BACKGROUND

PrEP-001 Nasal Powder, a proprietary formulation of polyriboinosinic and polyribocytidylic acid effectively elicits a cellular innate immune response in nasal epithelium. The aim of these 2 studies was to investigate the safety and efficacy of PrEP-001 prophylaxis against rhinovirus (HRV-A16) and influenza-A (H3N2-IAV).

METHODS

Healthy subjects randomly received 2 doses of PrEP-001 or placebo, 48 and 24 h pre-challenge with 10 TCID₅₀ of HRV-A16 (Study 1) or H3N2-IAV (Study 2).

RESULTS

In Study 1, PrEP-001 reduced median total symptom score from 38.5 to 4.5 (p = 0.004), median symptom duration from 6.0 to 1.7 days and median mucus production from 15 g to 3 g. The percentage of subjects classified as ill was reduced 3-fold (placebo 73%, PrEP-001 23%, p = 0.002). In Study 2, PrEP-001 reduced median total symptom score from 8.0 to 4.1 (p = 0.021), median symptom duration from 4.6 to 3.7 days and median mucus production from 3.6 g to 1.5 g. The percentage of subjects classified as ill was reduced 2-fold (placebo 48%, PrEP-001 24%, p = 0.064). PrEP-001 reduced peak viral shedding in both studies, as assessed by qRT-PCR of nasal lavage. Seroconversion rates were comparable between placebo and PrEP-001 (Study 1: 77% [both arms]; Study 2: placebo 73%, PrEP-001 80%). PrEP-001 was well-tolerated, with no clinically significant adverse events.

CONCLUSIONS

PrEP-001 reduced the number of individuals with clinical illness and attenuated severity and duration of HRV-A16 and H3N2-IAV infections without compromising seroconversion, and was well-tolerated. This supports further evaluation of PrEP-001 as a potential pan-viral prophylaxis for upper respiratory tract infections.

CLINICAL TRIAL REGISTRATION

Study 1, HRV-A16 study: EudraCT Number 2012-005579-14 (study conducted before ClinicalTrials.gov registration required). Study 2, H3N2-IAV study: EudraCT Number 2015-002895-26 and ClinicalTrials.gov: NCT03220048.

中文翻译：

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PrEP-001对鼻病毒和流感病毒的预防作用-2项随机试验结果

背景

PrEP-001鼻粉，一种多核糖苷酸和一种多核糖基酸的专有配方，可在鼻上皮细胞中有效引发细胞的先天免疫反应。这两项研究的目的是研究预防鼻病毒（HRV-A16）和甲型流感（H3N2-IAV）的PrEP-001的安全性和有效性。

方法

健康受试者在攻击前48小时和24小时随机接受2剂PrEP-001或安慰剂和10 TCID ₅₀的HRV-A16（研究1）或H3N2-IAV（研究2）。

结果

在研究1中，PrEP-001将中位数总症状评分从38.5降低到4.5（p = 0.004），中位症状持续时间从6.0降低到1.7天，中位数粘液产生从15 g降低到3 g。被归类为疾病的受试者的百分比降低了3倍（安慰剂73％，PrEP-001 23％，p = 0.002）。在研究2中，PrEP-001将中位数总症状评分从8.0降低到4.1（p = 0.021），中位症状持续时间从4.6降低到3.7天，中位数粘液产生从3.6 g降低到1.5 g。被归类为疾病的受试者的百分比降低了2倍（安慰剂48％，PrEP-001 24％，p = 0.064）。通过qRT-PCR鼻灌洗法评估，PrEP-001在两项研究中均降低了峰值病毒脱落。安慰剂和PrEP-001之间的血清转化率相当（研究1：77％（两臂）；研究2：安慰剂73％，PrEP-001 80％）。PrEP-001具有良好的耐受性，

结论

PrEP-001减少了患有临床疾病的人数，并减少了HRV-A16和H3N2-IAV感染的严重程度和持续时间，同时又不影响血清转换，并且耐受性良好。这支持进一步评估PrEP-001作为上呼吸道感染的潜在全病毒预防药物。

临床试验注册

研究1，HRV-A16研究：EudraCT号2012-005579-14（在需要ClinicalTrials.gov注册之前进行的研究）。研究2，H3N2-IAV研究：EudraCT号2015-002895-26和ClinicalTrials.gov：NCT03220048。