Chiasma Achieves 50% of Target Patients Randomized in CHIASMA OPTIMAL Phase 3 Clinical Trial of Octreotide Capsules in Patien...
15 June 2018 - 6:05AM
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 achieved 50%
patients randomized in its international Phase 3 clinical trial,
referred to as “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo
Treatment In MultinationAL centers), of its octreotide capsules
product candidate, conditionally trade-named MYCAPSSA®, for the
maintenance therapy of adult patients with acromegaly. The Company
also announced CHIASMA OPTIMAL has achieved the FDA-required
minimum of 10 patients randomized from the United States.
Chiasma expects CHIASMA OPTIMAL to complete randomization by the
end of 2018 and anticipates the release of top-line data from this
trial in Q4 2019. This timing is consistent with the plans Chiasma
announced at the initiation of the trial.
The CHIASMA OPTIMAL trial 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 trial prior to initiation, in order to
determine if the trial adequately addresses scientific and
regulatory requirements for FDA approval.
“We are encouraged by the clinical progress in our acromegaly
program,” said Mark Fitzpatrick, president and CEO of Chiasma.
“Reaching the midway point for randomization in our CHIASMA OPTIMAL
Phase 3 trial is an important step toward our goal of resubmitting
a New Drug Application with the FDA. This enrollment milestone
demonstrates the tangible progress we are making toward advancing
octreotide capsules as a maintenance treatment for adult acromegaly
patients. We strongly believe in MYCAPSSA as a potential new
treatment option for adult patients with acromegaly.”
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.
CHIASMA OPTIMAL Phase 3 Trial
CHIASMA OPTIMAL 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 × upper limit of normal (ULN)). The patients also must
have confirmed active acromegaly following their last surgical
intervention based upon an elevated IGF-1 at that time of ≥ 1.3 ×
ULN. The trial is being randomized on a 1:1 basis to octreotide
capsules or placebo. Patients are being dose titrated from 40 mg
per day to up to a maximum of 80 mg per day, equaling two capsules
in the morning and two capsules in the evening. Patients meeting
predefined biochemical failure criteria in either treatment arm
during the course of the trial will be considered treatment
failures and revert to their original treatment of injections and
will be monitored for the remainder of the trial. The primary
endpoint of the trial 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. Chiasma
continues to anticipate more than 50 clinical sites will be
dedicated to CHIASMA OPTIMAL. Chiasma now expects the trial to
complete randomization by the end of 2018 and anticipates the
release of top-line data from this Phase 3 clinical trial in Q4
2019.
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 United States by conducting the
Phase 3 CHIASMA OPTIMAL clinical trial under a Special Protocol
Assessment, the number of clinical sites that will be dedicated to
the CHIASMA OPTIMAL 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 complete
enrollment in the CHIASMA OPTIMAL trial by the end of 2018, and its
ability to release top-line data from the CHIASMA OPTIMAL trial in
Q4 2019. 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 MPOWERED Phase 3 clinical trial to
support regulatory approval of octreotide capsules in the E.U.;
risks associated with Chiasma conducting the additional randomized,
double-blind and controlled Phase 3 CHIASMA OPTIMAL 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 patient enrollment
and variability in the number and types of patients available for
clinical trials, which is particularly challenging for orphan
indications, and the risk that the CHIASMA OPTIMAL trial may be
particularly difficult to enroll given the placebo-controlled
design as well as other ongoing clinical trials in adult acromegaly
patients; 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;
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 Annual Report on Form 10-K for
the year ended December 31, 2017 filed with
the Securities and Exchange Commission (SEC)
on March 20, 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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