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Chiasma's Octreolin™ (Oral Octreotide) Shown to Inhibit Growth Hormone in Healthy Subjects
Date:6/6/2011

NEW YORK and JERUSALEM, June 6, 2011 /PRNewswire/ -- Chiasma, Inc., a privately held biopharma company, presented pharmacology results from clinical studies at the 12th International Pituitary Congress showing that Octreolin, a proprietary investigational new oral formulation of octreotide, demonstrated a consistent pharmacokinetic (PK) profile similar to that of subcutaneously injected octreotide acetate. Most important, the data illustrated that Octreolin reduced growth hormone (GH) levels, a clinical endpoint that has been used for approval in other drugs for acromegaly.

Chiasma is developing Octreolin as an oral treatment for acromegaly and anticipates that a Phase 3 trial in patients will begin enrollment later in 2011.

Pharmacodynamic data presented at the Congress demonstrated that a single dose of Octreolin administered to healthy subjects significantly suppressed both basal GH secretion and Growth Hormone Releasing Hormone (GHRH)-stimulated GH secretion by about 80%. Inhibition was recorded in all 18 subjects receiving Octreolin as compared to their GH levels without Octreolin. The mean reductions in both basal and stimulated GH levels were statistically significant (P<0.001).

In addition, the presentation summarized results from three clinical studies with Octreolin. These data showed that:

  • Octreolin was absorbed after oral administration within 1 hour;
  • There was a reproducible linear dose-dependent relationship for the 3 doses studied;
  • An oral dose of Octreolin 20 mg provided similar systemic exposure to octreotide 0.1 mg given via subcutaneous (SC) injection;
  • The drug was well tolerated with no significant clinical or preclinical adverse events;
  • Side effects of Octreolin were comparable to those of injectable octreotide.

Octreolin utilizes the Company's proprietary Transient Permeability Enhancer (TPE) technology, which enables previousl
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SOURCE Chiasma, Inc.
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