Moonlake

MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update

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화요일, 5월 7, 2024
Komodo, Psoriatic arthritis, VELA, FDA, American Academy, Porokeratosis, Psoriasis, HS, Skin, Rheumatology, MDA, Research, Partnership, Conference, PPP, MIRA, Joint, Bimekizumab, Patient, EMA, AAD, Inflammation, PASI, Moonlake, Dermatology, ARGO, Pharmaceutical industry

Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2024 is shaping up to be a strong year for MoonLake.

Key Points: 
  • Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2024 is shaping up to be a strong year for MoonLake.
  • Research and development expenses for the quarter ended March 31, 2024, were $13.0 million, compared to $8.1 million in the previous quarter.
  • The increase was primarily due to expenses incurred to initiate the new clinical trials.
  • General and administrative expenses for the quarter ended March 31, 2024 were $6.8 million, similar to the $6.9 million incurred in the previous quarter.

MoonLake Immunotherapeutics inks three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions 

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수요일, 4월 10, 2024
Komodo, Psoriatic arthritis, Arthropathy, Holocene, HS, Skin, Hidradenitis suppurativa, Partnership, Research, Literature, Entrepreneurship, Disease, Steroid, Patient, Inflammation, Marketing, Moonlake, Prevalence, Pharmaceutical industry

San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.

Key Points: 
  • San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.
  • Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision making across its clinical operations, medical, marketing, and market access teams.
  • Komodo’s data and technology applications will support MoonLake’s in-depth market research, clinical trial site selection, go-to-market strategies, and patient journey mapping – all aimed at accelerating the development of new treatment options and improving outcomes for patients with inflammatory skin and joint diseases.
  • Tino Anthamatten, VP Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors.

MoonLake Immunotherapeutics Inks Three-Year Technology Partnership With Komodo Health To Advance Research on Inflammatory Skin and Joint Conditions

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수요일, 4월 10, 2024
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Artificial Intelligence, Other Science, Other Technology, Research, Software, General Health, Health Technology, Science, Data Management, Komodo, Psoriatic arthritis, Arthropathy, Holocene, HS, Skin, Hidradenitis suppurativa, Marketing, Partnership, Literature, Entrepreneurship, Disease, Steroid, Patient, Inflammation, Multimedia, Moonlake, Prevalence, Pharmaceutical industry

MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.

Key Points: 
  • MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.
  • View the full release here: https://www.businesswire.com/news/home/20240410438883/en/
    Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision-making across its clinical operations, medical, marketing, and market access teams.
  • Tino Anthamatten, VP, Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors.
  • The real-world insights from Komodo helped validate a future HS market size projected to exceed $10B by 2035.

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

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일요일, 3월 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.

MoonLake Immunotherapeutics to present MIRA trial data of Nanobody® sonelokimab in hidradenitis suppurativa as a late breaker at the AAD Annual Meeting 2024

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월요일, 3월 4, 2024
MIRA, University College Dublin, Doctor of Philosophy, MD, Teaching hospital, Single-domain antibody, EST, Hidradenitis suppurativa, Inflammation, AAD, Safety, Patient, PST, Moonlake, Venereology, HS, American Academy, Pharmaceutical industry

Kristian Reich, MD, PhD, Chief Scientific Officer at MoonLake commented: “We are pleased that the 24-week data from our Phase 2 MIRA trial has been selected by the American Academy of Dermatology as an oral late-breaking presentation.

Key Points: 
  • Kristian Reich, MD, PhD, Chief Scientific Officer at MoonLake commented: “We are pleased that the 24-week data from our Phase 2 MIRA trial has been selected by the American Academy of Dermatology as an oral late-breaking presentation.
  • The presentation will be held on Sunday 10 March at 14:00 PST / 17:00 EST / 23:00 CET during the late breaking research session 2 (S050) in room 20B.
  • Key members of the MoonLake team, including the executive leadership team, will attend AAD.
  • This was followed by an announcement in October 2023, reporting from the trial at 24 weeks, further establishing sonelokimab as a highly promising and differentiated therapeutic solution for HS.

MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS)

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월요일, 2월 26, 2024
MIRA, Psoriatic arthritis, EMA, VELA, Physician, FDA, Food, SLK, BLA, Inflammation, Hidradenitis suppurativa, Patient, OLE, Moonlake, Biologics license application, Medical imaging

European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS).

Key Points: 
  • European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS).
  • The Phase 3 program, named VELA, is expected to enroll 800 patients and in combination with the data from Phase 2 MIRA trial will support both a Biologics License Application (BLA) and E.U.
  • We deeply appreciate the support from both agencies and continue to work swiftly to ramp up the Phase 3 program in HS, named VELA.
  • Moonlake will provide more information relating to the plans for both the HS and PsA programs during an upcoming R&D Day.

