Orphan drug designation granted to Octreolin for oral treatment of acromegaly

Chiasma, Inc. was granted orphan drug designation by the FDA for Octreolin, for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone. Chiasma has successfully completed a Phase 1 study evaluating the safety and pharmacokinetics (PK) of Octreolin, which demonstrated a PK profile similar to that of subcutaneously injected octreotide acetate. Chiasma intends to initiate a pivotal (Phase 3) trial by the end of the year for Octreolin in acromegaly.

Octreolin is an oral form of octreotide acetate that uses Chiasma's Transient Permeability Enhancer (TPE) technology for the oral treatment of acromegaly. The TPE system allows its drug cargo to cross mucosal epithelia in the small intestine by inducing a temporary opening of the Tight Junctions that seal and regulate passage between cells (the paracellular route). The drug reaches the bloodstream effectively in its native active form.

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