2020年4月28日

Avalyn制药公司,生物制药公司专注于发展改进治疗危及生命的肺部疾病,今天宣布完成系列B融资3550万美元。圆是由西北银行合资企业伙伴一起参与新投资者关键bioVenture伙伴,和现有投资者f '资本,新生控股/ S, RiverVest Venture Partners, TPG生物技术。并发与融资,风险投资家罗伯特•Mittendorff医学博士加入董事会。Avalyn刚刚完成注册在雾化剂治疗方案的临床研究pirfenidone (AP01)患者的特发性肺纤维化(IPF)。所得系列B扩大公司的管道,将支持II / III期临床试验的启动AP01慢性肺部的同种异体移植物功能障碍(复合),最常见的移植失败这发生在超过50%的肺移植受者移植后的5年内,导致re-transplant或死亡。此外,基金将支持一个阶段我研究AP02,雾化nintedanib,程序后进入临床开发成功的临床前研究在两肺损伤模型。“申论系统性药物靶向吸入肺交付已经成功地提高了疗效和降低系统性皮质类固醇的副作用和在哮喘和慢性阻塞性肺病、支气管扩张剂和囊性纤维化的抗生素,“a·布鲁斯·蒙哥马利博士说Avalyn制药公司的首席执行官。“尽管2014年批准的两个口头antifibrotic疗法,IPF和其他肺纤维化疾病与大量的未满足的需求仍然是致命的疾病。我们希望完成改进的耐受性和疗效与雾化pirfenidone nintedanib。我们很高兴通过安全概要文件我们已经看到雾化pirfenidone近100名患者。” About Avalyn Pharma Clinical Need IPF and other fibrotic lung diseases are characterized by progressive scarring, reduced exercise capacity and ultimate death from respiratory failure and/or co-morbidities. IPF treatments are relatively new, with the first and only approvals coming in 2014: oral pirfenidone (Esbriet®) and oral nintedanib (Ofev®). Both medicines, while effective in slowing disease progression are associated with significant adverse effects that limit dosing and their full potential for efficacy. While these medicines are an important first step to treat IPF, a substantial unmet need remains for therapies with improved safety profiles and better efficacy as either stand-alone or add-on combination therapies in both IPF and other fibrotic lung diseases. CLAD is a common form of graft failure after lung transplant, leading to progressive loss of lung function resulting in re-transplant or death. CLAD occurs despite treatment with maximum systemic doses of multiple anti-rejection drugs and affects the small airways and lung tissue. There has been promising early data treating CLAD with oral pirfenidone, however, the full potential for effective treatment is limited by severe systemic adverse effects associated with oral dosing. The Inhaled Advantage Although pirfenidone has shown promise to slow IPF disease progression, it is a low potency drug requiring a very large oral dose to achieve efficacious lung levels. Unfortunately, oral delivery results in blood levels which cause substantial adverse effects and limit the delivered lung dose. In a Phase I single dose study of AP01, we have demonstrated the potential of aerosolized pirfenidone to improve both efficacy and safety. Inhalation of a dose of AP01 equivalent to 1/16 of the licensed oral dose delivered 35-fold higher peak lung levels of pirfenidone with minimal adverse effects. (c)2011-2020 by Massinvestor, Inc. For contact info, please check out our about page.