2020年4月28日

Avalyn製藥公司,生物製藥公司專注於發展改進治療危及生命的肺部疾病,今天宣布完成係列B融資3550萬美元。圓是由西北銀行合資企業夥伴一起參與新投資者關鍵bioVenture夥伴,和現有投資者f '資本,新生控股/ S, RiverVest Venture Partners, TPG生物技術。並發與融資,風險投資家羅伯特•Mittendorff醫學博士加入董事會。Avalyn剛剛完成注冊在霧化劑治療方案的臨床研究pirfenidone (AP01)患者的特發性肺纖維化(IPF)。所得係列B擴大公司的管道,將支持II / III期臨床試驗的啟動AP01慢性肺部的同種異體移植物功能障礙(複合),最常見的移植失敗這發生在超過50%的肺移植受者移植後的5年內,導致re-transplant或死亡。此外,基金將支持一個階段我研究AP02,霧化nintedanib,程序後進入臨床開發成功的臨床前研究在兩肺損傷模型。“申論係統性藥物靶向吸入肺交付已經成功地提高了療效和降低係統性皮質類固醇的副作用和在哮喘和慢性阻塞性肺病、支氣管擴張劑和囊性纖維化的抗生素,“a·布魯斯·蒙哥馬利博士說Avalyn製藥公司的首席執行官。“盡管2014年批準的兩個口頭antifibrotic療法,IPF和其他肺纖維化疾病與大量的未滿足的需求仍然是致命的疾病。我們希望完成改進的耐受性和療效與霧化pirfenidone nintedanib。我們很高興通過安全概要文件我們已經看到霧化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.