MoonLake Immunotherapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update

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화요일, 11월 14, 2023
IL-17A, Moonlake, Safety, MIRA, Psoriatic arthritis, Patient, Inflammation, Research, Calendar, HS, Conference, Antibody, Hidradenitis suppurativa, Skin, PASI, ARGO, Pharmaceutical industry, Security (finance), Vaccine

During the quarter and post period, MoonLake announced significant new positive clinical data from two global Phase 2 trials of sonelokimab: “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and “ARGO”, in active psoriatic arthritis (PsA).

Key Points: 
  • During the quarter and post period, MoonLake announced significant new positive clinical data from two global Phase 2 trials of sonelokimab: “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and “ARGO”, in active psoriatic arthritis (PsA).
  • The Nanobody’s® smaller size versus traditional antibodies and its albumin-binding domain provide an opportunity for further efficacy.
  • Research and development expenses for the quarter ended September 30, 2023, were $7.6 million, compared to $8.7 million in the previous quarter.
  • General and administrative expenses for the quarter ended September 30, 2023, were $5.4 million, compared to $4.5 million in the previous quarter.

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.

Phase 2 MIRA primary analysis trial results (12-week) for MoonLake’s Nanobody® sonelokimab in hidradenitis suppurativa to be presented at a late-breaking session at the European Academy of Dermatology and Venereology Congress

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수요일, 10월 4, 2023
Psoriatic arthritis, University College Dublin, ARGO, Journal of the European Academy of Dermatology and Venereology, Teaching hospital, HS, Hidradenitis suppurativa, Patient, CEST, MIRA, Venereology, American College, Moonlake, News, Conference, Safety, Inflammation, Pharmaceutical industry, Dermatology

In June 2023, MoonLake announced positive topline 12-week Phase 2 MIRA trial results , achieving a landmark milestone as the first placebo-controlled randomized trial in HS to report positive top-line results using HiSCR75 as the primary endpoint.

Key Points: 
  • In June 2023, MoonLake announced positive topline 12-week Phase 2 MIRA trial results , achieving a landmark milestone as the first placebo-controlled randomized trial in HS to report positive top-line results using HiSCR75 as the primary endpoint.
  • Professor Brian Kirby MD, FRCPI, Charles Department of Dermatology, St. Vincent’s University Hospital and Charles Institute of Dermatology, University College Dublin, Dublin, Ireland will be presenting the results in a late-breaking news presentation, details of which are included below.
  • Date and time: Wednesday, 11 October; session 14.15 - 17.30 CEST, presentation 16.15 - 16.30 CEST
    Presentation title: Efficacy and safety of the IL-17A- and IL-17F-inhibiting Nanobody® sonelokimab in patients with active, moderate-to-severe hidradenitis suppurativa: Results from the global, randomized, double-blind, placebo-controlled Phase 2 MIRA trial
    The 24-week Phase 2 MIRA trial data for Nanobody® sonelokimab in hidradenitis suppurativa is anticipated imminently.
  • In addition, top-line 12-week results for MoonLake’s Phase 2 ARGO trial with Nanobody® sonelokimab in psoriatic arthritis (PsA) are expected in the first half of November 2023, ahead of the American College of Rheumatology Conference, November 10-15.

Scinai Immunotherapeutics Innovative Plaque Psoriasis Treatment Shows Encouraging Preclinical Results

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수요일, 9월 13, 2023
China Biologic Products, IBN, Injection, Plaque, Asthma, NVS, Therapy, Dermis, AMD, University Medical Center, Hook effect, I&I, 3D, European Medicines Agency, COVID-19, Clinical trial, Infection, Inflammation, IL-17A, Psoriasis, EMA, VHH, LLY, UCB, Novartis, Patient, Lilly, Risk, Max Planck Institute for Multidisciplinary Sciences, Brussels Stock Exchange, UMG, Mab, CCL20, CXCL1, AF, Research, Moonlake, NYSE, Max Planck Society, Skin, Autoimmunity, Disease, Pharmaceutical industry, Vaccine

JERUSALEM, Sept. 13, 2023 (GLOBE NEWSWIRE) -- via IBN – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, today announces encouraging results in a preclinical study of Scinai’s anti‑interleukin 17 (IL‑17) NanoAbs as a treatment for plaque psoriasis.

Key Points: 
  • Results from ex-vivo study in human psoriatic skin anticipated in Q4 2023; In-vivo animal study results anticipated in early 2024
    JERUSALEM, Sept. 13, 2023 (GLOBE NEWSWIRE) -- via IBN – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, today announces encouraging results in a preclinical study of Scinai’s anti‑interleukin 17 (IL‑17) NanoAbs as a treatment for plaque psoriasis.
  • These results suggest NanoAbs’ therapeutic potential to relieve symptoms of plaque psoriasis.
  • Research shows that targeting IL-17F isoform in addition to IL-17A provides higher efficacy in treating plaque psoriasis.
  • Scinai recently started to evaluate the anti-IL-17 NanoAbs in a full human skin model induced for plaque psoriasis to evaluate the effective dose and schedule of treatment, with in-vivo animal studies anticipated in early 2024.