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
LanreotideOral presentation by Nienke R. Biermasz, MD, PhD
of Leiden University Medical Center in Leiden, NetherlandsSaturday,
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.
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. 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.
About Mycapssa™
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.
About
TPE®
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.
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 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.
Online Resources
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.
Contacts:
Media:
Cammy Duong
MacDougall Biomedical Communications
(781) 591-3443
cduong@macbiocom.com
Investors:
Jason Fredette
Chiasma, Inc.
(617) 928-5306
Jason.Fredette@ChiasmaPharma.com
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