- Studies show acromegaly patients face significant burdens with available treatment options
NEWTON, Massachusetts and JERUSALEM, May 11, 2015 /PRNewswire/ --Chiasma, Inc., a U.S. privately held biopharma company developing octreotide capsules for the orphan condition acromegaly, today announced that two abstracts evaluating patients with acromegaly will be presented at the 17th European Congress of Endocrinology (ECE), being held in Dublin, Ireland, from May 16-20, 2015.
"The data presented at this meeting add to the growing body of evidence suggesting a new treatment option is needed for people with acromegaly," said Mark Leuchtenberger, chief executive officer of Chiasma. "I've had a chance to hear firsthand about the difficulties patients face with monthly injections, including pain and swelling. Many believe an oral alternative, if approved, to chronic injections could make a positive difference in their lives."
Octreotide capsules are in clinical development for the treatment of acromegaly, a condition for which the current standard treatment is lifelong injections. 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 U.S. Food and Drug Administration (FDA) in mid-2015. If approved, octreotide capsules will be the first and only oral somatostatin analog approved for acromegaly.
ePosters: Pituitary Basic and Neuroendocrinology
EP-710: "Patient Reported Outcomes Comparing Octreotide Capsules to Somatostatin Analog Injections – Results from a Multicenter, Baseline Controlled, Phase 3 Study in Acromegaly" Authors: Asi Haviv, Gary Patou, Susan Mathias
EP-711: "Parenteral Somatostatin Analogs: a Focus on Injection Site Adverse Reactions" Authors: Asi Haviv, William Kramer, Gary Patou
A full list of sessions at ECE relating to acromegaly is available on the ECE website.
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 associated health conditions include diabetes, hypertension, cardiac and cerebrovascular disease, and respiratory disorders.
Current treatment options include surgery to remove the 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 National Organization for Rare Disorders, acromegaly occurs in approximately 60 people per million 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.
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.
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.