CDI的研究疗法取得积极成果

StephenW

Investigational Therapy for CDI has Positive Results
JUN 23, 2020 | JOHN PARKINSON
Somerville, MA-based Finch Therapeutics Group announced positive results for its investigational oral microbiome drug, CP101, from its PRISM3 trial. CP101 was developed for the prevention of recurrent C. difficile infection (CDI).

PRISM3, is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial. The trial used 206 randomized patients with recurrent CDI at 51 sites across the US and Canada.

The drug met the primary efficacy endpoint in PRISM3, with 74.5% of recurrent CDI patients who received a single administration of CP101 achieving a sustained clinical cure through week 8. This was a statistically significant improvement in comparison to 61.5% of patients in the control group who received standard-of-care antibiotic therapy alone (p < 0.05).

"These results are very encouraging and show that CP101 has the potential to fulfill the need for an oral drug that breaks the cycle of CDI recurrence, preventing the devastating effects of recurrent C. difficile infections on patients’ lives,” Jessica Allegretti, MD, MPH, principal investigator in the PRISM3 clinical trial said. “This validates the approach of microbiome restoration and is a critical milestone for the field, opening the potential to develop this class of therapy for many other conditions arising from disruption of the microbiome.”

After patients achieved a sustained clinical cure, they are being followed for 16 weeks for additional safety and efficacy endpoints.

The US Food and Drug Administration (FDA) granted CP101 a Breakthrough Therapy Designation in February of 2019. The Breakthrough Therapy Designation is intended to expedite the development and review of investigational therapeutics for areas of unmet need when preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies.

In addition, Finch announced its plans to evaluate CP101 for the chronic hepatitis B treatment. There is clinical evidence that demonstrates hepatitis B virus e-antigen clearance following microbiome restoration, even among patients that have failed to achieve clearance following long-term antiviral therapy.
The company intends to study if CP101 may restore the microbiome and support activation of an immune response in chronic hepatitis B patients.

“We plan to apply the same principles we used in CDI against the many other conditions linked to microbiome dysfunction,” Finch CEO Mark Smith said in an announcement. “As an important next step towards this vision, we are announcing today a new development program for CP101 in the treatment of chronic hepatitis B.”   

StephenW

CDI的研究疗法取得积极成果
2020年6月23日|约翰·帕金森
总部位于马萨诸塞州萨默维尔的芬奇治疗集团（Finch Therapeutics Group）宣布，其PRISM3试验的口服微生物组研究药物CP101取得了积极成果。 CP101被开发用于预防复发性艰难梭菌感染（CDI）。

PRISM3是一项多中心，随机，双盲，安慰剂对照的2期临床试验。该试验在美国和加拿大的51个地点使用了206名随机分配的CDI复发患者。

该药物达到PRISM3的主要疗效终点，单次使用CP101的CDI复发患者中有74.5％的患者在第8周内获得了持续的临床治愈。与对照组的61.5％的患者相比，该药物具有统计学意义的改善仅接受护理标准抗生素治疗的患者（p <0.05）。

医学博士Jessica Allegretti表示：“这些结果令人鼓舞，表明CP101有潜力满足对口服药物的需求，该药物可打破CDI复发的周期，防止复发性艰难梭菌感染对患者生活的破坏性影响。 PRISM3临床试验的主要研究者MPH说：“这验证了微生物组修复的方法，是该领域的关键里程碑，为开发这种类型的疗法用于微生物组破坏引起的其他许多疾病打开了潜力。”

患者获得持续的临床治愈后，将被随访16周以提高安全性和有效性。

美国食品药品监督管理局（FDA）于2019年2月授予CP101突破性治疗称号。当初步临床证据表明该产品可能证明有待满足时，突破性治疗称号旨在加快针对未满足需求领域的研究性治疗剂的开发和审查。对现有疗法的实质性改进。

此外，芬奇宣布计划评估CP101的慢性乙型肝炎治疗。有临床证据表明，即使在长期抗病毒治疗后仍未清除病毒的患者中，微生物组恢复后仍可清除乙肝病毒电子抗原。
该公司打算研究CP101是否可以恢复微生物组并支持慢性乙型肝炎患者的免疫应答激活。

Finch首席执行官马克·史密斯（Mark Smith）在一份声明中说：“我们计划将CDI中使用的相同原理用于与微生物组功能障碍相关的许多其他情况。” “作为实现这一愿景的重要的下一步，我们今天宣布一项新的CP101开发计划，用于治疗慢性乙型肝炎。”