DLQI

Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis

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일요일, 3월 10, 2024
Health, Medical Devices, Other Health, Clinical Trials, Research, Science, Biotechnology, Dermatology Life Quality Index, Atopic dermatitis, Prurigo nodularis, Nemolizumab, Patient, Sleep, American Academy, Quality of life, European Medicines Agency, Skin, AAD, FDA, DLQI, IGA, Food, 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.

ACELYRIN, INC. Announces Long-term 32-Week Data from the Phase 2b Trial of Izokibep in Hidradenitis Suppurativa Demonstrating Sustained Responses and Deepening Clinical Benefit - Improving Quality of Life for Patients

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월요일, 3월 11, 2024
Psoriatic arthritis, INC, Doctor of Philosophy, LOS, MD, SLRN, FDA, Quality of life, Pain, Infection, DLQI, Suicidal ideation, Abscess, Risk, Behavior, Safety, Hidradenitis suppurativa, Fungus, Patient, Medicine, IL-17A

LOS ANGELES, March 11, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa (HS). These data demonstrated no evidence of increased safety liability with longer-term treatment and increased duration of therapy was associated with further clinical improvements over time.

Key Points: 
  • (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa (HS).
  • These data demonstrated no evidence of increased safety liability with longer-term treatment and increased duration of therapy was associated with further clinical improvements over time.
  • “The magnitude and depth of responses for signs and symptoms of Hidradenitis Suppurativa in this long-term study are consistent with izokibep’s mechanism of action.
  • A confirmatory phase 3 trial of approximately 400 patients is planned to address guidance on size of safety database given the FDA no longer considers moderate-to-severe HS an orphan disease.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

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월요일, 2월 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

Dermavant to Present New ADORING Data Including Treatment of Patients with Skin of Color from Phase 3 Trials of VTAMA® (tapinarof) Cream, 1% in Adults and Children 2 Years of Age and Older with Atopic Dermatitis at the 2024 AAD Annual Meeting

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금요일, 3월 1, 2024
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Cream, LTS, Pros, Therapy, Incidence, Week, Psoriasis, Dermatology, Headache, Political moderate, Atopic dermatitis, Pain, Validation, Swelling, Itch, DLQI, Skin, Irritation, Folliculitis, Accepted, Common, QD, Stinger, Safety, Abstract, Patient, Rash, San Diego Convention Center, Nose, American Academy, 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.

AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024

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토요일, 3월 9, 2024
Pustulosis palmaris et plantaris, Psoriasis, CPU socket, Aes, Headache, Diarrhea, Amgen, Pain, Pediatrics, DLQI, Skin, Nausea, Vomiting, Queen's University, AMGN, AAD, Safety, University, FRCPC, University of Alberta, PASI, Dermatology Life Quality Index, Patient, PST, Scalp, Ageing, Abdominal pain, Poster, American Academy, 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.

LEO Pharma Announces Positive Phase 3 Head-to-head Data Results from DELTA FORCE Trial Comparing Delgocitinib Cream With Alitretinoin Capsules in Adults With Severe Chronic Hand Eczema (CHE)

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수요일, 1월 24, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, IGA, Hope, Delgocitinib, Patient, DLQI, CHE, Alitretinoin, Aes, Safety, Dermatology Life Quality Index, LEO, Leo Pharma, Quality of life (healthcare), Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.
  • Delgocitinib cream achieved the primary outcome measure of the trial by demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules.
  • Furthermore, patients receiving delgocitinib cream had a lower number of treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules.
  • Detailed results from DELTA FORCE are planned to be submitted for scientific presentation and publication at a later date.

