NEW YORK and JERUSALEM, June 14 /PRNewswire/ -- Chiasma, Inc., a privately held biopharma company, announced that it has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of its proprietary product Octreolin, which contains the active ingredient octreotide actetate and is administered orally. Octreolin demonstrated a PK profile similar to that of subcutaneously injected octreotide acetate. In addition, no serious adverse safety events were reported for Octreolin.
The Company also announced that it was advancing towards its goal of beginning a pivotal trial by the end of the year for Octreolin in acromegaly, a hormonal disorder that results from an excess of growth hormone (GH).
Chiasma has submitted an Orphan Drug application to the US FDA for acromegaly and will submit an application for Orphan Medicinal Product Designation to the European Agency for the Evaluation of Medicinal Products (EMEA) shortly. The Company intends to file an NDA using the 505(b)(2) regulatory pathway in the US and its EMEA equivalent, the Hybrid Application, in Europe.
Information on the Octreolin Trial
The Phase I trial was conducted in 12 healthy volunteers with a cross-over design in which subjects were each administered three single oral doses of Octreolin and a single subcutaneous injection of octreotide acetate as the reference drug (Sandostatin®). The primary objectives of the trial were to evaluate the safety, tolerability and PK of the three oral doses of Octreolin in comparison to the subcutaneous injection of octreotide acetate. Key findings included:
|SOURCE Chiasma, Inc.|
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