Marvel Biosciences (MRVL.V), a Canadian life sciences company focused on the discovery and development of a synthetic derivative compound of know proven drugs, announced today that its wholly owned subsidiary, Marvel Biotechnology, had successfully completed a large-scale engineering run of its novel sold amorphous dispersion (SAD) formulation of MB-204 by Xhejiang Ausun Pharmaceutical.
The engineering run material will be used to support the ongoing toxicology studies of MB-204 being conducted by Pharmaron. The run itself is a key step forward to manufacturing Marvel’s lead product at a large scale for FDA Phase 1 human trials.
Marvel previously reported a highly significant increase in drug exposures in pre-clinical testing using the SAD formulation. This formulation involves coating MB-204 in a special FDA approved sugar-like polymer. This novel formulation could potentially reduce the amount of drug needed for human dosing, thereby improving the financial picture for Marvel.
Rod Matheson, CEO of Marvel, commented, “We are very pleased with our manufacturing partner Ausun for achieving another manufacturing milestone. The company is advancing effectively to the clinic, and we look forward to updating the market with news on our toxicology studies shortly.”
MB-204 is a fluorinated derivative of the U.S. FDA approved adenosine, A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine and caffeine consumption has been associated with a reduced risk for developing Parkinson’s disease, Alzheimer’s disease and improving concentration.
Marvel intends to complete Phase 1 / 2 clinical trials of MB-204 including placebo and efficacy endpoints by the end of Q1 2023.
The life science company is currently focused on developing MB-204 for three different targets including neurological diseases, non-alcoholic steatohepatitis and cancer.
The global market for the treatment of depression and Alzheimer’s disease is estimated at $30.0 billion USD.
According to the corporate presentation, up to 40% of SSRI users report apathy and loss of motivation. MB-204 may provide the motivation to return these individuals to a healthier quality of life.
The global market for non-alcoholic Steatohepatitis (Fatty liver disease) is estimated at $20.0 billion.
Marvel’s second program involves the re-development of psilocybin for the treatment of depression and addiction.
The global biotechnology market size was estimated at $1.02 trillion in 2021 and expected to grow to $1.37 trillion in 2030 at a CAGR of 13.9%.
The company reported $643,320 CAD in cash as of April 30, 2022, with a net and comprehensive loss of $392,277.
Currently Marvel trades for $0.10 per share for a market cap of $3.28 million.
