Presentation of “SPI2” Phase III Results at the EAN Virtual Congress 2020
Paris, France, May 20, 2020
MedDay Pharmaceuticals announced today that results from the pivotal Phase III study “SPI2” evaluating its investigational product MD1003 will be presented at the upcoming Virtual Congress 2020 of the European Academy of Neurology. Due to the impact of COVID-19, the presentation will be webcast on May 24, 2020 from 18:00 – 18:10 EST and held by the primary investigator of the study, Dr. Bruce Cree, Clinical Research Director at the UCSF Multiple Sclerosis Center.
For more information and access to the webcast, please visit the EAN congress page: www.eanvirtualcongress.org
MedDay’s lead candidate, MD1003, is a patented oral formulation of high dose Pharmaceutical grade Biotin (hdPB). MedDay has developed the program into and through clinical trials and has concluded two Phase III studies in progressive forms of Multiple Sclerosis. The first pivotal study MS-SPI had met its primary endpoint. As reported in March 2020, the second confirmatory Phase III study “SPI2” did not meet its primary or secondary endpoints. There were no treatment emergent safety signals in either of the studies.
MedDay was founded on the premise that neurodegenerative disorders can be treated by targeting key neurometabolic pathways.
For more information, please visit: www.medday-pharma.com
MD1003 is an investigational neurometabolic modulator[1-5] designed to target both neurodegenerative and demyelination processes through its non-immunological mechanism. As a coenzyme involved in cellular metabolism, MD1003, a high-dose Pharmaceutical-grade Biotin, has the potential to (i) enhance Krebs cycle activation to support increased energy demands of demyelinated axons and (ii) promote ensheathment through enhanced oligodendrocytes energetics. Preclinical studies support MD1003’s potential to counteract axonal energy deficiency and enhance oligodendrocytes ensheathment[6-8].
High-dose Pharmaceutical-grade Biotin (hdPB), MD1003, is an investigational product that has not been approved by regulatory authorities in any country at this stage (including the USA and Europe).
The information presented here is not intended as guidance to healthcare professionals.
MD1003® and hdPB® are registered trademarks of MedDay Pharmaceuticals.
Chief Executive Officer
Tel: +33 1 84 20 89 69