Work on growth differentiation factor 11 involved parabiosis techniques in which circulatory systems of young and old mice were combined to allow blood flow between the animals that suggested injecting GDF11 into old animals regenerated cardiac, brain, and muscle tissue, and was named Science’s breakthrough of the year in 2014. Elevian holds exclusive rights under a portfolio of patent families licensed from Harvard and research partners claiming methods and compositions for modulation of GDF11 to treat disease and conditions related to aging.
The hypothesis was controversial when another group from NIBR tried to reproduce the findings but failed and concluded the protein increased age and inhibits skeletal muscle regeneration. Shots have been traded between the two since then over integrity of their respective studies and research methods. Elevian has said data soon to be released will firm up and elucidate evidence of GDF11 playing key roles in anti-aging with its therapeutic strategy of modulating upwards active GDF11 levels that can be achieved by exogenous administration of recombinant proteins, and by targeting natural regulation mechanisms of the protein.
Elevian is pursuing preclinical program in cardiovascular disease, sarcopenia, and type 2 diabetes, they expect to complete preclinical efficacy and safety studies in multiple therapeutic indications and initiate their first human clinical study in 2-3 years, aiming to achieve successful human proof of concept relatively quickly in each of these indications.
The cardiovascular program is supported by human clinical data from the laboratory of Peter Ganz at UCSF demonstrating subject with low levels of a measure of GDF11 have increased mortality rates.
Receiving approval for the lead indications requires expensive large scale and time consuming studies, additional indications are being considered that may provide faster regulatory paths, the company is pursuing additional funding to take two other product candidates through the IND application stage.
The new company does have an impressive slogan: “What if aging didn’t have to suck? Reimagine Aging with Elevian”…. Indeed, just imagine the possibilities.
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https://www.fiercebiotech.com/biotech/elevian-set-up-to-pursue-disputed-approach-to-aging-diseases
