IL-17A

MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

Retrieved on: 
Donnerstag, Mai 16, 2024
IL-17A, Patient, University of Miami, Food, European Medicines Agency, Clinical trial, University, Depression, FDA, Associate professor, Moonlake, Single-domain antibody, Inflammation, MIRA, EMA, Tissue, Scar, HS, Pain, VELA, MAS, Pharmaceutical industry

Sonelokimab is designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues.

Key Points: 
  • Sonelokimab is designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues.
  • Following the positive results from the landmark Phase 2 MIRA trial, the Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2.
  • The Phase 3 program will use a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS.
  • The topline primary endpoint readout (week 16) from the VELA program is expected as of mid-2025.

ACELYRIN, INC. Provides Business Update and Highlights Key Upcoming Milestones

Retrieved on: 
Donnerstag, Mai 9, 2024
Psoriatic arthritis, Hyperglycemia, Graves' ophthalmopathy, Abscess, Huber loss, Risk, QW, Hidradenitis suppurativa, Conference, Webcast, Suicidal ideation, Development, MRCP, Disease, Patient, Fungus, LOS, SLRN, Diplopia, FRCP, IL-17A, POC, CAS, Quality of life, Exophthalmos, Behavior, Infection, Pharmaceutical industry

LOS ANGELES, May 09, 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 provided an update on various corporate milestones.

Key Points: 
  • This Phase 2b/3 trial, designed to be the first of two registrational trials in TED, is planned to be initiated in the second half of 2024.
  • Izokibep in Uveitis (UV): ACELYRIN expects to complete enrollment in the ongoing Phase 2b/3 trial this month and top line data are anticipated by year-end 2024.
  • ACELYRIN expects to report cash, cash equivalents, and short-term marketable securities of $678.5 million at March 31, 2024.
  • Gil Labrucherie, who serves as ACELYRIN’s Chief Financial Officer, has also been named Chief Business Officer in addition to Chief Financial Officer.

Novartis’ Intravenous Formulation of Cosentyx Impacting Prescriber Preferences in Psoriatic Arthritis Treatment, While Pending Launch of UCB’s Bimzelx Poised to Further Disrupt the Market

Retrieved on: 
Dienstag, April 16, 2024
Psoriatic arthritis, Launch, HCP, Rheumatology, Patient, Need for Speed, Benchmarking, MOA, RealTime, IL-17A, Growth, Overalls, Ankylosing spondylitis, Pharmaceutical industry

Approximately five months post-approval, over one-third of US rheumatologists (n=104) report prescribing the IV formulation for their patients with PsA.

Key Points: 
  • Approximately five months post-approval, over one-third of US rheumatologists (n=104) report prescribing the IV formulation for their patients with PsA.
  • Furthermore, the vast majority feel the new formulation of Novartis’ IL-17-inhibitor brings some degree of advance over existing PsA treatments.
  • Receptivity to the IV formulation has also resulted in a greater affinity for the Cosentyx brand overall, specifically in comparison to long-standing IL-17 rival, Eli Lilly’s Taltz.
  • Launch tracking of Bimzelx will commence following approval and will continue for the first eighteen months of availability through the Launch Dynamix™ service.

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

Retrieved on: 
Donnerstag, März 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.

Matinas BioPharma Reports 2023 Financial Results and Provides a Business Update

Retrieved on: 
Mittwoch, März 27, 2024
Malignancy, Colitis, Survival, BioNTech, Patient, Lung, City, Standard of care, Quality of life, Fungal infection, Aspergillosis, Nationwide, Clinical trial, Bone marrow, Melanoma, Aspergillus fumigatus, Therapy, Human, Psoriasis, Partnership, World Health Organization, Coccidioides, Safety, Clutch (eggs), University, Kidney, Amphotericin B, Neoplasm, Research, Data monitoring committee, Infection, Skin, Vanderbilt University Medical Center, Hospital, Immunodeficiency, FDA, Critical, Element, Toxicity, IL-17A, Brain, Conference call, Conference, Johns Hopkins, Nephrotoxicity, Docetaxel, Serum, Inflammation, Mouse, Mortality, Fusarium, Bangladesh Technical Education Board, Pharmaceutical industry

BEDMINSTER, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports 2023 financial results and provides a business update.

Key Points: 
  • Aspergillus fumigatus is also included in the FDA qualified designation list of pathogens that pose a serious and life-threatening risk.
  • Revenue for 2023 was $1.1 million, which was generated from the Company’s research collaborations with BioNTech SE and Genentech Inc.
  • Cash, cash equivalents and marketable securities as of December 31, 2023 were $13.8 million compared with $28.8 million as of December 31, 2022.
  • Matinas will host a conference call and webcast today beginning at 4:30 p.m. Eastern time.

Zura Bio Reports Full Year 2023 Financial Results, Business Highlights, and Appoints Robert Lisicki as Chief Executive Officer

Retrieved on: 
Donnerstag, März 28, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, IL-17A, Administration, Ulcerative colitis, Congress, Thymic stromal lymphopoietin, Atopic dermatitis, Alopecia areata, Inflammation, Chronic obstructive pulmonary disease, Allergy, TSLP, BCA, CMC, G&A, Interleukin 7, Benaroya Research Institute, Business analyst, Abstract, Asthma, IL-7, Research and development, Drug development, Senior management, BAFF, Eli Lilly and Company, Translational medicine, Autoimmunity, Management

Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”) a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported full year 2023 financial results and recent business highlights.

Key Points: 
  • Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”) a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported full year 2023 financial results and recent business highlights.
  • The Company has also announced the appointment of Robert Lisicki as Chief Executive Officer (CEO), effective April 8, 2024, succeeding its Founding CEO, Someit Sidhu, M.D.
  • Mr. Lisicki joined Zura Bio in January 2024 as President and Chief Operating Officer.
  • Dr. Sidhu continued, "On behalf of the Management Team and Board, I am pleased to welcome Robert as the Chief Executive Officer.

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

Retrieved on: 
Montag, März 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: 
Montag, März 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: 
Sonntag, März 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.

Matinas BioPharma Demonstrates in vivo Biological Activity and Disease Improvement in Two Inflammatory Disease Models with Oral LNC-Delivered Small Oligonucleotides

Retrieved on: 
Mittwoch, Dezember 27, 2023
Liver, RNA interference, LNC, Small RNA, PCR, DSS, Inflammation, Serum, Animal, IL-17A, Commensurability, Colitis, Imiquimod, Lecture, Psoriasis, Oligonucleotide, Therapy, Vaccine

BEDMINSTER, N.J, Dec. 27, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform technology, announces results from a series of in vivo studies demonstrating successful oral delivery of two LNC-formulated small single-strand oligonucleotides that specifically target key inflammatory cytokines TNFα and IL-17A in well-established and validated animal models that mimic acute inflammatory responses seen in human diseases.

Key Points: 
  • Commensurate improvements in clinical disease markers and scores were also documented in both models,” said James Ferguson, M.D., Matinas’ Chief Medical Officer .
  • “While additional study is warranted, the successful oral delivery of small oligonucleotides is very exciting and we believe these data demonstrate how Matinas’ LNC platform could be used for the oral delivery of functional small oligonucleotides with potential therapeutic applications,” Dr. Ferguson added.
  • Both were advanced to in vivo studies to evaluate meaningful biological activity in relevant disease models.
  • In this model, while IL-17A serum levels were not expected to change, improvement was demonstrated in clinical disease markers of skin redness and scaling, further validating the biological activity of these small oligonucleotides.