SSAs bind to somatostatin receptors, inhibiting secretion of growth hormone. This activity is also associated with undesirable inhibition of other endocrine hormones (eg, insulin, glucagon) in locations outside the pituitary.
We believe that veldoreotide may offer an improved safety and efficacy profile—compared with current SSAs—because of its differentiated activation of somatostatin receptor subtypes. We have completed the screening of potential long-acting release (LAR) technologies for veldoreotide, and selected a proprietary formulation based upon PLGA microspheres for further development. PLGA is a well-known polymer, which has been widely applied in LAR formulations due to its biocompatibility, biodegradability, and favorable release kinetics.
Veldoreotide has been granted orphan drug designation by the FDA and the EMA.
In short-term Phase 1 and 2 studies in healthy volunteers and untreated patients with acromegaly, respectively, the effects of subcutaneously administered veldoreotide on stimulated or basal growth hormone and postprandial glucose and insulin secretion were compared with those of subcutaneous injections of immediate-release octreotide. The findings suggest that veldoreotide has similar ability as octreotide to suppress growth hormone but has reduced propensity to inhibit postprandial insulin.1,2
Based on the differentiated activation pattern of somatostatin receptor subtypes (“SSTs”) and the preclinical and clinical profile of immediate-release veldoreotide, we believe that modified-release veldoreotide is a next-generation somatostatin analog with potential applications in endocrine and non-endocrine conditions that are amenable to somatostatin receptor activation.
No serious adverse events were observed, and mostly mild adverse events typical for SSAs such as injection site reactions and gastrointestinal side effects were reported. There was no evidence that veldoreotide adversely affects the liver, kidneys, or other organ systems, including the cardiovascular system.
The safety and efficacy of veldoreotide for treatment of acromegaly have not been established.
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MLR-0010 V20 10/2020