Atopic dermatitis

Arcutis Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 27, 2024

The Company saw significant GTN improvement in the fourth quarter compared to the GTN in the third quarter, and anticipates further GTN improvement in 2024.

Key Points: 
  • The Company saw significant GTN improvement in the fourth quarter compared to the GTN in the third quarter, and anticipates further GTN improvement in 2024.
  • Total revenues for the quarter ended December 31, 2023 were $13.5 million compared to $3.0 million for the corresponding period in 2022.
  • Net cash used in operating activities was $56.2 during the fourth quarter and $247.1 million during the full year 2023.
  • Arcutis management will host a conference call and webcast today at 8:30 am ET to discuss the financial results for the quarter and year and provide a business update.

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Tuesday, February 27, 2024

Aclaris reported positive results from its Phase 1 MAD trial of ATI-2138 in September 2023.

Key Points: 
  • Aclaris reported positive results from its Phase 1 MAD trial of ATI-2138 in September 2023.
  • Net loss was $1.5 million for the fourth quarter of 2023 compared to $27.6 million for the fourth quarter of 2022.
  • Total revenue was $17.6 million for the fourth quarter of 2023 compared to $7.8 million for the fourth quarter of 2022.
  • Licensing expenses were $5.7 million for the quarter ended December 31, 2023 compared to $0.6 million for the prior year period.

Derm-Biome Pharmaceuticals prepares to begin IND-enabling studies for DB-007-4, a potential best-in-class treatment for inflammatory skin diseases

Retrieved on: 
Tuesday, February 27, 2024

Toxicology studies are an essential part of drug development as they help to evaluate the potential safety and toxicity of a drug candidate before it is tested on humans.

Key Points: 
  • Toxicology studies are an essential part of drug development as they help to evaluate the potential safety and toxicity of a drug candidate before it is tested on humans.
  • There is a real need for skin disease drugs that offer high efficacy and a low risk of adverse effects with long-term use.
  • For conditions like AD, an inflammatory skin disease that affects up to 25% of babies and young children, there is a need for safer treatment options.
  • DB-007-4 is a topical multi-disease treatment that targets important pathways that play a vital role in the development of inflammatory skin diseases while being well-tolerated by skin.

Kymera Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, February 22, 2024

Under the terms of the Sanofi/Kymera collaboration, the dosing of the first patients generated milestone payments totaling $55 million.

Key Points: 
  • Under the terms of the Sanofi/Kymera collaboration, the dosing of the first patients generated milestone payments totaling $55 million.
  • Enrollment in both trials is ongoing, with topline data expected to be reported in the first half of 2025.
  • Kymera unveiled its first-in-class oral STAT6 degrader, KT-621, at its Immunology R&D Day in January.
  • To access the conference call via phone, please dial +1 (833) 630-2127 or +1 (412) 317-1846 (International) and ask to join the Kymera Therapeutics call.

RAPT Investigation Alert: Kessler Topaz Meltzer & Check, LLP is Investigating Securities Fraud Claims on Behalf of Investors of RAPT Therapeutics, Inc. (NASDAQ: RAPT)

Retrieved on: 
Wednesday, February 21, 2024

RADNOR, Pa., Feb. 21, 2024 (GLOBE NEWSWIRE) -- The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) is currently investigating potential violations of the federal securities laws on behalf of investors of RAPT Therapeutics, Inc. (NASDAQ: RAPT) (“RAPT”).

Key Points: 
  • RADNOR, Pa., Feb. 21, 2024 (GLOBE NEWSWIRE) -- The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) is currently investigating potential violations of the federal securities laws on behalf of investors of RAPT Therapeutics, Inc. (NASDAQ: RAPT) (“RAPT”).
  • If you are a RAPT investor and would like to learn more about our investigation, please CLICK HERE to fill out our online form or contact Kessler Topaz Meltzer & Check, LLP : Jonathan Naji, Esq.
  • Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world.
  • For more information about Kessler Topaz Meltzer & Check, LLP , please visit www.ktmc.com .

