Maryland Patent of the Month – August 2022

ReveraGen Biopharma, Inc., a small clinical-stage drug development company, has set their sights on developing therapeutics for Duchenne muscular dystrophy. This progressive disease typically first presents weakness in early childhood. Caused by gene mutations in the DMD gene, the patient experiences a loss of dystrophin protein in muscle from fetal life onwards. This means weakness in all forms of muscle including skeletal and heart muscles. 

Prednisone and deflazacort have been tested and proven to inhibit NFkB cell danger pathways. These pathways initiate soon after birth, helping the muscle to regenerate and compensate for the dystrophin deficiency. Unfortunately, due to overuse, these signals eventually transition to scar tissue formation, leading to weakness and muscle loss. ReveraGen’s studies on vamorolone – a glucocorticoid – attempt to better inhibit these pathways and slow the transition to fibrosis and muscle loss.

Prednisone and deflazacort are thought to be effective at preventing this transition due to their anti-inflammatory effects, a quality shared by vamorolone. However, these tend to have unwanted side effects including impacts on bone structure and function. Vamorolone, on the other hand, effectively separates these subactivities, maintaining its efficacy while avoiding the side effects. To support this research, the company has recently patented an aqueous oral pharmaceutical suspension of their vamorolone Form I, which can be used in their clinical trials. The patented formulation process addresses achieving the required stability, oxidation, and dosage.

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