Date: 2015-03-05
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 97th Endocrine Society (ENDO) Annual Meeting in San Diego
Company: Chiasma (USA - MA)
Product: octreotide capsules
Action
mechanism: peptide. Octreotide capsules are an investigational oral form of the peptide octreotide, a somatostatin analog that is currently available only by injection. Octreotide capsules uses a proprietary technology developed by Chiasma Inc., called Transient Permeability Enhancer (TPE®) that facilitates gastrointestinal absorption of unmodified drug into the bloodstream.
Disease: acromegaly
Therapeutic area: Hormonal diseases - Rare diseases - Endocrine diseases
Country:
Trial details:
Latest
news: * On March 5, 2015, Chiasma, Inc., a U.S. privately–held biopharma company developing octreotide capsules for the orphan condition acromegaly, announced two new studies presented at the 97th Endocrine Society (ENDO) Annual Meeting in San Diego, Calif. The studies provide additional data from Chiasma’s Phase III trial and new findings on the patient burden of current injection therapies. The following data were presented: Determinants of Oral Octreotide Capsule Efficacy in Acromegaly (Abstract #21142; Oral Session Number: OR09-3): In a multicenter Phase III trial, 151 patients previously managed on injectable somatostatin analogs were switched to the company’s investigational octreotide capsules, an oral form of the peptide octreotide, a somatostatin analog, for up to 13 months. The descriptive analysis studied the relationship between baseline disease activity and the efficacy of octreotide capsules for up to 13 months (study duration). The correlation between prior injection dose and oral octreotide dose was also studied. Results showed: Baseline responses to injectable somatostatin analogs can predict response to oral octreotide. Response rates on octreotide capsules were 76% for patients completely controlled on injections, 44% for patients partially controlled on injections and 24% for patients uncontrolled on injections. Previous injectable dose also predicted response; 71% of patients previously treated with mid (or low) doses of injectable somatostatin analogs responded to octreotide capsules; a 49% response rate was observed for patients previously treated with high doses. Degree of response was reliably determined within 12 weeks of initiating octreotide capsules and was sustained through the treatment period (up to 13 months) in 85% of patients. Patient Reported Outcomes (PRO) Survey in Acromegaly Patients Treated with Parenteral Somatostatin Analogs (Abstract #19974; Poster Preview Number: PP09-4) Patients expressed a desire for potential future treatment modifications that offer major improvements over current care, including avoiding injections (44%) and better symptom control (41%). Based on Phase III results recently published online by the Journal of Clinical Endocrinology & Metabolism, Chiasma intends to submit a New Drug Application to the FDA in 2015.
A multicenter PRO study of 195 patients across nine endocrinology centers assessed for the first time the impact of chronic injections on the well-being of people with acromegaly. In this observational study, research nurses administered a questionnaire to patients treated with injectable somatostatin analogs. The survey was fielded among patients diagnosed with acromegaly and managed on somatostatin analogs administered parenterally by intramuscular or deep subcutaneous injections. Of the patients surveyed, 57% received octreotide and 43% received lanreotide, with results showing the injection burden was similar between the two medications. Results showed: 70% of patients reported acromegaly symptoms/signs, with 52% reporting that symptoms became worse toward the end of the dosing interval. 70% of patients experienced pain during or after injection, while 36% experienced pain even days later. The most frequently reported injection–related symptoms were hardness at injection site (48%), nodules (38%), swelling (28%), bruising (16%) and inflammation (7%). 36% of patients felt a loss of independence due to chronic injections. 16% of patients regularly miss work for injections (averaging 11 days per year). 44% of patients experienced problems with the preparations and administration of the injections.
