Chiasma Inc. (NASDAQ:CHMA) has been carrying out a study of MYCAPSSA®. The evaluation was a Phase 3 CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment in MultinationAL centers) open-label extension (OLE). This is an oral therapy treatment, and it helps reduce the affliction of chronic injections in people suffering from rare diseases.
According to VP of medical affairs at Chiasma, William Ludlam, the OLE study is still ongoing and the insulin-like growth factor 1 (IGF-1) levels were maintained within normal limits within the 48week period. The study continues to examine the longer-term safety and efficacy of MYCAPSSA.
Meanwhile, Ludlam says, “All MYCAPSSA responders that entered into the OLE study continued to take MYCAPSSA after an additional 48 weeks, providing further evidence of patient satisfaction and preference for this recently approved oral treatment option.”
The company’s belief in the potential for MYCAPSSA
The fact that patients had maintained mean IGF-1 levels by the end of the treatment is a meaningful promise for them suffering from mean IGF-1 levels. According to Chiasma, MYCAPSSA, the first and only oral somatostatin analog approved by the FDA is likely to become the long-awaited oral therapeutic option for acromegaly people. They do not have to bear the challenges associated with injectable therapies.
The benefit will extend to their physicians and nurses because they will have new treatment options for the prescription. Over time, the physicians have increased their confidence and trust in the use of octreotide.
How soon will MYCAPSSA Become Commercially Available?
There are hundreds of people living with acromegaly and have to bear frustrating experiences. This includes their caregivers. However, with the now approved MYCAPSSA, there is massive anticipation of a change of situation.
Chiasma is expecting to have MYCAPSSA commercially available in the Q 4of 2020. Nonetheless, this wholly depends on how soon the FDA would approve the scheduled manufacturing supplement to the approved NDA. Meanwhile, the company will continue to scale-up its patient services and market access. This could include increasing its customer-facing team in sales to ensure patients have competitive support as they switch to MYCAPSSA.