention Center.
- Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
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Pharmaceutical industry THOUSAND OAKS, Calif., March 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.
Key Points:
- These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.
- "These data reflect Amgen's commitment to exploring new ways to treat inflammatory skin disease," said Ponda Motsepe-Ditshego, vice president, Global Medical, at Amgen.
- Continued Otezla use resulted in sustained improvements in psoriasis severity and skin involvement in patients for up to one year.
- Findings will be presented as a late-breaking oral presentation on Saturday, March 9 at 9:20 a.m. PST.
Retrieved on:
Wednesday, February 14, 2024
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Pharmaceutical industry VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD.
Key Points:
- VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD.
- VTAMA cream, 1% data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older.
- On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults.
- Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
Retrieved on:
Wednesday, February 14, 2024
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Priority review This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.
Key Points:
- This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.
- Priority Review is granted for medicines that would significantly improve the treatment, diagnosis or prevention of serious conditions.
- The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.
- “The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life.
Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis.
Key Points:
- Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis.
- “These data demonstrate the rapid and reliable efficacy of roflumilast cream in atopic dermatitis with the majority of individuals achieving measurable improvement in EASI in as little as one week,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis.
- INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.
- Roflumilast Cream 0.15% in Patients With Atopic Dermatitis: Individual Patient EASI Responses: Pooled INTEGUMENT 1 and INTEGUMENT 2 Phase 3 Trials
