Chiasma Announces FDA Agreement to Redefine Certain Secondary Endpoints in CHIASMA OPTIMAL Phase 3 Clinical Trial
May 14 2018 - 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 announced it has reached agreement
with the U.S. Food and Drug Administration (FDA) to redefine
certain secondary endpoints of its recently initiated CHIASMA
OPTIMAL Phase 3 clinical trial for its octreotide capsules product
candidate, conditionally trade-named MYCAPSSA®, for the maintenance
therapy of adult patients with acromegaly. Chiasma has received a
Special Protocol Assessment (SPA) Agreement Modification letter
from the FDA to formalize these changes.
“We believe the SPA Modification agreement we are announcing
today with the FDA favorably alters the mix of secondary endpoints
to be reviewed by the FDA in evaluating the totality of evidence of
octreotide capsules’ treatment effect,” said Mark Fitzpatrick,
president and CEO of Chiasma. “Through the SPA Agreement
Modification, the original fourth and fifth secondary endpoints in
this pivotal Phase 3 trial have now been redefined to descriptive
statistics measured within each treatment group. The Special
Protocol Assessment for the CHIASMA OPTIMAL Phase 3 trial indicates
the FDA’s agreement that this Phase 3 clinical trial is
appropriately designed to form the primary basis of an efficacy
claim.”
SPA Agreement Modification
Chiasma has reached agreement with the FDA, through a SPA
Agreement Modification letter, to redefine certain secondary
endpoints of its recently initiated CHIASMA OPTIMAL Phase 3
clinical trial for its octreotide capsules product candidate,
conditionally trade-named MYCAPSSA®, for the maintenance therapy of
adult patients with acromegaly. Per the SPA Agreement Modification
letter, the new hierarchical secondary endpoints now include:
- Proportion of patients who maintain growth hormone (GH)
response at week 36, compared to screening;
- Time to loss of response of IGF-1 > 1.0 × upper limit of
normal (ULN);
- Time to loss of response of IGF-1 > 1.3 × ULN; and
- Proportion of patients requiring rescue treatment.
Chiasma had previously communicated that it did not believe that
the superiority of MYCAPSSA would have been demonstrated in two
defined secondary endpoints under the original trial design. Prior
to the SPA modification, the last two defined secondary endpoints
(change from screening to end of treatment in mean GH and the
change in IGF-1 from baseline to end of treatment), would have
compared patients’ response in the octreotide capsules treatment
arm to patients’ response in the placebo treatment arm where the
Company expects a significant number of patients to have withdrawn
to injectable somatostatin analog rescue therapy. Under the
SPA Agreement Modification, between-arm comparisons of these two
descriptive measures will not be made. The Company believes that
this modification agreement is important, because the FDA has
indicated it plans to consider the secondary endpoints in its
evaluation of the totality of evidence of oral octreotide’s
treatment effect. In addition, the original trial design also
included as an exploratory endpoint the proportion of patients
requiring rescue treatment in each treatment arm during the
nine-month, double-blind, placebo-controlled phase. Chiasma
requested, and the FDA has agreed, to move that exploratory
endpoint to the fourth and final secondary endpoint in the
hierarchy.
CHIASMA OPTIMAL Phase 3 Trial
Chiasma is conducting 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
currently has 40 clinical sites activated in CHIASMA OPTIMAL and
continues to anticipate more than 50 clinical sites will be
dedicated to CHIASMA OPTIMAL. Chiasma anticipates the release of
top-line data from this Phase 3 clinical trial by the end of
2019.
Conference Call InformationChiasma will conduct
an investor conference call to discuss the Special Protocol
Assessment Agreement Modification and the CHIASMA OPTIMAL clinical
trial at 5:00 p.m. ET today. A live webcast of the call will be
available in the "News & Investors" section of www.chiasma.com.
The call also may be accessed by dialing (877) 604-1612 or (201)
389-0883. A webcast replay will be available following the
call.
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 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 release
top-line data from the CHIASMA OPTIMAL trial by the end of 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. 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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