MYCAPSSA: A Revolutionary Oral Treatment for Acromegaly and Beyond
Introduction to MYCAPSSA
MYCAPSSA, developed by Chiasma Inc. and now part of Amryt Pharma, is a groundbreaking oral formulation of octreotide, a somatostatin analog (SSA). It is the first and only FDA-approved oral SSA therapy for the long-term maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with injectable octreotide or lanreotide[3].
Clinical Trial Updates
MPOWERED Phase 3 Trial
The MPOWERED Phase 3 non-inferiority trial was a pivotal study that compared MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for the maintenance of biochemical response in patients with acromegaly. Here are the key findings:
- Non-Inferiority: The trial demonstrated that MYCAPSSA was non-inferior to long-acting injectable SSAs in maintaining insulin-like growth factor 1 (IGF-1) response. Specifically, 91% of patients on MYCAPSSA maintained their IGF-1 response during the 9-month randomized controlled treatment phase[1][5].
- Symptom Reduction: Patients on MYCAPSSA showed a statistically significant reduction in active acromegaly symptoms, including swelling of extremities and fatigue. The overall mean symptom score decreased significantly, indicating a clinically meaningful improvement[5].
- Safety Profile: The trial revealed no new or unexpected safety signals. Gastrointestinal adverse events were the most common, but the MYCAPSSA group did not experience injection site reactions, a common issue with injectable SSAs[5].
Bioavailability Study for NET Indication
Amryt Pharma has also completed a successful bioavailability study for MYCAPSSA, which supports a planned Phase 3 study in the treatment of patients with carcinoid symptoms due to neuroendocrine tumors (NET). This study demonstrated dose linearity and acceptable safety and tolerability profiles for doses up to 80mg, paving the way for a potential new indication[4].
Market Analysis and Projections
Current Market Landscape
The acromegaly treatment market is expected to grow significantly, driven by increasing product approvals and the need for more convenient and effective treatments. MYCAPSSA, being the first oral SSA approved by the FDA, has a unique position in this market[3].
Market Growth Projections
- CAGR: The acromegaly treatment market is projected to register a Compound Annual Growth Rate (CAGR) of 7.4% during the forecast period from 2022 to 2027[3].
- Regional Growth: The Asia Pacific region is estimated to grow at the highest CAGR, while North America currently holds the largest market share[3].
Market Opportunities for MYCAPSSA
- Acromegaly Market: With its approval in the U.S. and a pending marketing authorization application in the EU, MYCAPSSA is poised to capture a significant share of the acromegaly treatment market[1][3].
- NET Market: The potential approval for treating carcinoid symptoms in NET patients opens up a substantial new market opportunity estimated at $1.9 billion globally, with $1.0 billion in the U.S. alone[4].
Financial Performance and Integration
Following the acquisition of Chiasma by Amryt Pharma, the integration process has been successful, with significant progress in relaunching MYCAPSSA and advancing new growth opportunities. In FY 2021, Amryt reported a 22% growth in revenues to $222.5 million, with MYCAPSSA revenues in Q4 2021 reaching $5.0 million, all of which were U.S.-based[2].
Expert Insights and Quotes
Raj Kannan, CEO of Chiasma, highlighted the significance of the MPOWERED trial results: "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"[1].
Dr. Joe Wiley, CEO of Amryt Pharma, emphasized the potential of MYCAPSSA for NET patients: "Today’s news represents a significant milestone in our plan to develop MYCAPSSA for patients affected by carcinoid symptoms associated with NET. This additional indication for NET, if approved, creates a substantial new market opportunity for Amryt estimated at $1.9 billion globally"[4].
Key Takeaways
- Clinical Efficacy: MYCAPSSA has demonstrated non-inferiority to injectable SSAs in maintaining biochemical response and reducing symptoms in acromegaly patients.
- Market Growth: The acromegaly treatment market is expected to grow at a CAGR of 7.4%, with MYCAPSSA positioned to capture a significant share.
- New Indications: The drug is being explored for treating carcinoid symptoms in NET patients, offering a substantial new market opportunity.
- Financial Performance: Amryt Pharma has seen revenue growth and is advancing the integration and relaunch of MYCAPSSA.
FAQs
What is MYCAPSSA and how is it different from other treatments for acromegaly?
MYCAPSSA is the first and only FDA-approved oral somatostatin analog (SSA) therapy for the long-term maintenance treatment of acromegaly. It differs from other treatments by offering an oral formulation, eliminating the need for painful injections.
What were the key findings of the MPOWERED Phase 3 trial?
The MPOWERED trial demonstrated that MYCAPSSA was non-inferior to long-acting injectable SSAs in maintaining IGF-1 response, reduced active acromegaly symptoms, and showed a favorable safety profile.
What is the potential market opportunity for MYCAPSSA in treating NET patients?
The potential market opportunity for MYCAPSSA in treating carcinoid symptoms in NET patients is estimated at $1.9 billion globally, with $1.0 billion in the U.S.
How has the integration of Chiasma by Amryt Pharma impacted MYCAPSSA?
The integration has been successful, with Amryt making significant progress in relaunching MYCAPSSA and advancing new growth opportunities, including a planned Phase 3 study for NET patients.
What is the current revenue performance of MYCAPSSA?
In Q4 2021, MYCAPSSA revenues were $5.0 million, all of which were U.S.-based, indicating a positive start to the relaunch efforts.
What is the expected CAGR for the acromegaly treatment market?
The acromegaly treatment market is expected to register a CAGR of 7.4% during the forecast period from 2022 to 2027.
Sources
- Chiasma Announces Positive Topline Results from the MPOWERED Phase 3 Clinical Trial - Biospace
- Amryt Announces 22% growth in FY 2021 Revenues to $222.5M - GlobeNewswire
- Acromegaly Treatment Market Size & Share Analysis - Mordor Intelligence
- Amryt Announces Successful Bioavailability Study for Mycapssa® - GlobeNewswire
- Phase 3 Trial Data Shows Positive Results for Oral Treatment of Acromegaly - Endocrine News
