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 needs at a reduced development risk.
Supported by exploratory cough data in man Melius Pharma is developing ME-015 (suplatast tosilate) as a first in class, oral treatment for chronic cough in terminally ill idiopathic pulmonary fibrosis (IPF) patients.
ME-015 is a new chemical entity in all geographies outside Japan where it has proven very safe during 25 years use in real life.
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Meet The Team
Passion and expertise combined to drive excellence
Our vision is to become a preferred leading biopharmaceutical company for development of drug candidates with proven track records of safety and tolerability, thus significantly de-risking clinical development and increasing attractiveness for partnering and licensing 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 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 2a 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 refractory 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 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 life science.
August 2021
Melius Pharma is founded
November 2022
Initiation of Phase 2a IPF cough study
February 2025
Topline results for Phase 2a IPF cough
May 2022
Linc och Fåhraeus Startup and Growth AB invests in Melius Pharma
July 2023
First patients included in Phase 2a IPF cough
Our approach
To develop treatments with proven real-life safety in high value indications that benefit all stakeholders
Payor
Clear value proposition.
No risk of using budget on management of side effects.
Physicians
Opportunity to prescribe safe medicines in areas with high unmet needs.
Regulator
Benefit/risk ratio above industry standards.
Low risk of managing safety issues.
Licensors
Access to low-risk phase IIb/III development assets. In-licencing terms that are attractive from risk adjusted perspective.
Patients
Access to safe medicines based on real world safety data and clinically proven efficacy.