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M P OW ER ED TO
INVEST IG ATE P OTENT IAL
NEW OP T IONS IN
AC R OM EG ALY
The MPOWERED clinical study is being
conducted to compare the safety and
effectiveness of an investigational new
drug product, oral octreotide capsules,
to existing injectable medications
(octreotide and lanreotide) for the
maintenance treatment of acromegaly.
Your doctor can help you determine
whether you may be a candidate for the
MPOWERED study.
CHIASMA: TRANSFOR M ING TR EATM ENTS ,
TRANSFORMING L IVES
Chiasma, Inc. is a biopharmaceutical company focused on
improving the lives of patients suffering from orphan diseases
by developing and commercializing novel oral forms of
therapies that are available today only by injection.
© 2016 Chiasma, Inc. All rights reserved.
Individuals pictured in this brochure may not be acromegaly patients.
CL IN ICAL TR IAL OF AN
ORAL ALTERNAT IVE
INFORMATION FOR PATIENTS AND FAMILIES
CHIASMA®
Individuals pictured in this brochure may not be acromegaly patients.
PAT IENT FAQS
What is a clinical study?
Clinical studies are designed to evaluate the safety and effectiveness of possible new drugs,
medical devices, and medical procedures.
Why is the MPOWERED study being conducted?
The MPOWERED study is designed to compare the safety and effectiveness of an investigational
new drug product, octreotide capsules, to injectable octreotide and lanreotide in patients
with acromegaly.
Who is eligible to enroll in the MPOWERED study?
The MPOWERED study is for patients aged 18-75 who have been diagnosed with acromegaly
and have been treated with the injectable medications octreotide or lanreotide for at least
6 months. You should have had the same dose for at least 4 months, and be adequately
controlled. Your doctor can help you determine whether you may be eligible, or you can contact
the number or visit the website listed on the last page of this flyer.
Why would I consider participating in a clinical trial?
When you participate in a clinical trial, you play a vital role in medical research and may help to
advance treatment for yourself and others with acromegaly. Many patients have reported that being
in a trial made them feel like they were playing a more active role in their own care. Information
from this trial may benefit other patients with acromegaly or similar conditions in the future. Any
medication may have potential side effects. You may experience side effects
from participating in this study.
What are octreotide capsules?
Octreotide capsules are the first oral form of octreotide, an active ingredient that has been used
effectively in injection for acromegaly for many years. Octreotide capsules have the potential to
offer an alternative to injections associated with injectable octreotide and lanreotide. Octreotide
capsules are not yet approved by the US FDA or any other country and are still considered
“investigational,” meaning they are being tested in clinical trials like this one.
What technology allows oral delivery?
Chiasma’s proprietary Transient Permeability Enhancer (TPE®) technology platform potentially
enables the development of oral forms of medications that are currently only available as
injections. TPE protects drug molecules from digestive enzymes and triggers the temporary
expansion of tight junctions between cells of the intestinal epithelium, which is a naturally
occurring process. As a result, drug molecules may pass into the blood stream while larger
structures such as toxins, bacteria and viruses are excluded.
What is the known efficacy and safety of octreotide capsules in acromegaly to date?
As noted, octreotide capsules have not been approved and are investigational new drugs.
The efficacy and safety of octreotide capsules was studied in a 13-month, open-label baseline-
controlled multicenter study in 155 patients with active acromegaly
managed on somatostatin analog injections. 75% of patients
successfully completing dose titration maintained biochemical
control at end of treatment (up to 13 months) and response
was sustained through 13 months in 85%. 80% of patients
completing dose titration reported improvement or
maintenance of symptoms. 86% of those completing 7
months core treatment period elected to continue into
the voluntary 6 month extension phase.
The safety profile was evaluated to be consistent with that of octreotide or lanreotide and the
disease burden of acromegaly, with no new safety signal related to the new formulation or mode
of administration, except for lack of injection site reactions.
What will happen during the study?
Approximately 150 acromegaly patients will participate in the study through sites globally. After a
screening period to see if you are eligible, the study will include 3 parts.
Part 1. A 26-week period to see how you respond to octreotide capsules.
Part 2. A 36-week period where you will either continue to take octreotide capsules or
return to your regular injectable medication. Three out of 5 participants will take
octreotide capsules, and 2 out of 5 will return to their injectable.
If octreotide capsules do not work well enough for you during part 1,
you may be eligible to enter a 36-week combination phase at select sites,
during which you will receive octreotide capsules plus a medication
called cabergoline.
Part 3. Patients who complete the study (regardless of what medication they received)
may be permitted to enter the study extension.
Is there any cost for participating in the study?
No, study medications and study visits will be provided at no cost.
HOW CAN I FIND OUT IF I AM
A CANDIDATE FOR THE MPOWERED STUDY?
FOR U.S. RESIDENTS ONLY
PLEASE CALL TOLL-FREE
1-855-MPOWRED (1-855-676-9733),
VISIT WWW.MPOWEREDTRIAL.COM
OR WWW.CLINICALTRIALS.GOV, OR
SPEAK WITH YOUR DOCTOR.