Psoriatic arthritis

ARCA biopharma and Oruka Therapeutics Announce Merger Agreement

Retrieved on: 
Wednesday, April 3, 2024
Paragon, Freedom, Psoriasis, Biotechnology, ARCA, Disease, Patient, Paradigm, Psoriatic arthritis, Standard of care, Doctor of Philosophy, Investment, RTW, Engineering, Pharmaceutical industry

WESTMINSTER, Colo. and WALTHAM, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ: ABIO) (“ARCA”), and Oruka Therapeutics (“Oruka”), a privately held biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, including plaque psoriasis, announced today that they have entered into a definitive agreement to combine the companies in an all-stock transaction. The resulting entity will focus on advancing Oruka’s pipeline of potentially best-in-class biologics, including ORKA-001 (an IL-23p19 inhibitor) and ORKA-002 (an IL-17A/F inhibitor). Upon completion of the merger, the combined company plans to operate under the name Oruka Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “ORKA”.

Key Points: 
  • Upon completion of the merger, the combined company plans to operate under the name Oruka Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “ORKA”.
  • In addition, prior to closing of the merger, ARCA expects to declare a cash dividend to the pre-merger ARCA stockholders equal to the amount by which ARCA’s net cash exceeds $5 million.
  • “Our mission at Oruka is to offer people affected with chronic skin diseases the most possible freedom from their condition.
  • Oruka is the third company founded based on assets generated by Paragon Therapeutics (“Paragon”).

ARCA biopharma and Oruka Therapeutics Announce Merger Agreement

Retrieved on: 
Wednesday, April 3, 2024
Paragon, Freedom, Psoriasis, Biotechnology, ARCA, Disease, Patient, Paradigm, Psoriatic arthritis, Standard of care, Doctor of Philosophy, Investment, RTW, Engineering, Pharmaceutical industry

WESTMINSTER, Colo. and WALTHAM, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ: ABIO) (“ARCA”), and Oruka Therapeutics (“Oruka”), a privately held biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, including plaque psoriasis, announced today that they have entered into a definitive agreement to combine the companies in an all-stock transaction. The resulting entity will focus on advancing Oruka’s pipeline of potentially best-in-class biologics, including ORKA-001 (an IL-23p19 inhibitor) and ORKA-002 (an IL-17A/F inhibitor). Upon completion of the merger, the combined company plans to operate under the name Oruka Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “ORKA”.

Key Points: 
  • Upon completion of the merger, the combined company plans to operate under the name Oruka Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “ORKA”.
  • In addition, prior to closing of the merger, ARCA expects to declare a cash dividend to the pre-merger ARCA stockholders equal to the amount by which ARCA’s net cash exceeds $5 million.
  • “Our mission at Oruka is to offer people affected with chronic skin diseases the most possible freedom from their condition.
  • Oruka is the third company founded based on assets generated by Paragon Therapeutics (“Paragon”).

ACELYRIN, INC. Reports Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Thursday, March 28, 2024
Research, IL-17A, Strategic planning, Cell, Exophthalmos, Disease, Infection, Fungus, Risk, Inflammation, SLRN, Patient, Psoriatic arthritis, Acquisition, Doctor of Philosophy, MD, Quality of life, CAS, Senior, IPR, Eye, NeoGenomics, Graves' ophthalmopathy, Suicidal ideation, Behavior, Hidradenitis suppurativa, QW, Drug development, LOS, Corporate communication, Abscess, Diplopia, Pharmaceutical industry

LOS ANGELES, March 28, 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 reported financial results for the full year ended December 31, 2023 and highlighted recent corporate updates and upcoming milestones.

Key Points: 
  • R&D Expenses: Research and development expenses were $355.9 million for the full year ended December 31, 2023, as compared to $55.6 million for 2022.
  • G&A Expenses: General and administrative expenses were $66.2 million for the full year ended December 31, 2023, as compared to $13.5 million for 2022.
  • Net Loss: Net loss for the full year ended December 31, 2023 was $381.6 million, compared to $64.8 million for 2022.
  • In December 2023, the Company announced the appointment of Lynn Tetrault to its Board of Directors.

