IL-17A

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

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Thursday, March 28, 2024
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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

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Wednesday, March 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

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Thursday, March 28, 2024
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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

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Monday, March 11, 2024
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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
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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.

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

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Wednesday, December 27, 2023
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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.

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

Retrieved on: 
Tuesday, November 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.

ACELYRIN, INC. Reports Third Quarter 2023 Financial Results and Recent Highlights

Retrieved on: 
Tuesday, November 7, 2023
SLRN, Research, American College, MDA, Quality of life, Inflammation, Doctor of Philosophy, Hidradenitis suppurativa, Graves' ophthalmopathy, GxP, Disease, DRS, LOS, LEI, I&I, Secukinumab, Shep, Abscess, Shepherd (name), Axial spondyloarthritis, Amgen, Webcast, TED, Safety, Patient, D, Week, FRCP, MD, MRCP, Development, Growth, Clinical trial, Internal, Suicidal ideation, INC, Enthesitis, Psoriatic arthritis, FDA, CMC, Poster, National Center for Advancing Translational Sciences, Senior, Psoriasis, IL-17A, Cryptocurrency, Pharmaceutical industry, Medical device, Management

LOS ANGELES, Nov. 07, 2023 (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 third quarter ended September 30, 2023 and highlighted additional corporate updates and milestones.

Key Points: 
  • (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 third quarter ended September 30, 2023 and highlighted additional corporate updates and milestones.
  • For the quarter ended September 30, 2023, these expenses include a stock-based compensation expense of $11.7 million.
  • Net Loss: Net loss totaled $83.9 million for the third quarter of 2023, or $0.87 per share, compared to $14.4 million or $8.17 per share for the third quarter of 2022.
  • ET to review its third quarter 2023 financial results.

Phase 3 Data Analysis Presented at EADV 2023 Showed Bimekizumab Achieved High Thresholds of Clinical Response in Hidradenitis Suppurativa

Retrieved on: 
Thursday, October 12, 2023
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There is a compelling need for new treatment options that can offer high and durable clinical response," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

Key Points: 
  • There is a compelling need for new treatment options that can offer high and durable clinical response," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
  • "Data presented at EADV showed that over 48 weeks many patients treated with bimekizumab achieved high thresholds of response.
  • These findings suggest that inhibition of IL-17F in addition to IL-17A represents a promising treatment approach in moderate-to-severe hidradenitis suppurativa."
  • "The bimekizumab Phase 3 clinical trial program in hidradenitis suppurativa included the more stringent clinical outcomes of HiSCR75, HiSCR90 and HiSCR100 in addition to the standard HiSCR50.