New treatments for chronic cough in interstitial lung diseases
About
Melius Pharma
High value indications at low development risk
Melius Pharma is a Swedish clinical stage pharmaceutical company. We develop treatments for severe diseases with high unmet clinical needs at a reduced development risk.
Supported by exploratory cough data in several indications, Melius Pharma is developing ME-015 (suplatast tosilate) as a first in class, safe and well tolerated oral treatment for chronic cough in idiopathic pulmonary fibrosis (IPF) patients.
ME-015 is a new chemical entity in all geographies outside of Japan where it has been on the market for over 25 years for different indications with a very good safety profile.
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Meet The Team
Passion and expertise combined to drive excellence
Our vision is to become a leader in development of drug candidates with proven safety and tolerability, significantly de-risking clinical development and increasing attractiveness for partnering at an early stage.
To achieve this we have assembled a team with complementary experience in strategic and operational drug development.
Melius Pharma’s experienced team sources projects with low development risk. Early input by Melius Pharma’s Pricing & Market Access experts allow for payer relevant clinical study designs thus improving the chances of our drugs being not just approvable but also reimbursable at a good price.
Click below to learn more and meet the team.
ME-015 is a new chemical entity in the US and EU
More than 25 years of real-world safety data in Japan
Melius Pharma‘s first target indication is the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF). IPF is a rare lung disease with high mortality and a large unmet clinical need where average life expectancy is only 3-5 years at diagnosis.
With 25 years of real-world safety data in Japan ME-015 is now entering Phase 2 for the treatment of IPF cough. Four investigator-initiated clinical cough trials performed in Japan suggest efficacy for reducing cough frequency and severity in non-IPF related cough, further de-risking the development.
Mechanistic evidence suggest ME-015 may reduce C-fibre hypersensitivity and neurogenic inflammation – presumed to be important drivers of persistent cough in IPF.
Milestones
Melius Pharma was founded in August 2021 with a mission to source products with lower clinical development risk than current Pharma standards and pursue development in high value indications.
In the autumn of 2021, Melius Pharma acquired the rights to its first project. Originator of the product is Taiho Pharmaceuticals, a subsidiary of Otsuka Holdings. Melius Pharma is developing the product in cough related to IPF (IPF cough) as a first indication.
In May 2022, Melius Pharma successfully raised funds in a Series A round from Linc and Fåhraeus Startup and Growth, two of Sweden’s most seasoned investment groups in the life sciences.
August 2021
Melius Pharma is founded
December 2023
Initiation of Phase 2 IPF cough study
Expected mid 2025
Topline results for Phase 2 IPF cough
May 2022
Linc AB och Fåhraeus Startup and Growth AB invest in Melius Pharma
Expected March 2024
First patient included in Phase 2 IPF cough
Our approach
To develop treatments with proven real-life safety in high value indications that benefit all stakeholders
Licensors
Access to low-risk phase 2/3 assets with well defined go to market strategy.
Regulator
Benefit/risk ratio above industry standards. Low risk for unexpected safety issues.
Payor
Clear value proposition.
Low risk of side effects and related costs.
Patients
Access to safe medicines with clinically proven efficacy.
Physicians
Opportunity to prescribe safe medicines in areas with high unmet clinical need.