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.