Chiasma Announces First Patient Is Randomized in Phase 3 CHIASMA OPTIMAL Clinical Trial of Octreotide Capsules in Patients wi...
September 27 2017 - 4:05PM
Chiasma, Inc. (Nasdaq:CHMA), a clinical-stage biopharmaceutical
company focused on improving the lives of patients with rare and
serious chronic diseases, today provided an update on both of its
international Phase 3 clinical trials of its octreotide capsules
product candidate, conditionally trade-named Mycapssa®, for the
maintenance therapy of adult patients with acromegaly.
The company announced the randomization of the first patient in
its new Phase 3 trial referred to as “CHIASMA OPTIMAL” (Octreotide
capsules vs. Placebo Treatment In MultinationAL centers), meeting
its previous guidance that enrollment in the study would begin
during the second half of 2017.
The CHIASMA OPTIMAL study is being conducted under a Special
Protocol Assessment (SPA) with the U.S. Food and Drug
Administration (FDA)’s Division of Metabolism and Endocrinology
Products. A SPA is a process by which an applicant and the FDA
reach an agreement on the protocol design, endpoints and analysis
of a Phase 3 clinical study prior to initiation, in order to
determine if the study adequately addresses scientific and
regulatory requirements for FDA approval.
Chiasma also announced it has recently surpassed 50% patients
randomized in its international Phase 3 clinical trial, referred to
as MPOWERED (Maintenance of Acromegaly Patients with Octreotide
Capsules Compared With Injections – Evaluation of REsponse
Durability). It is a global, randomized, open-label and
active-controlled, 15-month trial.
“This is an important day for Chiasma, as we achieved two
significant milestones toward advancing octreotide capsules as a
maintenance treatment for adult acromegaly patients,” said Mark
Fitzpatrick, president and CEO of Chiasma. “Beginning enrollment in
our CHIASMA OPTIMAL Phase 3 study is an important step toward our
goal of resubmitting a New Drug Application with the FDA. We also
are encouraged by our progress in enrolling patients in MPOWERED,
Chiasma’s international Phase 3 study of octreotide capsules, to
potentially support regulatory approval in Europe. We strongly
believe in Mycapssa as a potential new treatment option for adult
patients with acromegaly, and we look forward to continuing this
important mission.”
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 may be the first oral
somatostatin analog treatment option available for acromegaly
patients, where the current standard of care is somatostatin analog
injections.
About the CHIASMA OPTIMAL Phase 3 TrialOPTIMAL is a randomized,
double-blind, placebo-controlled, nine-month clinical trial in 50
adult acromegaly patients (at least 20% of whom must be recruited
from the United States) whose disease is biochemically controlled,
based upon levels of IGF-1, a byproduct of increased GH levels
caused by acromegaly, on injectable somatostatin analogs at
baseline (average IGF-1 ≤1.0 x upper limit of normal (ULN)). The
patients must also have confirmed active acromegaly following their
last surgical intervention based upon an elevated IGF-1 at that
time of ≥1.3×ULN. The trial will be randomized on a 1:1 basis to
octreotide capsules or placebo. Patients will be dose titrated from
40mg per day to up to a maximum of 80mg per day, equaling two
capsules in the morning and two capsules in the evening. Patients
meeting predefined withdrawal criteria during the course of the
trial will revert to their original treatment of injections and
will be monitored for the remainder of the trial.
The primary endpoint of the study is the proportion of patients
who maintain their biochemical response compared to placebo at the
end of the nine-month, double-blind, placebo-controlled period as
measured using the average of the last two IGF-1 levels ≤ 1.0×ULN.
Hierarchical secondary endpoints that will be considered by the FDA
in evaluating the totality of evidence for octreotide capsules
treatment effect include: proportion of patients who maintain GH
response at week 36, compared to screening; time to loss of
response of IGF-1 > 1.0×ULN; time to loss of response of IGF-1
> 1.3×ULN; change in mean GH from screening to end of treatment;
and change in IGF-1 from baseline to end of treatment. Chiasma
anticipates the release of top-line data from this Phase 3 clinical
trial by the end of 2019.
About the MPOWERED Phase 3 TrialChiasma 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
(Maintenance of Acromegaly Patients with Octreotide Capsules
Compared With Injections – Evaluation of REsponse Durability), is a
global, randomized, open-label and active-controlled, 15-month
trial. It is expected to enroll up to 150 adult acromegaly
patients, 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. The company anticipates
the release of top-line data from this Phase 3 clinical trial in
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. The company has reached
agreement with the FDA on the design of a new Phase 3 clinical
trial for its octreotide capsules product candidate, conditionally
trade-named Mycapssa®, for the maintenance therapy of adult
patients with acromegaly. Chiasma is headquartered in the United
States with a wholly owned subsidiary in Israel. Mycapssa and TPE
are registered trademarks of Chiasma.
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 commitment to
develop new treatment options for patients with rare and serious
chronic diseases, specifically acromegaly, the company’s efforts to
potentially obtain regulatory approval in the United States by
conducting the new Phase 3 OPTIMAL clinical trial under a Special
Protocol Assessment, the company’s efforts to potentially obtain
regulatory approval in Europe by conducting the ongoing MPOWERED
Phase 3 clinical trial, the timing of receipt of top-line data and
submission of regulatory filings, including the company’s ability
to obtain top-line data from the OPTIMAL trial by the end of 2019
and the company’s ability to obtain top-line data from the MPOWERED
trial in 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. These risks
and uncertainties include, but are not limited to, risks associated
with the regulatory review and approval process generally; risks
associated with Chiasma’s Phase 3 clinical trial to support
regulatory approval of octreotide capsules in the E.U.; risks
associated with Chiasma conducting an additional randomized,
double-blind and controlled Phase 3 clinical trial to support
regulatory approval of octreotide capsules in the United States,
including risks related to the enrollment, timing and associated
expenses; risks associated with Special Protocol Assessment
agreements, including the risk that Special Protocol Assessment
agreements are not a guarantee of approval and the FDA may not
approve octreotide capsules even if the Phase 3 trial is
successful; risks associated with the ability of the company’s
suppliers to pass future regulatory inspections; risks associated
with obtaining, maintaining and protecting intellectual property;
risks associated with Chiasma’s ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties; the risk that octreotide capsules,
if approved, will not be successfully commercialized; the risk of
competition from currently approved therapies and from other
companies developing products for similar uses; risks associated
with Chiasma’s financial position, including its ability to manage
operating expenses and/or obtain additional funding to support its
business activities; risks associated with Chiasma’s dependence on
third parties; and risks associated with defending any litigation,
including the risk that we incur more costs than we expect and
uncertainty involving the outcome. 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 June 30, 2017 filed with the Securities and Exchange
Commission (SEC) on August 10, 2017, 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
Chiasma (NASDAQ:CHMA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Chiasma (NASDAQ:CHMA)
Historical Stock Chart
From Sep 2023 to Sep 2024