Chiasma is developing Mycapssa, an oral therapy, for the rare disease Acromegaly. For many, Acromegaly is caused by the growth of a benign tumor on the pituitary gland, which causes the body to produce too much growth hormone. Symptoms of acromegaly cover enlarged bones of the hands, arms, feet, legs, head, and organs, such as the heart. Untreated, acromegaly can cause serious illness and is life-threatening.
Worldwide, it is estimated there are 69,000 patients with Acromegaly, half of which are in the United States. Acromegaly is usually treated with surgery, but 40% of these surgeries are not successful. In these cases, patients have to receive painful injections to suppress growth hormone for their rest of their lives. Mycapssa will be the first oral treatment option for Acromeglia.
The estimated market for the treatment of Acromegaly is $2.7 billion, half of which is in the United States (U.S.). The cost of treatment is $55,000 to $165,000 per patient per year. Market studies, performed by Chiasma, have indicated a preference to oral treatment instead of multiple injections administered daily. 70% of patients treated with injections experience pain, injection site pain, inflammation, treatment wear off, and loss of independence to name a few. Chiasma's market research was verified in the Chiasma Optimal Phase 3 when 86% of patients volunteered to stay on oral therapy by enrolling in the 6-month extension phase.
The European Union (E.U.) market for Mycapssa is smaller than the U.S but still significant. The E.U. Mpower phase 3 clinical trial data is expected in the 2nd half of 2020. The trial is a comparison of oral capsules to injection standard of care to study the number of patients who maintain their biochemical response. If trial data is positive then it will support a marketing authorization application for potential approval in the E.U.
The data for the U.S. Chiasma Optional phase 3 clinical trial is expected in the 3rd quarter of 2019. If positive, Chiasma will resubmit to the FDA for a new drug application (NDA) by the end of 2019. Chiasma is also seeking approval under the Prescription Drug User Fee Act, PDUFA, in 2020. With PDUFA, the FDA is usually given 10 months to review a NDA. In some cases, if a drug is designated for priority review, the FDA is has six months to review that drug.
Chiasma is planning for a commercial launch of Mycapssa in 2020. The company has enough cash to fund it until the 1st or 2nd quarter of 2020. With a game changing delivery method like Mycappsa, Chiasma can take advantage of being the 1st oral treatment for Acromegaly and take market share from companies producing injection medication.
Disclosure: I am/we are long CHMA.
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