Submission based on positive results from Phase 3 clinical trial
NEWTON, MA, USA and JERUSALEM, Israel I June 15, 2015 I Chiasma, Inc., a U.S. privately held biopharma company, today announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of octreotide capsules, an investigational drug for the maintenance treatment of adults with acromegaly. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
The application is supported by a multicenter Phase 3 study, which evaluated patients for biochemical and symptomatic disease control over a period of up to 13 months following treatment with octreotide capsules, comprised of a 7-month core treatment phase and an optional 6-month extension phase. Sixty-five percent of patients in the modified intent to treat (mITT) population who received octreotide capsules twice-a-day were classified as responders, as measured by circulating concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH), at the end of the 7-month core treatment period, the primary endpoint of the trial. Sixty-two percent of patients in the mITT population were classified as responders at the end of the 6-month extension phase. In the study, the severity and incidence of acromegaly symptoms improved while on octreotide capsules, compared to baseline. The Phase 3 results were published in the Journal of Clinical Endocrinology & Metabolism.
The NDA was submitted utilizing the FDA’s 505(b)(2) regulatory pathway. The 505(b)(2) pathway enables a sponsor to rely, in part, on the FDA’s prior findings of safety and efficacy for a previously approved product, or published literature, in support of the NDA.
If approved, octreotide capsules will be the first oral somatostatin analog approved for acromegaly. Octreotide capsules has been granted orphan designation in the U.S. and the EU for the treatment of acromegaly.
About Acromegaly
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet and tongue. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, cardiac and cerebrovascular disease, and respiratory disorders.
Current treatment options include surgery to remove the pituitary tumor, radiation therapy which destroys any lingering tumor cells and/or medical treatment in cases where these approaches are not possible or fully effective. Today’s medical treatments include dopamine agonists, GH antagonists and injectable somatostatin analogs, the current standard of care. Currently available somatostatin analogs require large-bore needles for injections into muscle (octreotide) or deep into the tissue underlying the skin (lanreotide).
Researchers estimate that three to four out of every million people develop acromegaly each year. According to the U.S. National Institutes of Health, acromegaly occurs in approximately 60 people per million in the U.S. Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease.
About Octreotide Capsules
Octreotide capsules are an investigational oral form of the peptide octreotide, a somatostatin analog that is currently available only by injection. Octreotide capsules use a proprietary technology developed by Chiasma, Inc., called Transient Permeability Enhancer (TPE®) that facilitates gastrointestinal absorption of unmodified drug into the bloodstream. Chiasma is independently leading the clinical and regulatory development and commercialization of octreotide capsules for the potential treatment of acromegaly and neuroendocrine tumors.
About Chiasma
Chiasma is a late-stage biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is octreotide capsules for the orphan condition acromegaly. Chiasma is evaluating additional proteins, peptides and small molecule drugs that are currently only available by injection, but could potentially be converted to oral delivery using the company’s TPE® technology. Chiasma is a Delaware corporation with a wholly owned Israeli subsidiary.
SOURCE: Chiasma
Post Views: 31
Submission based on positive results from Phase 3 clinical trial
NEWTON, MA, USA and JERUSALEM, Israel I June 15, 2015 I Chiasma, Inc., a U.S. privately held biopharma company, today announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of octreotide capsules, an investigational drug for the maintenance treatment of adults with acromegaly. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
The application is supported by a multicenter Phase 3 study, which evaluated patients for biochemical and symptomatic disease control over a period of up to 13 months following treatment with octreotide capsules, comprised of a 7-month core treatment phase and an optional 6-month extension phase. Sixty-five percent of patients in the modified intent to treat (mITT) population who received octreotide capsules twice-a-day were classified as responders, as measured by circulating concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH), at the end of the 7-month core treatment period, the primary endpoint of the trial. Sixty-two percent of patients in the mITT population were classified as responders at the end of the 6-month extension phase. In the study, the severity and incidence of acromegaly symptoms improved while on octreotide capsules, compared to baseline. The Phase 3 results were published in the Journal of Clinical Endocrinology & Metabolism.
The NDA was submitted utilizing the FDA’s 505(b)(2) regulatory pathway. The 505(b)(2) pathway enables a sponsor to rely, in part, on the FDA’s prior findings of safety and efficacy for a previously approved product, or published literature, in support of the NDA.
If approved, octreotide capsules will be the first oral somatostatin analog approved for acromegaly. Octreotide capsules has been granted orphan designation in the U.S. and the EU for the treatment of acromegaly.
About Acromegaly
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet and tongue. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, cardiac and cerebrovascular disease, and respiratory disorders.
Current treatment options include surgery to remove the pituitary tumor, radiation therapy which destroys any lingering tumor cells and/or medical treatment in cases where these approaches are not possible or fully effective. Today’s medical treatments include dopamine agonists, GH antagonists and injectable somatostatin analogs, the current standard of care. Currently available somatostatin analogs require large-bore needles for injections into muscle (octreotide) or deep into the tissue underlying the skin (lanreotide).
Researchers estimate that three to four out of every million people develop acromegaly each year. According to the U.S. National Institutes of Health, acromegaly occurs in approximately 60 people per million in the U.S. Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease.
About Octreotide Capsules
Octreotide capsules are an investigational oral form of the peptide octreotide, a somatostatin analog that is currently available only by injection. Octreotide capsules use a proprietary technology developed by Chiasma, Inc., called Transient Permeability Enhancer (TPE®) that facilitates gastrointestinal absorption of unmodified drug into the bloodstream. Chiasma is independently leading the clinical and regulatory development and commercialization of octreotide capsules for the potential treatment of acromegaly and neuroendocrine tumors.
About Chiasma
Chiasma is a late-stage biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is octreotide capsules for the orphan condition acromegaly. Chiasma is evaluating additional proteins, peptides and small molecule drugs that are currently only available by injection, but could potentially be converted to oral delivery using the company’s TPE® technology. Chiasma is a Delaware corporation with a wholly owned Israeli subsidiary.
SOURCE: Chiasma
Post Views: 31
