Summary
Idiopathic Pulmonary Fibrosis (IPF) is a progressive lung disease with no curative therapies. Approved therapies for IPF have a high rate of discontinuation among patients due to adverse side-effects and present a high unmet need for effective therapies. Oxcia’s OXC-201 is a ground-breaking novel approach for treatment of IPF, based on completely new biology. OXC-201 targets profibrotic and proinflammatory cascades at an early stage on a transcriptional level, and is expected to efficiently prevent lung damage, creating a window for restorative processes to repair scar tissue. OXC-201 has demonstrated significant efficacy in halting disease progression and improved safety and tolerability in preclinical IPF models. In the TOPFIBRO project we will 1) obtain further proof of concept of OXC-201’s efficacy in improving lung function in vivo and confirm antifibrotic efficacy in patient-derived ex vivo models compared to current standard of care, 2) take OXC-201 through preclinical safety assessment studies, 3) fulfill regulatory demands, preparation of IMPD, CTA and ethical applications in order to initiate first-in-human studies, 4) perform first-in-human clinical studies to determine safety profile in healthy volunteers, 5) develop a strong business plan with regulatory, financial and clinical roadmaps to improve investor-readiness. These steps will allow us to further develop OXC-201 with the end goal of bringing it to market via a licensing deal with a large pharmaceutical company. OXC-201 has the potential to fill a large unmet need of the IPF patient community and present the first potentially curative therapy.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101113048 |
| Start date: | 01-05-2023 |
| End date: | 30-04-2026 |
| Total budget - Public funding: | 2 499 998,75 Euro - 2 499 998,00 Euro |
Cordis data
Original description
Idiopathic Pulmonary Fibrosis (IPF) is a progressive lung disease with no curative therapies. Approved therapies for IPF have a high rate of discontinuation among patients due to adverse side-effects and present a high unmet need for effective therapies. Oxcia’s OXC-201 is a ground-breaking novel approach for treatment of IPF, based on completely new biology. OXC-201 targets profibrotic and proinflammatory cascades at an early stage on a transcriptional level, and is expected to efficiently prevent lung damage, creating a window for restorative processes to repair scar tissue. OXC-201 has demonstrated significant efficacy in halting disease progression and improved safety and tolerability in preclinical IPF models. In the TOPFIBRO project we will 1) obtain further proof of concept of OXC-201’s efficacy in improving lung function in vivo and confirm antifibrotic efficacy in patient-derived ex vivo models compared to current standard of care, 2) take OXC-201 through preclinical safety assessment studies, 3) fulfill regulatory demands, preparation of IMPD, CTA and ethical applications in order to initiate first-in-human studies, 4) perform first-in-human clinical studies to determine safety profile in healthy volunteers, 5) develop a strong business plan with regulatory, financial and clinical roadmaps to improve investor-readiness. These steps will allow us to further develop OXC-201 with the end goal of bringing it to market via a licensing deal with a large pharmaceutical company. OXC-201 has the potential to fill a large unmet need of the IPF patient community and present the first potentially curative therapy.Status
SIGNEDCall topic
HORIZON-EIC-2022-TRANSITIONOPEN-01Update Date
31-07-2023
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