Hidradenitis suppurativa

Avalo Therapeutics Appoints Biotech Leaders to Board of Directors

Retrieved on: 
Tuesday, April 2, 2024
Independent, Business school, Bachelor of Science, Engineering, Bristol Myers Squibb, Thayer School of Engineering, Immunology, Therapy, Corporate development, Corporation, True north, ICON PLC, Business, Dartmouth College, Biogen, ATP, Genzyme, Cardiology, Biomedical engineering, Novo Nordisk, Drug discovery, Tuck School of Business, Acquisition, University, MBBS, AbbVie, Bioverativ, ICON, CBO, Columbia University, Biology, MBA, Hidradenitis suppurativa, TRML, Partner, Military, Management

The Avalo Board brings together a team with expertise spanning finance, business operations, drug discovery and clinical development.

Key Points: 
  • The Avalo Board brings together a team with expertise spanning finance, business operations, drug discovery and clinical development.
  • The recent board appointments include Aaron Kantoff, Jonathan Goldman, and Samantha Truex as Independent Directors.
  • He has spent over a decade specializing in founding, building and investing in biotech companies.
  • Samantha also chairs the Board of Advisors for Thayer School of Engineering at Dartmouth and is a member of the Board of Advisors for Life Science Cares.

CMS and Incyte Announce Collaboration and License Agreement for Povorcitinib in China and Southeast Asia

Retrieved on: 
Monday, April 1, 2024
Dermatology, Vitiligo, Prurigo nodularis, Patient, Collaboration, Research, Asthma, JAK1, HS, Hidradenitis suppurativa, PN, CMS, Autoimmunity, Pharmaceutical industry

Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.

Key Points: 
  • Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
  • CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
  • “We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Herve Hoppenot, Chief Executive Officer, Incyte.
  • Upon approval, povorcitinib is poised to synergize with the innovative drugs in the commercialization stage of our pipeline ILUMETRI (tildrakizumab injection), original drugs including Hirudoid (mucopolysaccharide polysulfate cream) and Aethoxysklerol (polidocanol injection) in terms of our network and market resources, which will help the Product to realize its clinical and commercial value.”
    The transaction is effective immediately upon the execution of the Collaboration and License Agreement.

Avalo Reports 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 29, 2024
Exercise, Patient, Research, Acquisition, Inflammation, Net, HS, Therapy, OrbiMed, Hidradenitis suppurativa, Phase II, BTLA, Pharmaceutical industry

Increased cash position with private placement financing in March 2024 providing up to $185 million, including initial upfront investment of $115.6 million

Key Points: 
  • Increased cash position with private placement financing in March 2024 providing up to $185 million, including initial upfront investment of $115.6 million
    WAYNE, Pa. and ROCKVILLE, Md., March 29, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced business updates and year-end financial results for 2023.
  • The progress we made in 2023 to strengthen our balance sheet helped enable these transactions.
  • “Our focus in 2024 is executing operationally on the development of AVTX-009 for the treatment of hidradenitis suppurativa.
  • As of December 31, 2023, Avalo had $7.4 million in cash and cash equivalents.

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.

Avalo Acquires Anti-IL-1β mAb and Announces Private Placement Financing of up to $185 Million

Retrieved on: 
Wednesday, March 27, 2024
Eli Lilly, Disease, Half-life, Partnership, Patient, Sale, Acquisition, Inflammation, Therapy, OrbiMed, Hidradenitis suppurativa, Probability, Autoimmune disease

Executed private placement financing of up to $185 million, including initial upfront investment of $115.6 million; expected to extend cash runway into 2027

Key Points: 
  • Executed private placement financing of up to $185 million, including initial upfront investment of $115.6 million; expected to extend cash runway into 2027
    Webcast to be held tomorrow, March 28, 2024 at 8:30 a.m. E.T.
  • The private placement will provide up to $185 million in gross proceeds, including an initial gross upfront investment of $115.6 million.
  • After deducting estimated transaction costs from both the private placement financing and the acquisition of AlmataBio, Avalo expects net upfront proceeds to be approximately $105 million.
  • The private placement is expected to close on March 28, 2024, subject to the satisfaction of customary closing conditions.

Incyte and CMS Announce Collaboration and License Agreement for Povorcitinib, an Oral JAK1 Inhibitor, in Mainland China, Hong Kong, Macau, Taiwan and Southeast Asia

Retrieved on: 
Monday, April 1, 2024
Research, Biotechnology, Other Health, Health, Cosmetics, Pharmaceutical, Retail, Science, Oncology, Dermatology, Vitiligo, Prurigo nodularis, Patient, Collaboration, Asthma, JAK1, HS, Hidradenitis suppurativa, PN, CMS, Autoimmunity, Pharmaceutical industry

Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.

Key Points: 
  • Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.
  • Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
  • CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
  • “We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Hervé Hoppenot, Chief Executive Officer, Incyte.

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 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.

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.

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.