Prurigo

Sanofi/Regeneron's Dupixent Performance in Eosinophilic Esophagitis is Paving the Way for Future Therapies in an Underserved and Growing Market, According to Spherix Global Insights

Retrieved on: 
Tuesday, April 4, 2023

EXTON, Pa., April 3, 2023 /PRNewswire/ -- In 2017, Sanofi/Regeneron announced the FDA approval for the first biologic agent to treat atopic dermatitis (AD). The success of that drug, Dupixent (dupilumab), inspired competitors to scramble for a place in the AD market, with the second drug arriving nearly five years later. Sanofi/Regeneron followed with indications in asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis (EoE) and most recently prurigo nodularis.

Key Points: 
  • Sanofi/Regeneron followed with indications in asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis (EoE) and most recently prurigo nodularis.
  • The May 2022 approval of Dupixent for EoE opened the door to another untapped market, with the closest competitor entry likely several years away.
  • Spherix will continue to track the performance of Dupixent's launch for the first eighteen months on the market.
  • Performance to date suggests Dupixent will continue to carve out a commanding ownership of the advanced treatment market in EoE, while also paving the way for future competitors to meet the needs of this underserved, growing market.

AAD 2023: Late-Breaking Phase III Results Demonstrate nemolizumab’s Significant Impact on Prurigo Nodularis

Retrieved on: 
Saturday, March 18, 2023

Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.

Key Points: 
  • Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.
  • The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis.
  • “We are so pleased that we’re able to bring so much powerful new data to this year’s AAD congress.
  • Its continued commitment to delivering science and innovation across a highly differentiated portfolio is reflected in its extensive presence at AAD.

Celldex Reports Fourth Quarter and Year End 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 28, 2023

HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.
  • Celldex believes her deep background in drug development strongly complements the current Board’s skills and experiences.
  • Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity.
  • The litigation settlement related loss had a ($0.32) impact on net loss per share for the twelve months ended December 31, 2022.

Press Release: Dupixent® (dupilumab) late-breaking Phase 3 data at EADV 2022 showed significant improvements in signs and symptoms of prurigo nodularis

Retrieved on: 
Thursday, September 8, 2022

These data from one of two pivotal trials in prurigo nodularis show Dupixent significantly reduced itch and skin lesions at 24 weeks.

Key Points: 
  • These data from one of two pivotal trials in prurigo nodularis show Dupixent significantly reduced itch and skin lesions at 24 weeks.
  • The late-breaking data presented at the EADV 2022 Congress are from the randomized, placebo-controlled Phase 3 PRIME trial, which met its primary and key secondary endpoints.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indication.
  • AEs most commonly observed with Dupixent (5%) included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo).

GALDERMA Showcases Its Continued Commitment to Innovation in Dermatology With New Data to Be Presented at 2022 EADV Congress

Retrieved on: 
Tuesday, September 6, 2022

Galderma has announced it will be showcasing its latest scientific updates at the 31st European Academy of Dermatology and Venereology (EADV) congress in Milan, September 7-10, 2022.

Key Points: 
  • Galderma has announced it will be showcasing its latest scientific updates at the 31st European Academy of Dermatology and Venereology (EADV) congress in Milan, September 7-10, 2022.
  • As the pure-play dermatology leader, Galdermas significant presence at EADV reaffirms its commitment to delivering a truly innovative, science-based portfolio of premium cutting-edge brands and services.
  • Two symposia and eight scientific posters will examine the disease burden, the role of IL-31 in these inflammatory skin conditions and treatments under development.
  • EADV congress to exchange information, share insights and
    GLOBAL HEAD OF RESEARCH & DEVELOPMENT, GALDERMA
    Below is a full list of activities taking place.

FDA approves the first treatment option for generalized pustular psoriasis flares in adults

Retrieved on: 
Thursday, September 1, 2022

We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares."

Key Points: 
  • We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares."
  • Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares (episodes of widespread eruptions of painful, sterile pustules).
  • SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) flares in adults.
  • Your healthcare provider should watch you closely for signs and symptoms of TB after treatment with SPEVIGO.

Trevi Therapeutics to Host Virtual R&D Day on September 19, 2022

Retrieved on: 
Tuesday, August 30, 2022

NEW HAVEN, Conn., Aug. 30, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis (IPF), today announced that it will host a virtual R&D Day on Monday, September 19, 2022, from 10:00 AM to 12:30 PM Eastern Time.

Key Points: 
  • They will be joined by Trevi's leadership team who will provide an update on the Company's development plans for Haduvio, followed by a live Q&A session.
  • A live webcast, including audio, video, and presentation slides, will be accessible on ir.trevitherapeutics.com at the time of the meeting.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.
  • Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Kiniksa Pharmaceuticals Announces Global License Agreement with Genentech for Vixarelimab

Retrieved on: 
Wednesday, August 3, 2022

HAMILTON, Bermuda, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced a global license agreement with Roche and Genentech, a member of the Roche Group (Genentech), for the rights to develop and commercialize vixarelimab, a fully human monoclonal antibody targeting oncostatin M receptor beta (OSMRβ).

Key Points: 
  • The agreement provides an optimal infrastructure for the further development of vixarelimab.
  • Under the terms of the global license agreement, Kiniksa will receive $100 million in upfront and near-term payments, and is eligible to receive up to approximately $600 million in certain clinical, regulatory, and sales-based milestones, before fulfilling upstream financial obligations.
  • Kiniksa has completed screening patients for the Phase 2b clinical trial of vixarelimab in prurigo nodularis.
  • ARCALYST is a registered trademark of Regeneron Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

Galderma Announces Positive Data From Phase III Trial, Demonstrating Efficacy and Safety of nemolizumab in Patients with Prurigo Nodularis

Retrieved on: 
Wednesday, June 22, 2022

These phase III trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis.

Key Points: 
  • These phase III trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis.
  • OLYMPIA 2, part of the largest clinical program in prurigo nodularis to date aiming to recruit 540 patients, is a pivotal phase III clinical trial, evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis after a 16-week treatment period.
  • The results of OLYMPIA 2 provide further evidence that nemolizumab effectively improves skin lesions and pruritus in patients with prurigo nodularis.
  • A second phase III trial investigating the efficacy of nemolizumab in patients with prurigo nodularis, named OLYMPIA 1, is ongoing.

Press release: Late-breaking Phase 3 data at AAD 2022 show Dupixent® (dupilumab) significantly improved signs and symptoms of prurigo nodularis

Retrieved on: 
Saturday, March 26, 2022

The companies previously announced topline results from PRIME2 and a second trial called PRIME investigating the use of Dupixent in adults with uncontrolled prurigo nodularis.

Key Points: 
  • The companies previously announced topline results from PRIME2 and a second trial called PRIME investigating the use of Dupixent in adults with uncontrolled prurigo nodularis.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indications.
  • For the 24-week treatment period, overall rates of adverse events were generally similar between Dupixent and placebo groups (57% Dupixent, 51% placebo).
  • Data from both trials will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis, which are planned to begin in the first half of 2022.