zelnecirnon (RPT193) / RAPT Therap - LARVOL DELTA

RAPT Therapeutics Reports Third Quarter 2024 Financial Results (GlobeNewswire) - "Third Quarter Ended September 30, 2024...Research and development expenses for the third quarter of 2024 were $13.3 million, compared to $27.0 million for the same period in 2023. The decrease in research and development expenses was primarily due to lower development costs related to zelnecirnon, tivumecirnon and early stage programs, as well as decreased expenses for personnel, consultants and lab supplies....Research and development expenses for the nine months ended September 30, 2024 were $60.8 million, compared to $74.2 million for the same period in 2023. The decrease in research and development expenses was primarily due to decreases in development costs related to zelnecirnon, tivumecirnon and early-stage programs, as well as lab supplies, partially offset by increased expenses for personnel, consultants, facilities and non-cash stock-based compensation."

Commercial • Inflammation • Oncology • Solid Tumor

RAPT Therapeutics Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "RAPT Therapeutics...reported financial results...Second Quarter Ended June 30, 2024...Research and development expenses for the second quarter of 2024 were $22.6 million...The increase in research and development expenses was primarily due to higher development costs related to zelnecirnon, as well as increased expenses for personnel, consultants, facilities and non-cash stock-based compensation, partially offset by decreases in development costs related to tivumecirnon and early-stage programs as well as lab supplies costs...Research and development expenses for the six months ended June 30, 2024 were $47.4 million....The increase in research and development expenses was primarily due to increased expenses for personnel, consultants, facilities and non-cash stock-based compensation, partially offset by decreases in development costs related to zelnecirnon, tivumecirnon, early-stage programs and lab supplies costs."

Commercial • Asthma • Atopic Dermatitis • Hematological Malignancies • Immunology • Oncology • Respiratory Diseases • Solid Tumor

RAPT Therapeutics Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "RAPT Therapeutics...today reported financial results for the second quarter and six months ended June 30, 2024.'We continue to analyze the data from our two Phase 2 trials of zelnecirnon (RPT193) in atopic dermatitis and asthma, which we closed prior to completing enrollment following the clinical holds placed by the FDA in February' 'We anticipate that our analysis of the data will be completed this quarter.'"

P2 data • Asthma • Atopic Dermatitis • Dermatitis • Immunology • Respiratory Diseases

Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (clinicaltrials.gov) - P2 | N=38 | Terminated | Sponsor: RAPT Therapeutics, Inc. | N=100 ➔ 38 | Trial completion date: Aug 2025 ➔ Jun 2024 | Suspended ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Jun 2024; Study on clinical hold by FDA

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=229 | Terminated | Sponsor: RAPT Therapeutics, Inc. | Trial completion date: Sep 2024 ➔ May 2024 | Suspended ➔ Terminated; Study on clinical hold by FDA

Monotherapy • Trial completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

RAPT Therapeutics Reports First Quarter 2024 Financial Results (GlobeNewswire) - "The Company also announced today that it has decided to close and unblind both its Phase 2b clinical trial of zelnecirnon (RPT193) in atopic dermatitis ('AD') and its Phase 2a trial of zelnecirnon in asthma. Both clinical trials were placed on clinical hold by the FDA in February 2024 based on a serious adverse event of liver failure requiring transplant in one patient in the AD trial. Prior to the imposition of the clinical hold, a total of 229 patients had been enrolled in the Phase 2b AD trial, of which approximately 110 had completed the 16-week dosing period."

Enrollment closed • Trial suspension • Asthma • Atopic Dermatitis • Immunology

RAPT Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "RAPT Therapeutics, Inc...reported financial results for the fourth quarter and year ended December 31, 2023...Research and development expenses for the fourth quarter of 2023 were $26.8 million, compared to $19.5 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to zelnecirnon, as well as increased expenses for personnel, lab supplies, consultants, facilities and stock-based compensation, partially offset by lower development costs related to tivumecirnon and early-stage programs...Research and development expenses for the year ended December 31, 2023 were $101.0 million, compared to $67.1 million in 2022. The increase in research and development expenses was primarily due to higher development costs related to zelnecirnon....partially offset by lower development costs related to tivumecirnon and early-stage programs."

Commercial • Asthma • Hematological Malignancies • Immunology • Inflammation • Oncology • Respiratory Diseases • Solid Tumor

An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=268 | Suspended | Sponsor: RAPT Therapeutics, Inc. | Recruiting ➔ Suspended

Monotherapy • Trial suspension • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (clinicaltrials.gov) - P2 | N=100 | Suspended | Sponsor: RAPT Therapeutics, Inc. | Recruiting ➔ Suspended

Trial suspension • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

RAPT Therapeutics Announces Clinical Hold on Studies Evaluating Zelnecirnon (GlobeNewswire) - "RAPT Therapeutics, Inc...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....Dosing of zelnecirnon has been halted in both clinical trials, as has enrollment of new trial participants."