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of RAPT Therapeutics, Inc. - RAPT

Retrieved on: 
Wednesday, February 21, 2024

NEW YORK, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of RAPT Therapeutics, Inc. (“RAPT” or the “Company”) (NASDAQ: RAPT).

Key Points: 
  • NEW YORK, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of RAPT Therapeutics, Inc. (“RAPT” or the “Company”) (NASDAQ: RAPT).
  • The investigation concerns whether RAPT and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Investigation of RAPT Therapeutics, Inc. (RAPT) Announced by Holzer & Holzer, LLC

Retrieved on: 
Tuesday, February 20, 2024

ATLANTA, Feb. 20, 2024 (GLOBE NEWSWIRE) --  Holzer & Holzer, LLC is investigating whether RAPT Therapeutics, Inc. (“RAPT Therapeutics,” or the “Company”) (NASDAQ: RAPT) complied with federal securities laws.

Key Points: 
  • ATLANTA, Feb. 20, 2024 (GLOBE NEWSWIRE) --  Holzer & Holzer, LLC is investigating whether RAPT Therapeutics, Inc. (“RAPT Therapeutics,” or the “Company”) (NASDAQ: RAPT) complied with federal securities laws.
  • If you purchased RAPT Therapeutics stock and suffered a loss on that investment, you are encouraged to contact Corey Holzer, Esq.
  • Holzer & Holzer, LLC, an ISS top rated securities litigation law firm for 2021, dedicates its practice to vigorous representation of shareholders and investors in litigation nationwide, including shareholder class action and derivative litigation.
  • Holzer & Holzer, LLC has paid for the dissemination of this promotional communication, and Corey Holzer is the attorney responsible for its content.

RAPT Therapeutics Announces Clinical Hold on Studies Evaluating Zelnecirnon

Retrieved on: 
Tuesday, February 20, 2024

SOUTH SAN FRANCISCO, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced that the U.S. Food and Drug Administration (FDA) has verbally notified the company that a clinical hold has been placed on the company’s Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis and its Phase 2a trial in asthma. The company expects to receive a formal clinical hold letter from the FDA. The clinical hold determination was based on a serious adverse event of liver failure in one patient in the atopic dermatitis trial, the cause of which is currently unknown but which has been characterized as potentially related to zelnecirnon. Dosing of zelnecirnon has been halted in both clinical trials, as has enrollment of new trial participants. The clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.

Key Points: 
  • The company expects to receive a formal clinical hold letter from the FDA.
  • Dosing of zelnecirnon has been halted in both clinical trials, as has enrollment of new trial participants.
  • The clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.
  • The live webcast and audio archive of the presentation may be accessed on the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations .

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
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      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

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      Table of contents

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      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

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      in moderate to low-sized study populations
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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

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      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

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      considerations for allergen products within the scope of the guideline.

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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      quality and clinical development according to the current knowledge.

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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      conditions will require separate clinical trials (see Section 6).

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      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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      substantially to the allergen products as discussed above.

    • 1

      156

      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      of allergic diseases - CHMP/EWP/18504/2006
      ?

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      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      product specific.

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      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

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      7.1.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

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      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      8.2.1.

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      In general, sensitivity and specificity of the product should be determined.

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      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
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      EMA/CHMP/72790/2024

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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LEO Pharma Presents New Long-Term Adbry® (tralokinumab-ldrm) Data in Adults with Moderate-to-Severe Atopic Dermatitis at the 2024 AAD Annual Meeting

Retrieved on: 
Friday, March 8, 2024

LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).
  • The findings are being shared via an e-poster at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1
    The results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology.
  • “The data presented for Adbry at AAD further builds upon an established, wide-ranging collection of clinical evidence that aims to improve the support for those living with moderate-to-severe AD,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.
  • “This new analysis demonstrates the benefits of the long-term use of Adbry for adults who live with this chronic condition.”