LEO Pharma Presents Data at 2024 Winter Clinical and Maui Derm Conferences

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금요일, 1월 12, 2024
Pharmaceutical, Health, Clinical Trials, Ageing, Itch, Patient, DLQI, Sleep, CHE, Disease, Conference, Safety, Dermatology Life Quality Index, Atopic dermatitis, LEO, Leo Pharma, Catalog, Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of investigational delgocitinib cream and Adbry® data across 10 posters at the upcoming Winter Clinical and Maui Derm conferences this month.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of investigational delgocitinib cream and Adbry® data across 10 posters at the upcoming Winter Clinical and Maui Derm conferences this month.
  • The 2024 Winter Clinical Conference will take place Jan. 12-17 in Honolulu, Hawaii, while Maui Derm is being held from Jan. 22-26 in Maui, Hawaii.
  • LEO Pharma is currently developing delgocitinib cream for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults.
  • Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials.

Celldex Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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목요일, 11월 2, 2023
CSU, DLQI, Prurigo, Science, Survival, WCI, KIT, Research, Dermatology Life Quality Index, PN, Contingency, Congress, G&A, Work, B cell, PD-1, Cell, R, Quality of life, European Academy of Management, SD, Prurigo nodularis, Myelocyte, Disease, UCT, Eosinophilic esophagitis, Allergy, Georgia World Congress Center, ILT4, Therapy, Patient, Rockefeller University, SCF, Hypersensitivity, D, Pharmaceutical industry, Vaccine, Rare-earth element, Cryptocurrency, Dermatology

HAMPTON, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • - Phase 2 CSU enrollment complete; topline data by YE 2023 -
    HAMPTON, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity.
  • In July 2023, Celldex announced that enrollment to the CSU study (n=208) had been completed and that topline data is anticipated by the end of 2023.
  • Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2023 were $235.3 million compared to $252.7 million as of June 30, 2023.

Dermavant Presents Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Intertriginous Plaque Psoriasis in Adults at 43rd Annual Fall Clinical Dermatology Conference

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금요일, 10월 20, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Week, Patient, IPSO, FDA, Psoriasis, Rash, Headache, LTS, Ageing, Incidence, Folliculitis, Plaque, Quality of life (healthcare), Therapy, PGA, JD, Itch, Safety, Conference, Global Assessment of Functioning, Eyelid, Quality of life, Dermatology Life Quality Index, Groin, Disease, Prescription, Common, Stinger, Swelling, Irritation, Body surface area, Pain, Nose, Pharmaceutical industry, Medical imaging, Vaccine, Birth control, DLQI, Dermatology, MD

Intertriginous plaque psoriasis, also known as inverse psoriasis, affects approximately 20%–30% of individuals who have plaque psoriasis.

Key Points: 
  • Intertriginous plaque psoriasis, also known as inverse psoriasis, affects approximately 20%–30% of individuals who have plaque psoriasis.
  • The treatment for plaque psoriasis in intertriginous areas is specifically challenging, because these sensitive areas are more prone to potential adverse effects from existing steroidal-topical treatments.
  • DMVT-505-4001 (NCT05680740) was a Phase 4, open-label multi-center study that evaluated the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous plaque psoriasis (iPsO).
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa

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일요일, 10월 15, 2023
III, PPT, Pain, Professor, Hidradenitis, Quality of life, European Academies' Science Advisory Council, Pharmacokinetics, Doctor of Philosophy, MS, Journal of the European Academy of Dermatology and Venereology, Education, DLQI, Data, Venereology, Safety, Psoriasis, Hidradenitis suppurativa, Moonlake, Disease, FDA, Adalimumab, Webcast, Immunology, Maintenance, Abscess, I&I, Master of Education, MIRA, PGI, Pennsylvania State University, Patient, HS, Pharmaceutical industry, Perfume, Birth control, Dermatology, MD, Inflammation

We have consistently observed best-in-class clinical activity with our Nanobody®sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.

Key Points: 
  • We have consistently observed best-in-class clinical activity with our Nanobody®sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.
  • In June we elevated the bar for clinical response to HiSCR75 as the primary endpoint.
  • The MIRA trial set a landmark milestone as the first placebo-controlled randomized trial in HS to use Hidradenitis Suppurative Clinical Response 75 (HiSCR75) as the primary endpoint.
  • The 24-week results show that ongoing treatment with sonelokimab 120mg and 240mg dosed Q4W, further increased HiSCR75 response rates compared to week 12.