WALTHAM, Mass., March 31, 2016 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a late-stage biopharmaceutical company developing Mycapssa™ (octreotide) capsules, an investigational new oral drug for the maintenance therapy of adult patients with the orphan disease acromegaly, today announced that data regarding Mycapssa will be presented in an oral presentation and in a poster session at ENDO 2016: The Endocrine Society’s 98th Annual Meeting & Expo, which is being held in Boston, MA from April 1-4, 2016 at the Boston Convention and Exhibition Center (BCEC).
“ENDO is the largest and most well-attended event in the field of endocrinology, providing us with a tremendous opportunity to educate the scientific community about Chiasma and its unique Transient Permeability Enhancer (TPE®) technology platform,” said Gary Patou, Chiasma’s head of clinical. “Chiasma will have a strong medical and scientific presence at the event, and we are pleased that our investigational new drug, which employs TPE, will be the focus of presentations by some of the world’s leading endocrinology experts.”
Chiasma will have a medical education booth (#1034) at the conference, and octreotide capsules will be debated and discussed as part of an independent Continuing Medical Education (CME) event organized by ENDO. In addition, Chiasma will host an exhibit booth and sponsor an educational event at the Endocrine Nurses Society (ENS) Annual Symposium, which is being held in conjunction with ENDO on Sunday, April 3rd.
Select ENDO Presentations:
Oral Octreotide Capsules Improve Acromegaly-Related Symptoms in Patients Transitioned from Injectable Octreotide or Lanreotide
Oral presentation by Nienke R. Biermasz, MD, PhD of Leiden University Medical Center in Leiden, Netherlands
Saturday, April 2 in Room 107 at BCEC (#OR18-2)
Session Time: 11:45 a.m. – 1:15 p.m.
Novel Approach to Dose Optimization of Oral Octreotide in Patients with Acromegaly Transitioned from Injectable Somatostatin Analogs
Poster presentation by Maria Fleseriu, MD, FACE, professor and director of NW Pituitary Center, Oregon Health & Science University in Portland, Oregon
Sunday, April 3 in Hall AB1 at BCEC (LBSun-34)
Session Time: 1:15 p.m. – 3:15 p.m.
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. There are an estimated 69,000 individuals with acromegaly worldwide. In 13 studies of acromegaly prevalence since 1980, an average of approximately 75 cases per million was determined, suggesting roughly 24,000 individuals with acromegaly in the United States. 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.
Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease.
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, which are the current standard of care.
Mycapssa is an investigational new oral drug proposed for the maintenance therapy of adult patients with acromegaly. If approved, octreotide capsules would be the first oral somatostatin analog approved for acromegaly. Chiasma submitted an NDA on June 15, 2015 for this product candidate. The FDA accepted the NDA for filing, and the PDUFA date is April 15, 2016. The PDUFA date is the target date for the FDA to complete its review of the NDA. Octreotide capsules have been granted orphan designation in the United States and the European Union for the potential treatment of acromegaly.
Octreotide capsules are an investigational drug that has not been approved for use in any jurisdiction. The trade name Mycapssa has been conditionally accepted by the FDA and EMA as the proprietary name for Chiasma’s octreotide capsules product candidate.
Chiasma’s proprietary Transient Permeability Enhancer (TPE) technology platform uniquely enables the development of oral forms of medications that are currently only available as injections. TPE protects drug molecules from digestive enzymes and triggers the temporary expansion of tight junctions between cells of the intestinal epithelium, which is a naturally occurring process. As a result, drug molecules are allowed to pass into the blood stream while larger structures such as toxins, bacteria and viruses are excluded.
TPE’s ability to enhance oral bioavailability is the result of a unique combination of excipients that create a lipophilic suspension of solid hydrophilic particles in a hydrophobic medium. In all chronic toxicology and clinical trials, there have been no TPE-related safety signals or formulation-related adverse events. The only adverse events that have been detected were associated with side effects of the study drug itself and the underlying disease. TPE is an investigational platform that has not been approved for use in any jurisdiction.
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 Mycapssa™ (octreotide) capsules, an investigational new drug under FDA review for the orphan condition acromegaly, developed with Chiasma’s Transient Permeability Enhancer (TPE®) technology to facilitate gastrointestinal absorption of unmodified drug into the bloodstream safely. Mycapssa is a proposed tradename, and this investigational new drug has not been approved for use in any jurisdiction. Using TPE technology, 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. TPE technology is potentially well suited for drugs with chronic indications, where frequent dosing is required and the need for an oral alternative is greatest. Chiasma is a Delaware corporation with a wholly owned Israeli subsidiary. Mycapssa™ and TPE® are trademarks of Chiasma.
Additional information can be found at www.ChiasmaPharma.com.
Readers should note that Chiasma communicates with investors and the public using its website (www.ChiasmaPharma.com) and its investor relations website (http://ir.chiasmapharma.com), including but not limited to company disclosures; investor presentations and FAQs; Securities and Exchange Commission filings; press releases; public conference calls and webcasts. The information that the company posts on these websites could be deemed to be material information. As a result, Chiasma encourages investors, the media, and others interested to review the information that is posted there on a regular basis. The contents of the company’s website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.