Clinical trial results can help support drug developers’ goals. For example, positive trial results may support Marketing Authorization Applications (MAAs) or other areas needed to get therapies into the hands of patients. According to an early January news release from biopharmaceutical company Amryt, positive results are now published from the Phase 3 MPOWERED clinical trial evaluating Mycapssa (oral octreotide) as a maintenance therapy for people with acromegaly.
In particular, the study compared Mycapssa with injectable Somatostatin Receptor Ligands. Overall, the data highlighted the benefits of Mycapssa for acromegaly and added to data from previous CH-ACM-01 and CHIASMA OPTIMAL clinical trials. This helps to support the MAA for Mycapssa in the European Union; the United States’ already approved this treatment.
The published data can be found in The Lancet Diabetes & Endocrinology.
About Mycapssa
To begin, let’s first unpack what this treatment option is. According to the Mycapssa website, Mycapssa is:
the first and only oral somatostatin analog (SSA) for the treatment of patients living with acromegaly [who formerly tolerated or responded to octreotide or lanreotide]. It is an alternative to SSA injections that can eliminate the need for a painful administration [and] was proven to effectively maintain normal IGF-I and GH levels.
Within the Phase 3 MPOWERED clinical trial, researchers evaluated Mycapssa in comparison to injections, which may cause pain or discomfort. Altogether, 146 patients enrolled; 92 patients responded to treatment. Data from the study will help support Mycapssa approval within Europe. Findings include:
- More patients responded to Mycapssa treatment than to injectable Somatostatin Receptor Ligands. A significant amount of patients who received the injectable treatment reported injection site reactions.
- Overall, this therapy was relatively safe and well-tolerated. Some gastrointestinal side effects did occur.
- 15% of those treated with Mycapssa experienced breakthrough acromegaly symptoms. Alternately, 31% of those treated with the injectable therapy experienced symptoms.
- Mycapssa reduced fatigue and inflammation in the extremities.
- Patients treated with Mycapssa reported higher emotional satisfaction and a better quality of life (QOL).
- Both treatment options helped patients maintain disease control over the treatment period.
Acromegaly
An estimated 60 in every 1 million people has acromegaly, a hormonal disorder where the pituitary gland produces too much growth hormone (GH). Adenomas, or benign tumors on the pituitary gland, may cause excess growth hormone. When this occurs after the growth plates are closed, it causes significant and abnormal growth, as well as other potential health effects. Do not confused acromegaly with gigantism; gigantism occurs in children, while acromegaly usually occurs in middle-aged adults. Symptoms and other characteristics of acromegaly include:
- Joint pain
- Hands and feet which appear disproportionately large compared to the rest of the body
- Enlarged nasal bone
- Protruding brow and lower jaw
- Thick, coarse skin
- Excessive sweating
- Severe headaches
- Deepening voice
- Organ enlargement
- Vision impairment
- Type 2 diabetes
- High blood pressure
- Increased risk of respiratory, cardiac, or cerebrovascular conditions
Learn more about acromegaly here.
