Myogem Health Company S.L. (www.myogemhealth.com) is a B2C life sciences company focused in R&D of nutritional products to manage neuromuscular rare and prevalent diseases. Through the project "New food for special medical purposes for the nutritional management of Myotonic Dystrophy type 1 (DM1)", funded by EU under SME Instrument Phase 1 in H2020 grant agreement No 87615, MYOGEM aimed to upgrade its product MYODM “food supplement” (a unique combination of caffeine and theobromine that restored atrophy, increased muscle area, recovered heart functions; increased mean survival and life expectancy in in vivo DM1 animal models) to MYODM-FSMP “food for special medical purposes”. FSMP are foods intended for the dietary management of individuals who suffer from certain diseases, and involve the supervision of the medical community. For certain rare diseases, this approach may provide a unique affordable option, since they are niche markets. The feasibility studies have included technical, economic and regulatory assessment for properly placing MYODM-FSMP product in the market.
DM1, or Steinert's disease, is a complex neuromuscular disease of genetic origin, without any cure and highly limiting of the quality of life. DM1 is a multisystemic autosomal dominant disorder, clinically characterized by progressive muscle atrophy and weakness, cardiomyopathy, insulin resistance and cataracts, among others. Overall, DM1 patients have a very limited quality of life (QoL), wherein QoL is a multidimensional concept that encompasses physical, psychological and social factors, whose impact on each patient depends on individual and social conditions
The main hypothesis guiding the present project is that the controlled and dosaged administration of the formulated composition containing caffeine and theobromine marketed as MYODM could be useful for the nutritional management of DM1 patients, potentially contributing to the reduction of daytime sleepiness and to the improvement of Health-Related Quality of Life of these patients.
The main goal of the present project was to evaluate the effect of MYODM on DM1’s patients quality of life and excessive daytime sleepiness through the pilot interventional clinical trial “Research project to evaluate the effect of the MYODM food supplement on quality of life, fatigue and hypersomnia in patients with Myotonic Dystrophy type 1” (clinicaltrials.gov nr NCT04634682), sponsored by MYOGEM, run at the Neurology Service of the Donostia University Hospital, led by Dr. Roberto Fernández Torrón and assisted by the CRO MIAKER Developments, S.L. The pilot clinical trial was conceived as a monocentric six month randomized pilot interventional clinical trial to test these hypothesis.
