Avalo Therapeutics，Inc (Nasdaq: AVTX) today announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the Company to commence its Phase 2 (LOTUS) clinical trial in patients with HS. Avalo expects to enroll the first patient in its Phase 2 LOTUS Trial this year.

Avalo Therapeutics，Inc（纳斯达克股票代码：AVTX）今天宣布，用于治疗化脓性汗腺炎（HS）的抗IL-1β单克隆抗体（mAb）AVTX-009的研究新药（IND）现已上市，允许该公司开始对HS患者进行2期（LOTUS）临床试验。Avalo预计今年将在其2期LOTUS试验中招募第一名患者。

“This active IND is an important step for commencing the LOTUS trial in patients with hidradenitis suppurativa. I am proud of the Avalo team for achieving this milestone in just over three months from acquiring the product candidate in late March 2024,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board.

首席执行官兼董事会主席加里·尼尔博士说：“这项积极的IND是开始化脓性汗腺炎患者LOTUS试验的重要一步。我为Avalo团队在2024年3月底获得候选产品后的短短三个多月内实现这一里程碑感到骄傲。”。

“We believe that AVTX-009 has the potential to be best-in-class and best-in-indication because of its target, half-life, and potency, which may allow for strong efficacy and convenient dosing, and we look forward to getting the LOTUS Trial underway.” The LOTUS Trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe HS.

“我们认为AVTX-009具有成为同类最佳和适应症最佳的潜力，因为它的目标，半衰期和效力可能会产生强大的疗效和方便的剂量，我们期待着进行LOTUS试验。”LOTUS试验是一项随机，双盲，安慰剂对照，平行组2期试验，采用两种AVTX-009剂量方案，评估AVTX-009在大约180名中重度HS成人中的疗效和安全性。

The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Subjects will be randomized (1:1:1) to receive either one of two doses of AVTX-009 or placebo. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic inflammatory ski.

主要疗效终点是在第16周达到化脓性汗腺炎临床反应（HiSCR75）的受试者比例。受试者将被随机（1:1:1）接受两剂AVTX-009或安慰剂中的一剂。关于化脓性汗腺炎化脓性汗腺炎（HS）是一种慢性炎症。