AMERICAN SKIN ASSOCIATION ANNOUNCES NEW BOARD MEMBER JOSEPH F. MEROLA, MD, MMSc, FAAD, FACR

Retrieved on: 
Thursday, April 4, 2024
Cone Health Women's Hospital, Internal medicine, Patient, Skin, FAAD, Connective tissue, DSM-IV codes, Education, ASA, MDS, MMSc, Mass, Harvard Medical School, Associate, National Psoriasis Foundation, Psoriatic arthritis, Hospital, Public health, Atopic dermatitis, Dermatomyositis, Lupus, American Academy, Assessment, Management

NEW YORK, April 4, 2024 /PRNewswire/ -- American Skin Association (ASA) announced today that Joseph F. Merola, MD, MMSc, FAAD, FACR, will join its Board of Directors.

Key Points: 
  • NEW YORK, April 4, 2024 /PRNewswire/ -- American Skin Association (ASA) announced today that Joseph F. Merola, MD, MMSc, FAAD, FACR, will join its Board of Directors.
  • Distinguished Chair in Dermatology and is Professor at the Peter O'Donnell Jr. School of Public Health.
  • "We are proud to announce the addition of Dr. Joseph Merola to ASA's Board of Directors.
  • He was recently elected to the Board of the American Academy of Dermatology.

FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations

Retrieved on: 
Thursday, April 4, 2024
Week, Psoriasis, Ankylosing spondylitis, Patient, UCB, HS, Psoriatic arthritis, Injection, Safety, FDA, Food, Pharmaceutical industry

In addition, a second sBLA for the BIMZELX 2mL device presentations has also been accepted.

Key Points: 
  • In addition, a second sBLA for the BIMZELX 2mL device presentations has also been accepted.
  • "We are excited to share progress on our FDA applications.
  • "In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients.
  • Approval of the 2mL device presentations would mean that patients would have an alternative one-injection regimen option."

Withdrawn application: Orencia, 19/02/2024

Retrieved on: 
Wednesday, April 3, 2024
CD86, Graft-versus-host disease, Gene, Methotrexate, Psoriasis, Letter, Cell, Bone marrow, Risk, Inflammation, Patient, Ageing, Psoriatic arthritis, HSCT, Allele, Joint, Protein, HLA, European Medicines Agency, Arthritis, Syringe, Rheumatism, Agency, Clinical trial, Skin, CD80, Cancer, Immune system, Blood, Calcineurin, Medicine, Vaccine

Withdrawn application: Orencia, 19/02/2024

Key Points: 


Withdrawn application: Orencia, 19/02/2024

Summary of opinion: Bimzelx, 21/03/2024 Positive

Retrieved on: 
Wednesday, April 3, 2024
Civil service commission, Psoriatic arthritis, Hidradenitis suppurativa, Methotrexate, Psoriasis, MRI, Magnetic resonance imaging, Inflammation, Committee, Nonsteroidal anti-inflammatory drug, Disease-modifying antirheumatic drug, HS, Medication package insert, C-reactive protein, Ankylosing spondylitis, European Commission, Marketing, CHMP, CRP, Axial spondyloarthritis

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.
  • The marketing authorisation holder for this medicinal product is UCB Pharma S.A.
  • The CHMP adopted a new indication for the treatment of hidradenitis suppurativa.
  • Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
    Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

ACELYRIN, INC. Announces Positive Top-line Results from Its Global Phase 2b/3 Clinical Trial of Izokibep in Psoriatic Arthritis

Retrieved on: 
Monday, March 11, 2024
MACR, Psoriatic arthritis, 1991 World Sportscar Championship, INC, Doctor of Philosophy, LOS, MD, SLRN, ISR, Rheumatology, Skin, Safety, Joint, Swedish Health Services, Enthesitis, Patient, Medicine, HS, LEI, Phase, 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 its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance. Results from the 160 mg weekly (QW) and every other week (Q2W) arms showed improved magnitude of responses on higher hurdle endpoints such as ACR70, PASI100, and Minimal Disease Activity relative to the Phase 2 80 mg Q2W dose. This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.

Key Points: 
  • (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance.
  • This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.
  • Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class, without evidence of the safety liabilities observed with targeting IL-17A&F.
  • This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.”

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

Retrieved on: 
Monday, March 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.

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.