RAPT Therapeutics Announces FDA Clearance of IND Application to Proceed to Phase 2b Trial of RPT904 in Food Allergy
RAPT Therapeutics (Nasdaq: RAPT) has received FDA clearance for its Investigational New Drug (IND) Application to proceed with a Phase 2b clinical trial of RPT904 for food allergy treatment. The trial will be a randomized, double-blind, placebo-controlled study evaluating RPT904's safety and efficacy with dosing intervals of 8 and 12 weeks.
The company plans to initiate the trial by the end of 2025. RPT904 is RAPT's next-generation, half-life extended anti-IgE molecule. Additional data from RAPT's Chinese partner Jeyou's Phase 2 trials in chronic spontaneous urticaria and asthma is expected by year-end.
RAPT Therapeutics (Nasdaq: RAPT) ha ottenuto l'autorizzazione FDA per la sua domanda IND (Investigational New Drug) per procedere con uno studio clinico di fase 2b di RPT904 per il trattamento delle allergie alimentari. lo studio sarà randomizzato, in doppio cieco, controllato con placebo, e valuterà la sicurezza e l'efficacia di RPT904 con intervalli di dosaggio di 8 e 12 settimane.
L'azienda prevede di iniziare lo studio entro la fine del 2025. RPT904 è la molecola anti-IgE di nuova generazione a emivita prolungata di RAPT. Ulteriori dati dal partner cinese Jeyou sui trial di fase 2 in orticaria cronica spontanea e asma dovrebbero arrivare entro la fine dell'anno.
RAPT Therapeutics (Nasdaq: RAPT) ha recibido la aprobación de la FDA para su solicitud de Investigational New Drug (IND) para avanzar con un ensayo clínico de fase 2b de RPT904 para el tratamiento de alergias alimentarias. El ensayo será aleatorizado, doble ciego, controlado con placebo, y evaluará la seguridad y la eficacia de RPT904 con intervalos de dosificación de 8 y 12 semanas.
La compañía planea iniciar el ensayo a finales de 2025. RPT904 es la molécula anti-IgE de próxima generación de RAPT con vida media prolongada. Se esperan datos adicionales del socio chino Jeyou de los ensayos de fase 2 en urticaria crónica espontánea y asma para finales de año.
RAPT Therapeutics (나스닥: RAPT)가 식품 알레르기 치료를 위한 RPT904의 2b상 임상 시험을 진행하기 위한 FDA IND 승인을 받았습니다. 이 시험은 무작위 배정, 이중 맹검, 위약 대조 연구로 이루어지며 RPT904의 안전성과 효과를 평가하며 8주와 12주의 투여 간격으로 진행됩니다.
회사는 2025년 말까지 시험을 시작할 계획입니다. RPT904는 RAPT의 차세대 반감기 연장 항-IgE 분자입니다. 중국 파트너인 제요우(Jeyou)의 2상 데이터가 만년말까지 추가로 발표될 것으로 기대됩니다.
RAPT Therapeutics (Nasdaq : RAPT) a reçu l’autorisation de la FDA pour sa demande IND (Investigational New Drug) afin de mener un essai clinique de phase 2b pour le traitement des allergies alimentaires. L’essai sera randomisé, en double aveugle et contrôlé par placebo, et évaluera la sécurité et l’efficacité de RPT904 avec des intervalles de dosage de 8 et 12 semaines.
L’entreprise prévoit de lancer l’essai d’ici la fin 2025. RPT904 est la molécule anti-IgE de prochaine génération à demi-vie prolongée de RAPT. Des données supplémentaires du partenaire chinois Jeyou issus des essais de phase 2 sur l’urticaire chronique spontanée et l’asthme devraient être publiées d’ici la fin de l’année.
RAPT Therapeutics (Nasdaq: RAPT) hat die FDA-Zulassung für seinen IND-Antrag erhalten, um mit einer Phase-2b-Studie von RPT904 zur Behandlung von Lebensmittelallergien fortzufahren. Die Studie wird eine randomisierte, doppelt-blinde, placebokontrollierte Untersuchung sein, die die Sicherheit und Wirksamkeit von RPT904 mit Dosierungsintervallen von 8 und 12 Wochen bewertet.
Das Unternehmen plant, das Studium bis Ende 2025 zu beginnen. RPT904 ist das nächste Generation, halbwertszeitverlängerte Anti-IgE-Molekül von RAPT. Erwartet werden weitere Daten von RAPTs chinesischem Partner Jeyou aus Phase-2-Studien zu chronischer spontaner Urtikaria und Asthma bis Jahresende.
RAPT Therapeutics (ناسداك: RAPT) تلقّت موافقة FDA على طلب IND الخاص بها للمضي قدمًا في تجربة سريرية من المرحلة 2b لتقييم RPT904 لعلاج حساسية الطعام. ستكون التجربة عشوائية، مزدوجة التعمية، محكومة بالدواء الوهمي، وتقيِّم السلامة والفعالية لـ RPT904 بفواصل جرعات 8 و12 أسبوعًا.
تخطط الشركة للبدء في التجربة بنهاية عام 2025. RPT904 هو جزيء مضاد IgE من الجيل التالي ذو نصف عمر ممتد. من المتوقع أن تأتي بيانات إضافية من الشريك الصيني Jeyou من تجارب المرحلة 2 في الشرى المستمر المزمن والربو بحلول نهاية العام.
RAPT Therapeutics (纳斯达克：RAPT) 已获得 FDA 就其 Investigational New Drug (IND) 申请的批准，以推进对 2b 期临床试验的 RPT904，用于治疗食物过敏。该试验将是一项随机、双盲、安慰剂对照的研究，评估 RPT904 的安全性和有效性，给药间隔为 8 周和 12 周。
公司计划 在 2025 年底前启动试验。RPT904 是 RAPT 的下一代、半衰期延长的抗 IgE 分子。预计来自中国合作伙伴杰友（Jeyou）的 2 期在慢性自发性荨麻疹和哮喘方面的其他数据将于年内公布。
- FDA clearance received for Phase 2b trial advancement
- Trial initiation on track for end of 2025
- Additional Phase 2 data expected from partner Jeyou in two indications by year-end
- Potential to address large, underserved food allergy market
- None.
RAPT on track to initiate trial this year
SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with food allergy. The planned Phase 2b trial in food allergy is a randomized double-blind placebo-controlled study designed to evaluate the safety and efficacy of RPT904 dosed every 8 weeks (Q8W) and every 12 weeks (Q12W).
“Clearance of our IND application, which included data from our Chinese partner Jeyou, is an important and meaningful step for the program,” said Brian Wong, M.D., Ph.D., President and CEO of RAPT. “We are excited to advance clinical development of RPT904, our next-generation, half-life extended anti-IgE molecule with a differentiated product profile. We are on track to initiate our Phase 2b clinical trial by the end of the year, taking us closer to our objective of delivering a best-in-class therapeutic option to patients in the large and underserved food allergy community. Furthermore, we look forward to data from Jeyou’s Phase 2 trials in chronic spontaneous urticaria and asthma, which we also expect by the end of the year.”
About the RPT904-01 (prestIgE) Phase 2b Trial
The Phase 2b trial, named “prestIgE”, is designed to assess the efficacy and safety of RPT904 monotherapy in participants with IgE-mediated food allergy. The two-part, multi-center, randomized, double-blind, placebo-controlled study will compare two dosing regimens of RPT904 (administered subcutaneously every 8 weeks or every 12 weeks, including a loading dose at Week 2) to placebo in a 2:2:1 ratio. In Part 1, approximately 100 participants with at least one food allergy (peanut, milk, egg, walnut or cashew) will be treated for 24 weeks. The primary endpoint for the trial is the proportion of participants who achieve a prespecified target threshold at a double-blind, placebo-controlled, oral food challenge (DBPCFC) at Week 24. In Part 2, the participants in the RPT904 treatment arms will continue treatment for another 24 weeks, while participants on placebo will be re-randomized 1:1 to receive RPT904 either every 8 weeks or every 12 weeks (with a loading dose at Week 26) through Week 48 and all participants will undergo a DBPCFC at Week 48. Participants will also be followed for an additional 16 weeks in a safety follow-up period.
About RPT904
RPT904 is a novel, half-life extended anti-IgE bio-better monoclonal antibody (mAb) targeting the same epitope as omalizumab for the treatment of patients with food allergies, chronic spontaneous urticaria and other allergic inflammatory diseases. RPT904 is designed to inhibit free and cell-bound human immunoglobulin E (IgE), a key driver of allergic diseases, and in early clinical studies has demonstrated extended pharmacokinetics and pharmacodynamic properties compared to omalizumab, a first generation anti-IgE mAb.
About RAPT Therapeutics, Inc.
RAPT is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases. Utilizing our deep and proprietary expertise in immunology, we develop novel therapies that are designed to modulate the critical immune responses underlying these diseases.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimates,” “expects,” “look forward,” “on track,” “planned,” “potential” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the development of RPT904, regulatory interactions, the therapeutic and commercial potential of RPT904, the design and timing of clinical trials and the availability of data therefrom, and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, our reliance on our partners and other third parties, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission (SEC) on August 7, 2025, and subsequent filings made by RAPT with the SEC. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements, except as required by law.
RAPT Investor Contact:
Sylvia Wheeler
swheeler@wheelhouselsa.com
RAPT Media Contact:
Aljanae Reynolds
areynolds@wheelhouselsa.com
FAQ
What did the FDA approve for RAPT Therapeutics (RAPT) in September 2025?
When will RAPT Therapeutics start the Phase 2b trial for RPT904?
What is RPT904 and how is it administered to patients?
What additional clinical trial results is RAPT expecting in 2025?
What type of study design is RAPT using for the Phase 2b trial of RPT904?
