Inspiring signals, IPF is expected to enter the era of inhalation therapy! ----RSN0402 Powder for I - Shenzhen Resproly Biophaemaceutical Co.,Ltd.

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Inspiring signals, IPF is expected to enter the era of inhalation therapy!----RSN0402 Powder for Inhalation developed by Resproly has successfully completed the enrollment of the first subject in the Phase I clinical trial in Australia.

2024-08-14

Inspiring signals, IPF is expected to enter the era of inhalation therapy!

----RSN0402 Powder for Inhalation developed by Resproly has successfully completed the enrollment of the first subject in the Phase I clinical trial in Australia.

重磅积极信号，IPF有望进入吸入治疗时代！

13 August 2024, Shenzhen Resproly Bio Pharmaceutical Co., Ltd. announced that its subsidiary, Zhuhai Resproly Pharmaceutical Technology Co., Ltd., which independently developed RSN0402 powder for inhalation, has successfully completed the first enrolment and administration of healthy subjects in a clinical trial conducted in Australia. The trial is a randomised, double-blind, single-centre, first-in-human Phase I study, which is the first time RSN0402 powder for inhalation has been used in humans after completion of preclinical studies. The study was designed to evaluate the tolerability, safety and pharmacokinetic profile of RSN0402 administered by oral inhalation.

What is IPF？

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive-fibrosing interstitial lung disease (ILD) of unknown origin characterized by progressive lung scarring and the histologic picture of usual interstitial pneumonia. Which is that ultimately leads to destruction of lung structure and loss of normal function, manifested by progressively worsening dyspnoea, with pulmonary function tests suggesting diffusive and ventilatory dysfunction, leading to hypoxaemia and even respiratory failure. Data show that IPF affects 3 million people worldwide, particularly in the United States, Canada and some western countries, and its prevalence is increasing exponentially almost every 10 years. The median survival of patients from diagnosis is only 3-5 years.

重磅积极信号，IPF有望进入吸入治疗时代！ “瑞思普利”自主研发的RSN0402吸入粉雾剂成功完成I期临床首例受试者入组

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial lung disease. The treatment cost of IPF mainly depends on drugs, treatment duration and hospital grade. Currently, the treatment options for IPF are limited worldwide. Nintedanib and pirfenidone are promising pharmacological options for IPF which can effectively slowdown disease progression and improve survival rate in IPF patients. The treatment cost for IPF is relatively high, for example the annual price of pirfenidone is up to $36,000 in UK, and the annual cost of each drug is more than $100,000 in US, which contributes to heavy economic burden on patients and their families, as well as the health care system. Patients and physicians need to be aware of their potential side effects and adjust treatment strategies as needed when choosing pirfenidone or nintedanib as an option for IPF. Nintedanib, although effective, is associated with significant and serious adverse effects that limit dosing, such as gastrointestinal side effects, hepatotoxicity, arterial thromboembolism, bleeding events, gastrointestinal perforation, nephrotic albuminuria, etc. In addition, the most common adverse events were diarrhoea, nausea, abdominal pain, vomiting, elevated liver enzymes, decreased appetite, headache, weight loss and hypertension. These adverse effects are assumed to be related to systematic exposure after oral dosing. According to published literature, it was reported that diarrhoea happened in 62.0% IPF patients using nintedanib, while diarrhoea led to 11.0% permanent dose reduction and 5% discontinuation in nintedanib therapy. In another study of chronic fibrosing ILDs with progressive phenotypes and a study of SScILD, diarrhoea was reported in 67% and 76% of patientsrespectively in nintedanib group.

重磅积极信号，IPF有望进入吸入治疗时代！ “瑞思普利”自主研发的RSN0402吸入粉雾剂成功完成I期临床首例受试者入组

In view of the status of IPF treatment and unmet clinical needs, Resproly, relied on its powerful EDDIP inhalation research and development platform, has successfully developed RSN0402 powder for inhalation (RSN0402) after three years. The innovative new drug can be a precise lung-targeted therapy via inhalation, a new route of administration, which significantly reduced the dose. It is expected to achieve better clinical efficacy, while significantly reducing the incidence of gastrointestinal adverse effects caused by the oral route.

It has been shown in preclinical studies that RSN0402 was safe and well tolerated and significantly reduce lung fibrosis and inflammation.

"The completion of the first subject enrolment in the Phase I clinical trial of RSN0402 is an important milestone in the development of Resproly, which is also an exciting news for IPF patients that IPF has entered the era of inhaled therapy. We will work closely with our clinical site to push forward the clinical process of the world's first new IPF inhalant powder, and lanunch the safe and effective new treatment to IPF patients as soon as possible, helping IPF patients reduce the disease burden and improve the quality of life," said Dr Yongqi Chen, Chairman and Chief Scientist of Resproly.

重磅积极信号，IPF有望进入吸入治疗时代！ “瑞思普利”自主研发的RSN0402吸入粉雾剂成功完成I期临床首例受试者入组

Shenzhen Resproly Bio Pharmaceutical Co., Ltd.(Resproly)

Resproly is a pharmaceutical company focusing on the research and development of respiratory inhalation drug delivery formulation technology and device, founded by Dr. Chen Yongqi. Chen Yongqi, the chief scientist of multinational companies, who has been deeply involved in inhalation formulation for many years, the company have approximately 10,000 square metres of R&D and GMP production facilities that meet the requirements of China, the United States and the European Union, and has received more than 300 million yuan of investment from well-known investment institutions such as Qianhai Ark, CAS Investment, Hygeia Capital and Tongchuang Weiye. The company has received investment from well-known investment institutions such as Qianhai Ark, National Science and Technology Investment, Waige Capital and Tongchuang Weiye. Based on the inhalation powder preparation, the company relies on the independently established EDDIP inhaler R&D technology platform to develop a series of complex inhalation medicines to meet the clinical needs of asthma, chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF) and other therapeutic areas. Resproly is the only innovative company in China that can independently develop and commercially produce all three types of inhalation dosage forms and devices, including single-dose capsules, multiple-dose blisters and turbuhaler and aims to become a leading company in this field.

Resproly always adheres to the concept of responsibility first, with our innovation, quality and technical services, to improve the lives and quality of existence of people suffering from respiratory diseases around the world, and to contribute to the health of mankind.

References：

1. Glassberg MK. Overview of idiopathic pulmonary fibrosis, evidence-based guidelines, and recent developments in the treatment landscape. Am J Manag Care. 2019 Jul;25(11 Suppl):S195-S203.

2. Jiang Qiuyan, Liang Qing, Gao Shaoyan, et al. Research progress of idiopathic pulmonary fibrosis treatment drugs [J]. Chinese Journal of New Drugs, 2021, 30 (14): 1274-1281.

3.Dempsey TM, Thao V, Moriarty JP, Borah BJ, Limper AH. Cost-effectiveness of the anti-fibrotics for the treatment of idiopathic pulmonary fibrosis in the United States. BMC Pulm Med. 2022 Jan 10;22(1):18.

重磅积极信号，IPF有望进入吸入治疗时代！ “瑞思普利”自主研发的RSN0402吸入粉雾剂成功完成I期临床首例受试者入组