VLP Peanut PROTECT 평가판 업데이트
알레르기 치료 plc
("알레르기 치료제", "ATL" 또는 "그룹")
Allergy Therapeutics commences subcutaneous dosing in peanut allergic
patients in Phase I/IIa VLP Peanut PROTECT Trial
- First patient receives subcutaneous dosing with no safety signals observed
- Subjects will receive a total of three escalating doses over three separate dosing days
- This marks the start of the clinical proof of concept phase using biomarkers to assess preliminary efficacy
- No safety signals observed in the cohorts treated to date
- In addition, having already demonstrated tolerability of a 25-fold dose increase in 2 cohorts of healthy subjects, dose escalation in healthy subjects has progressed to a third cohort to pave the way for dose escalation to similar strengths in peanut allergic patients
월 12 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces the commencement of subcutaneous dosing of peanut allergic patients in the Phase I/IIa PROTECT trial evaluating its novel virus-like particle (VLP)-based peanut allergy vaccine candidate ("VLP Peanut").
Patients allergic to peanuts have previously undergone skin-prick testing in part A of the PROTECT trial. Following an external safety review committee (SRC), it was determined that no safety signals had been observed and it was safe to proceed with incremental subcutaneous dosing in healthy subjects in the Phase I stage and in peanut allergic patients in the Phase IIa part of the trial.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "This is a key milestone in our journey to offer transformative outcomes to patients living with peanut allergies. We are excited to begin gathering data supportive of efficacy using biomarker technology which is aligned with recent FDA workshop thinking on demonstrating efficacy in clinical trials. We look forward to the complete results of this trial and continue to work towards the required planning for the phase II."
The PROTECT trial is being conducted in both healthy volunteers and peanut allergic patients and consists of Part A and Part B. Part A involves subcutaneous immunotherapy (SCIT) dosing in healthy volunteers (Group A1) and skin-prick testing in peanut allergic patients (Group A2), the latter of which was completed in April 2023.
Part B of the clinical trial is double-blind, placebo-controlled and has commenced in subjects with peanut allergy at multiple clinical trial sites in the US. Up to 36 peanut-allergic subjects will be enrolled in Part B of the clinical trial, should the dosing advance to the highest dose as currently planned.
The Group will announce trial updates as is appropriate.
More information about the PROTECT trial can be found on ClinicalTrials.gov 식별자 아래 NCT05476497.
This announcement contains inside information for the purposes of Article 7 of the UK Market Abuse Regulations.
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자세한 내용은 문의하시기 바랍니다 :
알레르기 치료제
마누엘 로벳(Manuel Llobet) 최고경영자(CEO)
Shaun Furlong, 최고 재무 책임자
+44 (0)1903 845 820
Panmure Gordon(지명 고문 및 Broker)
Emma Earl, Freddy Crossley, Mark Rogers, 기업 금융
Rupert Dearden, 기업 중개
+44 (0)20 7886 2500
ICR 콘실리움
메리 제인 엘리엇 / 데이빗 데일리 / 데이빗 살비
+44 (0)20 3709 5700
편집자 참고 사항 :
알레르기 치료제에 대하여
Allergy Therapeutics는 영국에 본사를 두고 있는 국제 상업 생명공학 회사로, 질병을 치료할 수 있는 가능성이 있는 무알루미늄 면역요법 백신을 포함하여 알레르기 질환의 치료 및 진단에 중점을 두고 있습니다. 그룹은 XNUMX개의 주요 유럽 국가에 있는 자회사와 추가 XNUMX개 국가에서 유통 계약을 통해 독점 및 제XNUMX자 제품을 판매합니다. 임상 개발 중인 광범위한 제품 파이프라인에는 잔디, 나무, 집 먼지 진드기 및 땅콩에 대한 백신이 포함됩니다. 자세한 내용은 다음을 참조하십시오. www.allergytherapeutics.com.
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