Chiasma Announces Positive Topline Results from the MPOWERED™ Phase 3 Clinical Trial Comparing MYCAPSSA® (octreotide capsules) to Long Acting Injectables for the Maintenance Treatment of Adults with Acromegaly
91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial
Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021
Company to host conference call today at 8:00 a.m. ET
The MPOWERED non-inferiority trial was designed to compare long-term maintenance treatment with MYCAPSSA, the first and only approved oral SSA therapy for acromegaly, to the long-acting injectables octreotide long-acting release and lanreotide autogel, in patients previously responding to these therapies. After a six-month run-in phase, 92 patients who were responders to MYCAPSSA were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy.
- The study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained insulin-like growth factor 1 (IGF-1) response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month randomized, controlled treatment (RCT) phase.
- MYCAPSSA maintained mean IGF-1 within normal limits and was comparable to injectable therapy: mean IGF-1 in the MYCAPSSA cohort at the beginning and end of the RCT phase was 0.9 × ULN and 0.9 × ULN, respectively, compared to 0.8 × ULN and 0.8 × ULN, respectively, in the injectable SSA cohort.
“We are excited with the positive results from the MPOWERED study that demonstrated non-inferiority relative to long-acting SSAs. These results further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients with acromegaly,” said
“I am pleased that the MPOWERED study met its primary endpoint of non-inferiority compared to long acting SSA injectables. These results should provide treating physicians with confidence that patients on injectables who are switched to oral octreotide can be expected to achieve comparable efficacy and safety,” commented
MPOWERED™ MYCAPSSA® Safety:
The safety profile of MYCAPSSA capsules in the MPOWERED trial was consistent with the known safety profile of octreotide but without adverse injection site reactions. No new or unexpected safety signals were detected during the study among MYCAPSSA subjects. See Important Safety Information below for contraindications, warnings, precautions and adverse reactions associated with MYCAPSSA based in the current approved labeling in
Conference Call and Webcast Information
Chiasma management will host a conference call and webcast to discuss the results of the MPOWERED study today, November 18, 2020, at
A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company’s website approximately two hours after the event. The archived webcast will be available for one year.
MPOWERED™ Phase 3 Trial Design
The MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA in the
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
Advise premenopausal females of the potential for an unintended pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in
Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve 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. On
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 data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the
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