Trial suspension • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Zelnecirnon: "Zelnecirnon differentiated from placebo on EASI and EASI-50 at day 29 with further improvement at day 43"; Atopic dermatitis (RAPT Therapeutics) - Corporate Presentation: "Overall safety profile suggests a well-tolerated oral drug that should not require laboratory safety monitoring"

P1 data • Atopic Dermatitis • Immunology

Zelnecirnon: “Zelnecirnon can be commercially successful across a broad range of efficacy“ (RAPT Therapeutics) - Corporate Presentation

Commercial • Atopic Dermatitis • Immunology

Innovaderm, a Key Collaborator in Clinical and Study Development for Recently Published Phase 1 Atopic Dermatitis Study (Businesswire) - "Allergy recently published RAPT Therapeutics’ phase 1a/1b atopic dermatitis (AD) study, in which Innovaderm Research was a key partner, serving as the contract research organization (CRO). This was a first-in-human and proof of concept randomized, placebo-controlled Phase 1a/1b monotherapy study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and CCR4 surface receptor occupancy of zelnecirnon (formerly RPT193) in eligible healthy subjects and subjects with moderate-to-severe AD."

Licensing / partnership • Atopic Dermatitis • Dermatology • Immunology

Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: RAPT Therapeutics, Inc.

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=268 | Recruiting | Sponsor: RAPT Therapeutics, Inc.

Monotherapy • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of RPT193 in Healthy Adult Male Subjects (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: RAPT Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Trial completion date

RAPT Therapeutics Announces Publication of Phase 1a/1b Clinical Trial of Zelnecirnon (RPT193) to Treat Atopic Dermatitis in Allergy (GlobeNewswire) - P1 | N=103 | NCT04271514 | Sponsor: RAPT Therapeutics, Inc. | "RAPT Therapeutics, Inc...announced that results from its previously disclosed Phase 1a/1b clinical trial of zelnecirnon (formerly RPT193) were published in Allergy....The findings showed that once-daily zelnecirnon treatment was generally well tolerated, with no serious adverse events reported, and all reported treatment-emergent adverse events were mild-to-moderate in nature across both patients with atopic dermatitis and healthy volunteers. In the Phase 1b trial, after four weeks of treatment, patients with moderate-to-severe AD who received zelnecirnon showed a 36.3% change from baseline in the Eczema Area and Severity Index (EASI) score, a standard measure of disease severity, compared to 17.0% in the placebo group....'We look forward to reporting top-line data from our Phase 2b trial in atopic dermatitis in mid-2024 and continuing to progress enrollment in our Phase 2a trial in asthma.'"

Enrollment status • P1 data • P2b data • Asthma • Atopic Dermatitis • Dermatitis • Immunology • Respiratory Diseases

Clinical and molecular effects of oral CCR4 antagonist RPT193 in atopic dermatitis: A Phase 1 study. (PubMed, Allergy) - P1 | "To our knowledge, this is the first clinical study with an oral CCR4 antagonist that showed clinical improvement coupled with modulation of the cutaneous transcriptomic profile in an inflammatory skin disease."

IO biomarker • Journal • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CCR4

Treatment with the oral CCR4 antagonist RPT193 results in meaningful changes in cutaneous biomarkers detected by transcriptomic profiling of tape strips (ISDS 2023) - P2 | "RPT193 induced significant changes in AD-related biomarkers in tape-stripped AD skin after 4 weeks of treatment. Transcriptional changes correlated with biopsy RNA-seq data and improved clinical metrics. These data suggest that RPT193 treatment improves the AD skin transcriptome, consistent with observed clinical efficacy and with decreases in CCR4 expression in the skin and on circulating Th2 cells."

Biomarker • IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CCR4 • IL13 • IL22 • IL2RA • IL32 • S100A12 • S100A9 • TSLP

Study of RPT193 in Healthy Adult Male Subjects (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: RAPT Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Study of RPT193 in Healthy Adult Male Subjects (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: RAPT Therapeutics, Inc.

New P1 trial

RAPT Therapeutics Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "'We continue to remain focused on our Phase 2 trials for RPT193 in atopic dermatitis (AD) and asthma. We anticipate reporting top-line data from our Phase 2b trial in AD in mid-2024 and we continue to enroll our Phase 2a trial in asthma...'"

P2b data • Trial status • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Respiratory Diseases

Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: RAPT Therapeutics, Inc.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Potent and selective oral CCR4 antagonist RPT193 for treatment of allergic disorders (ACS-Fall 2023) - "RPT193 has successfully completed Phase 1 clinical trials where it has demonstrated good exposure and receptor occupancy after oral dosing and has shown evidence of efficacy and biomarker changes in a Phase 1b trial in patients with moderate to severe atopic dermatitis. The drug is currently in Phase 2 clinical studies for atopic dermatitis and asthma."

IO biomarker • Allergy • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases • CCL2 • CCL22 • CCR4

An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=268 | Recruiting | Sponsor: RAPT Therapeutics, Inc. | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Monotherapy • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology