MD1003

About this program

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. MD1003 is well tolerated. Except the well-known risk of interference with laboratory results leading to potential misdiagnosis/erroneus treatment, no new safety signals have emerged from clinical trials.

All development have been stopped.

For more information on MD1003’s trials, visit https://clinicaltrials.gov.

 

About MD1003®

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].

REFERENCES

[1] Tong L. Structure and function of biotin-dependent carboxylases. Cellular and Molecular Life Sciences. 2013; 70:863-891.

[2] Murin R., et al. Immunocytochemical localization of 3-methylcrotonyl-CoA carboxylase in cultured ependymal, microglial and oligodendroglial cells. Journal of Neurochemistry. 2016; 97:1393-1402.

[3] Ballhausen D., et al. Evidence for catabolic pathway of propionate metabolism in CNS: expression pattern of methylmalonyl-CoA mutase and propionyl-CoA Carboxylase alpha-subunit in developing and adult rat brain. Neuoscience. 2009; 164:578-587.

[4] Chakraborty G., et al. Fatty acid synthesizing enzymes intrinsic to myelin. Brain Res Mol Brain Res. 2003; 112(1-2): 46-52.

[5] Mock D. M. (2010). Biotin. Encyclopedia of Dietary Supplements. P. M. Coates, J. M. Betz, M. R. Blackman et al., Informa UK Ltd.: 43-51.

[6] AAN 2019, Warrington AE., et al. – High Dose Pharmaceutical Grade Biotin (MD1003), protects axons in a mouse model of chronic spinal cord demyelination.