P4 ARDS

Project
P4 ARDS
Indication
Acute Respiratory Distress Syndrome
Research
Preclinical
Phase I
Phase II
Phase III

Lipigon's fourth project focuses on the treatment of Acute Respiratory Distress Syndrome (ARDS), a condition not directly related to lipid disorders. This project was initiated due to the synergies identified in conjunction with the Lipisense® project.

Indication

ARDS är ett livshotande tillstånd som är förknippat med förlust av lungfunktion, vilket ger upphov till ökad ytspänning och leder till kollaps av luftvägarna. Det finns en rad olika orsaker till ARDS, inklusive lunginflammation, sepsis och covid-19-viruset.

ARDS är en indikation med uttalat mycket höga medicinska behov på grund av den höga dödligheten och att tillståndet kräver lång intensivvård. Behandlingsalternativen, utöver respirator, är begränsade för ARDS.

Market

ARDS affects approximately 500,000 patients annually in the USA, Europe, and Japan. Sadly, around 40 percent of ARDS patients do not survive. There is currently no approved drug therapy for ARDS patients.

According to a WHO (World Health Organization) analysis, ARDS ranks as the primary cause of death among COVID-19 patients.

The company's assessment is that the ARDS project represents a market opportunity worth several billion USD.

Market

Mechanism of Action

Research has revealed that ANGPTL4 levels are elevated in ARDS patients, and these levels correspond to the severity and mortality of the disease. Remarkably, this is the same target protein that Lipigon is addressing in the Lipisense® project, using a similar type of RNA medicine with anticipated efficacy.

ANGPTL4 is a multifunctional protein. On one hand, it regulates blood lipid levels (a key aspect of the Lipisense® project), and on the other, it influences vascular function. This latter role connects ANGPTL4 to acute lung injuries like ARDS, which can result from viral or bacterial infections.

ARDS is a life-threatening condition that can emerge during lung infections, causing the leakage of fluid into the tiniest air sacs in the lungs (alveoli), leading to acute respiratory distress. ANGPTL4 has been demonstrated in numerous studies to modulate vascular permeability. Inhibiting this protein can enhance survival rates. Importantly, this mechanism isn't just relevant to the current COVID-19 situation but also applies to seasonal influenza, other viral illnesses, and bacterial infections.

Technology

Lipigon currently possesses a range of existing compounds to consider for Project 4 (P4). The choice will be guided by these compounds’ suitability for inhalation and their ability to be absorbed effectively in lung tissue.

Partnerships

Since September 2020, Lipigon has been engaged in a collaborative partnership with researchers from The Academic Respiratory Initiative for Pulmonary Health at Nanyang Technological University in Singapore and the Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences in China.

Nanyang Technological University in Singapore has published several studies underscoring the pivotal role of ANGPTL4 in lung injuries. Notably, this protein ranked among the most significantly upregulated genes during historical events such as the 1928 Spanish flu and the 2009 swine flu.

Within the framework of this collaboration, Lipigon's drug project will undergo testing in well-established models for both bacterial and virulent lung injuries, including those associated with SARS-CoV-2.

Looking ahead, there is potential for Lipigon to explore collaborations with companies specializing in respiratory health.

Project Status Update

The substances being assessed by Lipigon's collaborative partner are sourced from the Lipisense® project, having already undergone testing to confirm their safety and tolerability. Following promising outcomes in preclinical studies, the next phase involves exploring the administration method, mechanisms of action, and any potential side effects.

In cases of evident efficacy, the company will further evaluate the prospects for ongoing development. Concurrently, preparations will be made for the drug's administration. If you wish to delve deeper into the project's current status, you can read an interview with Masoumeh Matomedi, the project leader, where she provides valuable insights into the project's progression.

 

* Source: Syed Shahzad Hasan et al. Mortality in COVID-19 patients with acute respiratory distress syndrome and corticosteroids use: a systematic review and meta-analysis, Expert Rev Respir Med. 2020: 1–15.