Chiasma Presents New Positive Data for MYCAPSSA from Phase 3 Trial MPOWERED™ for the Maintenance Treatment of Acromegaly at ENDO 2021
--Data supports MYCAPSSA® as non-inferior to long-acting injectable somatostatin receptor ligands (iSRLs)--
--Data demonstrated patients taking MYCAPSSA had significant improvement in acromegaly related symptoms and patient reported outcomes after switching from iSRLs--
“The new encouraging data from all five late-breaking poster presentations further expand our understanding of oral octreotide capsules’ potential positive impact for patients with acromegaly who would otherwise need monthly, frequently burdensome SRLs injections,” said
Data highlights from the five late-breaking poster presentations are outlined below:
A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules In Comparison to Injectable Somatostatin Receptor Ligands
- Data showed that MYCAPSSA demonstrated non-inferiority to iSRLs in maintaining biochemical response, 91% (CI, 80%-97%) of the MYCAPSSA patients maintained insulin-like growth factor 1 (IGF-1) response during the randomized controlled treatment (RCT) phase.
- MYCAPSSA demonstrated stable IGF-1 levels during the RCT phase comparable to iSRLs, supporting efficacy of MYCAPSSA.
Oral Octreotide Capsules Lowered Incidence and Improved Severity of Acromegaly Symptoms Compared to Injectable Somatostatin Receptor Ligands—Results from the MPOWERED Trial
- A statistically significant (p = 0.001) reduction from baseline (time of first dose of MYCAPSSA in run-in) was noted in the number of active acromegaly symptoms. Reduction in the number of active symptoms by individual symptom was statistically significant for swelling of extremities (p = 0.01) and fatigue (p = 0.03).
- The overall mean symptom score decreased from 4.5 to 3.5; the mean change from baseline was statistically significant (p < 0.001) and clinically meaningful (> 1 point reduction is equal to a shift of 1 symptom from severe to moderate, or moderate to mild or resolution of 1 symptom).
- Overall, 80.4% of the randomized patients maintained or improved their symptoms score during the run-in phase compared to baseline.
- We believe these findings validate previous results from the open-label, Phase 3 CH-ACM-01 study of MYCAPSSA in which patients switching to MYCAPSSA from iSRLs reported significant reduction in joint pain, extremity swelling and fatigue.
Improved Acromegaly Patient Satisfaction with Oral Octreotide Capsules Compared with Injectable Somatostatin Receptor Ligands in The MPOWERED Trial
- For the 92 patients randomized, 3 of 5 domains (emotional reaction, treatment convenience, and treatment satisfaction) of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) showed significant improvement at the end of the run-in (n=37) phase (reflecting outcomes on MYCAPSSA) as compared to baseline (reflecting outcomes on iSRLs). Improvements not reaching statistical significance were also noted for symptom interference and GI interference.
- Patients receiving MYCAPSSA demonstrated a significant improvement in the Acro-TSQ domain of treatment convenience over the RCT phase in comparison to those receiving iSRLs (p = 0.04).
- At the end of the RCT phase, breakthrough acromegaly symptoms were reported by 15% of patients in octreotide capsules group and 31% of patients in the iSRLs group.
- Of note, 47% of patients receiving SRL injections during the RCT phase reported injection site reactions via the Acro-TSQ. 81% of these patients reported that iSLRs interfered with their daily activities.
Addition of Cabergoline to Oral Octreotide Capsules May Improve Biochemical Control in Patients with Acromegaly Who Are Inadequately Controlled with Monotherapy
- IGF-1 levels improved in most patients over the 36-week study (n=12; 85.7%).
- Of nine patients with IGF-1 ≥1.3 × ULN at sub-study start, five patients (55.6%; 95% CI, 21.2% -86.3%) exhibited decreases to predefined responder range (<1.3 × ULN) by week 36.
- Adverse event incidence and nature were similar to the known octreotide safety profile and acromegaly disease burden.
- For the first time, a study demonstrated the potential benefit of an all-oral combination treatment for acromegaly with avoidance of injection-related burdens.
Safety Results From MPOWERED, A Phase 3 Trial of Oral Octreotide Capsules in Adults with Acromegaly
- No new or unexpected safety signals were identified during the trial.
- 39 patients (70.9%) in the MYCAPSSA group and 26 (70.3%) in the iSRL group had ≥1 treatment-emergent adverse events (TEAE). Gastrointestinal AEs were the most common TEAEs within both groups.
- Safety results were similar between both groups, but the MYCAPSSA group did not have injection site reactions, whereas 24.3% of patients reported injection site reactions as TEAEs from the iSRL group during the RCT phase.
About the CHIASMA MPOWERED™ Trial
The MPOWERED™ trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA® (oral octreotide capsules) 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 the
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. In
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
Investor Relations and Corporate Communications: