Chiasma (CHMA) Stock Flies On Positive Phase 3 Data

Chiasma CHMA Stock News

Chiasma Inc (NASDAQ: CHMA) is running for the top in the market today, trading on early gains of more than 40%. The gains come after the company announced posative data from a Phase 3 clinical trial. Here’s the scoop:

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CHMA Stock Is Up Big On Data

In a press release issued early this morning, Chiasma provided positive top-line data from a Phase 3 clinical trial. The pivotal trial, known as CHIASMA OPTIMAL, was designed to evaluate the company’s octreotide capsules product candidate.

The treatment is being developed as a potential maintenance option for adults with acromegaly. The company plans on branding the product as Mycapssa.

CHMA said that the trial resulted in the treatment meeting its primary endpoint. According to the release, 58% of patients on octreotide capsules maintained their IGF-1 response compared to 19% of patients in the placebo arm.

A Look At The Data

Interestingly, not only was the primary endpoint of the trial met, all secondary efficacy endpoints were met as well. In particular, 78% of patients treated with octreotide capsules maintained their growth hormone levels below 2.5 ng/mL at the end of the core study. Only 30% of placebo treated patients maintained these levels.

CHMA also said that median time to loss of response was not reached for those treated with octreotide capsules. patients in the placebo arm showed a median time to loss of response of 16 weeks.

Moreover, 25% of patients treated with octreotide capsules needed rescue medication with injectable SSAs throughout the time of the study. In the placebo arm, 68% of treatments needed rescue medication.

Finally, Chiasma said that the treatment proved to be safe and well-tolerated.

In a statement, Raj Kannan, CEO at CHMA, had the following to offer:

We are pleased with the positive results from the CHIASMA OPTIMAL trial and we believe this brings us one step closer to making the first oral somatostatin analog (SSA) product candidate available to adults suffering from acromegaly. We plan to submit an NDA by the end of the year with an expected six-month PDUFA review time period.

This News Is Huge

For Chiasma and its investors, the news released today is overwhelmingly positive. Think about it, we’re talking about a success in a pivotal, Phase 3 clinical trial. This means that due to the successful completion of the trial and positive results produced, the company intends on submitting a New Drug Application to the Food and Drug Administration.

That’s a big deal! Should the company receive approval from the FDA, it will be able to market the treatment for use in the United States, the world’s largest market. This is huge considering the fact that according to Grand View Research, the acromegaly market is expected to grow to be worth $2.1 billion by the year 2025, and is already a billion-dollar market. As such, an approval could produce an incredible revenue opportunity for the company.

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