Chiasma Completes Enrollment of MPOWERED(TM) Phase 3 Clinical Trial of Octreotide Capsules in Patients with Acromegaly
July 25 2018 - 3:05PM
Chiasma Anticipates Trial Completion in Q4 2019
and Release of Top-line MPOWERED Data by Early 2020
Chiasma, Inc. (Nasdaq:CHMA), a clinical-stage biopharmaceutical
company focused on improving the lives of patients with rare and
serious chronic diseases, today announced it has successfully
enrolled 135 acromegaly patients into the six-month run-in phase of
its international Phase 3 clinical trial referred to as MPOWERED
(Maintenance of Acromegaly Patients with Octreotide Capsules
Compared With Injections – Evaluation of REsponse Durability). This
Phase 3 trial is being conducted to potentially obtain regulatory
approval in the European Union of its octreotide capsules product
candidate, conditionally trade-named MYCAPSSA®, for the maintenance
therapy of adult patients with acromegaly.
“We are making significant progress as we seek
to advance octreotide capsules as a maintenance treatment for adult
patients with acromegaly. If approved, octreotide capsules will
provide these patients with an oral alternative to the current
standard of care, injectable somatostatin analogs,” said Mark
Fitzpatrick, president and CEO of Chiasma. “Completing enrollment
of 135 patients into the run-in phase of the MPOWERED Phase 3 trial
provides us with confidence that a minimum of 80 MYCAPSSA
responders will be randomized to the nine-month controlled phase
and that we will ultimately have sufficient data to enable us to
seek regulatory approval in the European Union. We now expect to
complete the MPOWERED trial in Q4 2019 and release top-line data
from this trial by early 2020. This timing is consistent with the
plans that we have previously announced.”
The Company also recently announced that it has
achieved 50% patients randomized in its CHIASMA OPTIMAL Phase 3
trial, which is being conducted in accordance with a Special
Protocol Assessment previously agreed to with the FDA. This
enrollment milestone is an important step toward our goal of
submitting a New Drug Application with the FDA.
Octreotide capsules are an investigational new
oral drug proposed for the maintenance therapy of adult patients
with acromegaly. Acromegaly is most commonly caused by a benign
tumor of the pituitary gland that produces excess growth hormone
(GH), ultimately leading to significant health problems and early
death if untreated. GH regulates multiple metabolic processes and
stimulates the production of insulin-like growth factor 1 (IGF-1)
in the liver, which stimulates the growth of bones and other
tissues. If approved, octreotide capsules would be the first oral
somatostatin analog treatment option available for acromegaly
patients, where the current standard of care is somatostatin analog
injections.
MPOWERED™ Phase 3
Trial
Chiasma is conducting an international Phase 3
clinical trial under a protocol accepted by the European Medicines
Agency (EMA) for the Company’s octreotide capsules product
candidate for the maintenance therapy of adult patients with
acromegaly. The trial, referred to as MPOWERED, is a global,
randomized, open-label and active-controlled, 15-month trial.
Chiasma has enrolled 135 adult acromegaly patients into the trial,
of which it expects to randomize at least 80 patients who are
responders to octreotide capsules following a six-month run-in to
either octreotide capsules or injectable somatostatin receptor
ligands (octreotide or lanreotide), and then followed for an
additional nine months. The trial was initiated in March 2016 and
is designed to evaluate the proportion of patients who maintain
their biochemical response to octreotide capsules and
patient-reported outcomes in patients treated with octreotide
capsules, compared to patients treated with standard of care
injectable somatostatin receptor ligands. Chiasma anticipates the
trial to be completed in Q4 2019 and expects to release top-line
data from this Phase 3 clinical trial by early 2020.
About Chiasma
Chiasma is focused on improving the lives of
patients who face challenges associated with their existing
treatments for rare and serious chronic diseases. Employing its
Transient Permeability Enhancer (TPE®) technology platform, Chiasma
seeks to develop oral medications that are currently available only
as injections. In September 2017, the Company initiated CHIASMA
OPTIMAL, its third Phase 3 clinical trial for its octreotide
capsules product candidate, conditionally trade-named MYCAPSSA®,
for the maintenance therapy of adult patients with acromegaly in
whom prior treatment with somatostatin analogs has been shown to be
effective and tolerated following agreement with the FDA on the
design of the trial. Chiasma is headquartered in Waltham, MA with a
wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are
registered trademarks of Chiasma. For more information, please
visit the Company’s website at www.chiasma.com.
Forward-Looking Statements
This release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements
regarding the Company’s development of octreotide capsules,
conditionally named MYCAPSSA, for the treatment of acromegaly, the
Company’s efforts to potentially obtain regulatory approval in the
European Union by conducting the Phase 3 MPOWERED clinical trial,
the timing of receipt and announcement of top-line and other
clinical data and submission of regulatory filings, including the
Company’s ability to randomize at least 80 patients who are
responders to octreotide capsules in the MPOWERED trial, its
ability to complete the trial in Q4 2019 and to release top-line
data from the MPOWERED trial by early 2020. Any forward-looking
statements in this press release are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. For a discussion of these and other
risks and uncertainties, and other important factors, any of which
could cause our actual results to differ from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in Chiasma’s Quarterly Report on Form 10-Q for the quarter
ended March 31, 2018 filed with the Securities and Exchange
Commission (SEC) on May 10, 2018, and in subsequent filings with
the Securities and Exchange Commission. All information in this
press release is as of the date of the release, and Chiasma
undertakes no duty to update this information unless required by
law.
Contact:
Andrew BlazierSharon Merrill Associates(617)
542-5300chma@investorrelations.com
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