RAPT Therapeutics announces – GuruFocus.com
SOUTH SAN FRANCISCO, Calif., May 23, 2022 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (RAPT), a clinical-stage immunology-based biopharmaceutical company focused on the discovery, development and commercialization of therapeutics oral small molecule drugs for patients with high unmet need in inflammatory diseases and oncology, today announced the initiation of its 16-week, randomized, double-blind, placebo-controlled Phase 2b clinical trial for further assess the efficacy and safety of RPT193 monotherapy in patients with moderate to severe atopic dermatitis (AD).
“We are excited to advance RPT193 into this Phase 2b trial in atopic dermatitis,” said Brian Wong, MD, Ph.D., President and CEO of RAPT. “The results of our phase 1b trial confirm the potential of RPT193 as a safe, once-daily oral treatment for AD that would be an attractive therapeutic alternative to injectable medications. Additionally, the clinical results were supported by our recently reported biomarker data. We are encouraged by the potential of RPT193 for patients with AD and other inflammatory diseases and plan to expand the development of RPT193 into a Phase 2a trial in asthma in the second half of this year.
Last year, RAPT reported that in the Phase 1b trial, RPT193 demonstrated a clear advantage over placebo in key exploratory efficacy measures at the end of the four-week treatment period (Day 29 ), including the Eczema Area and Severity Index (EASI) score, validated Investigator’s Global Assessment (vIGA), Numerical Pruritus Rating Scale (NRS), and Body Surface Area (BSA). At the end of the study, which included a two-week follow-up period (Day 43), RPT193 demonstrated improvement in EASI, EASI-50, EASI-75, EASI -90, vIGA and BSA. In a post-hoc statistical analysis comparing RPT193-treated patients to placebo-treated patients, improvements in EASI, EASI-50, and BSA at Day 43 were statistically significant. RPT193 was well tolerated in the phase 1b study. No serious adverse events were reported and all reported adverse events were mild or moderate in intensity. In March 2022, biomarker data from the Phase 1b trial presented at the American Academy of Dermatology Annual Meeting demonstrated statistically significant improvements in the skin transcriptomic profile of RPT193-treated patients, correlating with key efficiency measures.
About the Phase 2b trial of RPT193
The US-based Phase 2b trial is designed to evaluate the efficacy and safety of multiple doses of RPT193 monotherapy in patients with moderate to severe AD. The randomized, double-blind, placebo-controlled study will compare three oral dose levels of RPT193 (50, 200, and 400 mg once daily) to placebo with a treatment duration of 16 weeks. The co-primary endpoints of the trial are percent change in EASI from baseline at week 16 and incidence of treatment-emergent adverse events. Key secondary endpoints include percentage of patients achieving a vIGA score of 0 or 1 at week 16, percentage of patients achieving EASI-75, defined as a 75% reduction in EASI from baseline and week 16, and percent change from baseline in the Pruritus Peak Numerical Rating Scale (PP-NRS) from a daily electronic itch diary at week 16. Additionally, being since the maximum clinical benefit in the four-week phase 1b trial was observed two weeks after discontinuation of treatment, patients in the trial will be followed for an additional eight weeks beyond the 16-week treatment period to understand if sustained responses and/or further improvement in clinical parameters are observed beyond the treatment period.
RPT193 is an oral small molecule therapy in development for the treatment of atopic dermatitis and other inflammatory diseases. RPT193 is designed to selectively inhibit Th2 cell migration into inflamed tissue by blocking CCR4, a receptor highly expressed on Th2 cells. Preclinical data suggest that RPT193 also has the potential to modulate Th2 cell function by lowering Th2 cytokine secretion upon stimulation. In allergic inflammatory diseases such as AD, chemokines recruit Th2 cells via CCR4 to inflamed tissues, where Th2 cells secrete proteins known to drive the inflammatory response. The role of Th2 cells has been clinically validated by injectable biologics targeting this pathway. AD patients express higher levels of CCR4 ligands compared to healthy humans; these ligands also correlate with disease severity. RAPT believes that by inhibiting CCR4, RPT193 has the potential to provide therapeutic benefit to patients in a wide range of inflammatory diseases, including AD, asthma, chronic spontaneous urticaria, allergic rhinitis with nasal polyps , chronic rhinosinusitis and eosinophilic esophagitis.
About atopic dermatitis
Atopic dermatitis is a widespread chronic inflammatory skin disease characterized by a breakdown of the skin barrier and immune dysregulation. Patients with Alzheimer’s disease present with chronically inflamed skin lesions that can cause debilitating pruritus (itching), which can severely impair quality of life. Although there is a marketed injectable product for the treatment of AD, RAPT believes that RPT193, if approved, could address an unmet medical need for the treatment of inflammatory disorders with the convenience of oral administration. once a day. There are approximately 19 million adults and approximately 10 million children affected by AD in the United States.
About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical-stage immunology-based biopharmaceutical company focused on the discovery, development and commercialization of oral small molecule therapies for patients with high unmet needs in inflammatory diseases and oncology . Using its proprietary discovery and development engine, the company develops highly selective small molecules designed to modulate the critical immune factors underlying these diseases. RAPT has discovered and developed two unique drug candidates, RPT193 and FLX475, each targeting the CC motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively. The company is also pursuing a range of targets that are in the discovery stage of development.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Similar expressions (and other words or phrases referring to future events, conditions or circumstances) are intended to identify statements prospective. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that could cause our actual results, performance or achievements to be materially different from any future performance or achievement expressed or implied by the forward-looking statements. Each of these statements is based solely on current information, assumptions and expectations which are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, the design of the Phase 2b trial of RPT193 in atopic dermatitis, clinical development progress, including the planned advancement of RPT193 to a Phase 2a trial in the asthma or other indications, and the potential of RPT193 to treat AD or other inflammatory diseases. Many factors could cause current expectations to differ from actual results, including unexpected safety or efficacy data observed during clinical studies, preliminary data, and trends may not be predictive of the data or future results, may not demonstrate safety or efficacy or lead to regulatory approval, clinical results less than expected, unanticipated, or greater impact or delays due to trial site activation or enrollment rates to the COVID-19 pandemic, changes in anticipated or existing competition, changes in the regulatory environment, uncertainties and timing of the regulatory approval process, and the adequacy of RAPT’s liquidity. Detailed information regarding the risk factors that could cause actual results to differ materially from the results expressed or implied by the statements in this press release can be found in RAPT’s Quarterly Report on Form 10-Q. filed with the Securities and Exchange Commission on May 11, 2022, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.