AAD

More than two-thirds of people with atopic dermatitis and skin of color experienced skin improvement in a first-of-its-kind lebrikizumab study

Retrieved on: 
Sunday, March 10, 2024
Diagnosis, Pigment, LLY, Weill Cornell Medicine, Atopic dermatitis, Health equity, Alaska Natives, Patient, Education, PDCA, Advocate, Diversity, Adherence, Immunology, Research, American Academy, Human, Weill Cornell Medical Center, Dermatitis, African, Skin, Safety, Lilly, Eli Lilly and Company, AAD, Health, IGA, Almirall, Pharmaceutical industry

In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief.

Key Points: 
  • In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief.
  • These late-breaking results from a Phase 3 study are being presented today at the American Academy of Dermatology (AAD) Annual Meeting.
  • "People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis and a lengthier timeframe to find appropriate treatment.
  • "With these initial results, Lilly is taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis."

Latest data of InnoCare's ICP-332 for the Treatment of Atopic Dermatitis Presented at LBA Session of 2024 AAD

Retrieved on: 
Wednesday, March 13, 2024
High, Safety, HKEX, AAD, IGA, Patient, TYK2, Trial of the century, NRS, American Academy, Pharmaceutical industry

75 eligible AD patients were randomized into three groups: once daily oral ICP-332 80 mg, once daily oral 120 mg, and placebo respectively.

Key Points: 
  • 75 eligible AD patients were randomized into three groups: once daily oral ICP-332 80 mg, once daily oral 120 mg, and placebo respectively.
  • ICP-332 demonstrated a rapid response, with the NRS score from baseline in the two treatment groups showing statistically significant improvement on day 2.
  • With the improvement of pruritus, the quality of life of subjects in the two treatment groups was significantly elevated.
  • The 2024 AAD Annual Meeting is held from March 8 to 12 in San Diego, California, USA.

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Therapy, SAN, Ulcerative colitis, Week, CDAI, B cell, Atopic dermatitis, BTLA, Q2, PD-1, Inflammation, Annual general meeting, AAD, UC, Idealized cognitive model, Rheumatoid arthritis, IGA, Patient, BDCA2, IND

“We will have a number of important events in 2024 including the top-line data readout of ANB032's Phase 2b trial in atopic dermatitis by year end,” adds Faga. “We also plan to move our third and fourth ICMs -- ANB033, our anti-CD122 antagonist, and ANB101 -- into the clinic this year, with IND filings planned for Q2 and H2, respectively.”

Key Points: 
  • “Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis.
  • The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
  • The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
  • Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.

Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting

Retrieved on: 
Monday, March 11, 2024
American Academy of Dermatology, Microbiota, Marketing, FDA, U.S. FDA, Skin, Forehead, Entrepreneurship, Risk, AAD, Safety, GI, Red, Rosacea, Minocycline, Patient, Clinical trial, Erythema, Vagina, Microbiology, American Academy

SCOTTSDALE, Ariz., March 11, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.

Key Points: 
  • The clinical trial also assessed the safety and tolerability of the treatment.
  • The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical.
  • Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study.
  • Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462 .

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024
Eosinophil, Fever, Week, Headache, OX40L, Conjunctivitis, Scleroderma, Teaching hospital, Atopic dermatitis, Upper respiratory tract infection, Part, Asthma, TARC, Conference, AAD, Safety, Biomarker, Part Two, Hidradenitis suppurativa, IGA, Patient, Inflammation, Chills, Moa, Serum, American Academy, Pharmaceutical industry

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Arcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting

Retrieved on: 
Sunday, March 10, 2024
Atopic dermatitis, SAN, AAD, Disease, Week, American Academy

In the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P

Key Points: 
  • In the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P
  • “For the pediatric patient population, tradeoffs between efficacy, tolerability, and safety are critical aspects of atopic dermatitis treatment decisions.
  • The data reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.
  • “Roflumilast cream 0.05% was also shown to be well-tolerated in young children as demonstrated by both investigator and patient-reported outcomes.

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

Retrieved on: 
Sunday, March 10, 2024
Psoriatic arthritis, ACR, Doctor of Philosophy, Adalimumab, Skin, American College, Webcast, Moonlake, HS, Patient, Psoriasis, VELA, MMSc, ARGO, MIRA, EDT, Physician, Inflammation, Safety, Prognosis, Clinical trial, Ankylosing spondylitis, TNF, IL-17A, MDA, American Academy, EMA, Medical college, FDA, Food, Steroid, Prevalence, AAD, Event, Joint, PASI, Hidradenitis suppurativa, PSA, PPP, Disease, Porokeratosis, Medicine, Pharmaceutical industry

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

New Research Reveals Genomic Profile of Seborrheic Dermatitis and Answers Key Questions on Immune Response and Skin Barrier Dysfunction

Retrieved on: 
Saturday, March 9, 2024
The Department, SAN, Immunodeficiency, Psoriasis, Doctor of Philosophy, Waldman, STAT1, IL22, MD, Mount Sinai Health System, Dermatitis, Atopic dermatitis, Biopsy, RNA-Seq, OASL, Rosacea, Laboratory, AAD, CXCL9, FA2H, Hospital, RNA, Immunology, IGA, Patient, Gene, PI3, Seborrhoeic dermatitis, Skin condition, Observational study, Skin, Research, Gene expression, American Academy, Vaccine

“We are excited to have successfully employed noninvasive tape-stripping techniques developed from studying these diseases to study an understudied and undertreated inflammatory skin disease, seborrheic dermatitis.

Key Points: 
  • “We are excited to have successfully employed noninvasive tape-stripping techniques developed from studying these diseases to study an understudied and undertreated inflammatory skin disease, seborrheic dermatitis.
  • These findings will help establish the groundwork for greater understanding of this very common condition.”
    “The pathophysiology of seborrheic dermatitis has been poorly understood.
  • In addition, the skin barrier disruption observed in seborrheic dermatitis has unique molecular underpinnings, primarily in the tight junction of the epithelial skin cells and lipid metabolism pathways.
  • These data demonstrate that seborrheic dermatitis is an immune disease with a uniquely polarized profile distinct from atopic dermatitis and plaque psoriasis.

Alumis Presents Positive Data from Phase 2 Clinical Trial of ESK-001, an Oral Allosteric TYK2 Inhibitor for the Treatment of Plaque Psoriasis, at AAD Annual Meeting

Retrieved on: 
Saturday, March 9, 2024
Well, SAN, Psoriasis, Quality of life, Hope, AAD, STRIDE, Safety, RNA, Patient, OLE, TYK2, Clinical trial, American Academy, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 09, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced the presentation of positive clinical data from a Phase 2 clinical trial of ESK-001, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate-to-severe plaque psoriasis. These data were presented during a late-breaking session at the American Academy of Dermatology (AAD) Annual Meeting being held March 8-12 in San Diego, California.

Key Points: 
  • These data were presented during a late-breaking session at the American Academy of Dermatology (AAD) Annual Meeting being held March 8-12 in San Diego, California.
  • The STRIDE trial enrolled 228 patients who were randomized to one of five ESK-001 dose cohorts, or placebo.
  • These data support the planned initiation of Phase 3 clinical trials of ESK-001 in moderate-to-severe plaque psoriasis in the second half of 2024.
  • “The Phase 2 clinical program was designed to evaluate the effect of different degrees of target inhibition on safety and clinical efficacy in psoriasis.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Saturday, March 9, 2024
EMA, Week, Psoriasis, Committee, SB5, Political moderate, Ustekinumab, Organon, FDA, Food, Samsung, BLA, Trial of the century, AAD, Safety, CHMP, Pharmacokinetics, Abstract, Biologics license application, American Academy, Novartis, Interchangeability

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results