Chiasma Reports on Significant Progress Made During 2017
January 08 2018 - 09:00AM
Chiasma, Inc. (Nasdaq:CHMA), a clinical-stage biopharmaceutical
company focused on improving the lives of patients with rare and
serious chronic diseases, today provided a review of its
achievements in 2017.
“2017 was a critical year for Chiasma, as we achieved three
significant milestones in the development of octreotide capsules,
conditionally trade-named MYCAPSSA®, our Phase 3 product candidate
for the maintenance therapy of adult patients with acromegaly,”
said Mark Fitzpatrick, president and CEO of Chiasma. “In August, we
announced a Special Protocol Assessment agreement with the FDA,
indicating concurrence by the FDA with the adequacy and
acceptability of critical elements of the protocol for our new
CHIASMA OPTIMAL Phase 3 clinical trial. In September, the first
patient was randomized in that trial. Also in September, we
announced that we had surpassed 50% patients randomized in our
international Phase 3 clinical trial referred to as MPOWERED™.
“As we look ahead to 2018, we are excited about the progress we
are making in the development of MYCAPSSA,” Fitzpatrick continued.
“If approved, MYCAPSSA would become the first oral somatostatin
analog in an injectable-only acromegaly treatment market. We expect
to make significant headway this year toward our ultimate goals of
completing recruitment of 50 patients in the CHIASMA OPTIMAL trial
and randomizing a total of 80 responders to octreotide capsules in
the MPOWERED trial. We strongly believe in our mission and the
promise of MYCAPSSA as a potential new oral treatment option for
adult patients with acromegaly.”
Cash Position Update
Chiasma ended 2017 with approximately $67 million in cash, cash
equivalents and marketable securities, consistent with the
company’s previous expectations. Chiasma projects that, under its
current operating plan, this cash will be sufficient to fund its
operations through the anticipated release of top-line data from
the CHIASMA OPTIMAL Phase 3 trial by the end of 2019 while
supporting the MPOWERED trial in parallel.
About the CHIASMA OPTIMAL Phase 3 TrialChiasma is conducting a
Phase 3 clinical trial under a protocol agreed to by the FDA
through a Special Protocol Assessment (SPA) for the company’s
octreotide capsules product candidate for the maintenance therapy
of adult patients with acromegaly. The trial, referred to as
“CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In
MultinationAL centers), 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 growth hormone (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. Patients are only randomized into the
9-month randomized controlled phase of MPOWERED if they are
qualified as responders (IGF-1 <1.3 x ULN and GH<2.5 ng/mL)
to octreotide capsules in the study at the end of the six-month
run-in phase. 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 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 recently
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 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 Phase 3 CHIASMA 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 and
announcement of top-line and other clinical data and submission of
regulatory filings, including the Company’s ability to release
top-line data from the CHIASMA OPTIMAL trial by the end of 2019 and
the Company’s ability to release top-line data from the MPOWERED
trial in 2020, and the Company’s cash forecasts, including its
expected cash and investment balances as of the end of 2017 and the
expectation that it has sufficient existing cash and investments on
hand to fund its operations through its anticipated release of
top-line data from the Phase 3 CHIASMA OPTIMAL clinical trial by
the end of 2019 and to support the MPOWERED trial in parallel. 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 September 30,
2017 filed with the Securities and Exchange
Commission (SEC) on November 9, 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 Feb 2024 to Mar 2024
Chiasma (NASDAQ:CHMA)
Historical Stock Chart
From Mar 2023 to Mar 2024