Asthma

Apogee Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024

SAN FRANCISCO and WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology (I&I) indications, today reported pipeline highlights and fourth quarter and full year 2023 financial results.

Key Points: 
  • “2023 was a momentous year for Apogee with the completion of a successful IPO, initiation of our first clinical program of APG777 in healthy volunteers and the nomination of our second pipeline candidate, APG808,” said Michael Henderson, M.D., Chief Executive Officer of Apogee.
  • Cash Position: Cash, cash equivalents and marketable securities were $395.5 million as of December 31, 2023, compared to $151.9 million as of December 31, 2022.
  • Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into 4Q 2026.
  • Net loss increased primarily as a result of higher R&D and G&A operating expenses as described above, partially offset by higher interest income.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024

Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

Apogee to Host Conference Call and Webcast to Report Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases on March 5, 2024

Retrieved on: 
Monday, March 4, 2024

(Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology (I&I) indications, today announced it will report interim results from the Phase 1 APG777 healthy volunteer trial on Tuesday, March 5, 2024.

Key Points: 
  • (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology (I&I) indications, today announced it will report interim results from the Phase 1 APG777 healthy volunteer trial on Tuesday, March 5, 2024.
  • Following the announcement, the Company will host a conference call and webcast at 7:00am ET to discuss the results.
  • To access the live and archived webcast, please visit the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .
  • The archived webcast will be available for a limited time on the Company’s website.

ARS Pharmaceuticals announces neffy® meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study

Retrieved on: 
Monday, February 26, 2024

Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.

Key Points: 
  • Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.
  • “Urticaria is not only a standalone type I allergy disease, but also represents the most frequent symptom observed during type I allergic reactions including anaphylaxis.
  • neffy may provide episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients.
  • This would follow the anticipated FDA approval of neffy for allergic reactions (Type I) including anaphylaxis in the second half of 2024.

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 24, 2024

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Jasper Therapeutics Presents Data from Preclinical Briquilimab Studies at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting

Retrieved on: 
Friday, February 23, 2024

The two poster presentations cover separate studies that evaluated briquilimab in Mrgprb2-mediated drug-induced anaphylaxis (DIA) and passive systemic anaphylaxis (PSA).

Key Points: 
  • The two poster presentations cover separate studies that evaluated briquilimab in Mrgprb2-mediated drug-induced anaphylaxis (DIA) and passive systemic anaphylaxis (PSA).
  • Results from both studies demonstrated that a single dose of briquilimab protected against anaphylaxis, as measured by significantly higher core body temperatures in animals treated with briquilimab vs. untreated animals.
  • The oral presentation covers a study that evaluated briquilimab in allergic asthma, which demonstrated that a single dose of briquilimab significantly reduced the numbers of lung mast cells and bronchoalveolar lavage-recovered eosinophils.
  • Additionally, airway-infiltrated eosinophils and neutrophils, as well as airway hyper-responsiveness, decreased in briquilimab-treated mice, suggesting briquilimab has the potential to prevent allergic asthma via mast cell depletion.

Positive Results from CHAPTER-1 Phase 2 Study of Deucrictibant for the Prophylactic Treatment of HAE Attacks to be Presented at AAAAI 2024 Annual Meeting

Retrieved on: 
Thursday, February 22, 2024

CHAPTER-1 is a two-part, Phase 2 study evaluating the efficacy, safety, and tolerability of deucrictibant for long-term prophylaxis against angioedema attacks in HAE type 1 and type 2 (HAE-1/2).

Key Points: 
  • CHAPTER-1 is a two-part, Phase 2 study evaluating the efficacy, safety, and tolerability of deucrictibant for long-term prophylaxis against angioedema attacks in HAE type 1 and type 2 (HAE-1/2).
  • 34 participants were treated with double-blinded study drug (placebo or deucrictibant, 20 or 40 mg/day) for 12 weeks of treatment.
  • “These data validate the mechanism of deucrictibant to provide early and sustained protection from HAE attacks.
  • By better understanding and addressing these factors, we aspire to make our commitment to ‘pioneering science for patient choice’ a reality.”

Intrommune Therapeutics Presents Supporting Data Introducing a New Form of Food Allergy Treatment

Retrieved on: 
Thursday, February 22, 2024

NEW YORK, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Intrommune Therapeutics , Inc., a biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, announces data in a late-breaking poster presentation at this year’s American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting in Washington, D.C. supporting Oral Mucosal Immunotherapy (OMIT) as a potential new form of food allergy treatment.

Key Points: 
  • NEW YORK, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Intrommune Therapeutics , Inc., a biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, announces data in a late-breaking poster presentation at this year’s American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting in Washington, D.C. supporting Oral Mucosal Immunotherapy (OMIT) as a potential new form of food allergy treatment.
  • This data demonstrates that OMIT, an investigational treatment, which delivers allergenic proteins utilizing an innovative, specially formulated toothpaste, can safely be used to treat patients with food allergies in a more convenient way than food allergy therapies currently available.
  • The results of this study suggest OMIT as a new approach for the management of food allergy, providing a strong foundation for further research in the pediatric population.
  • The addition of OMIT as a new, safe and convenient option for both patients and physicians, marks an important advancement in the treatment of food allergies.

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 .