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Thinly-traded micro-cap biotech Chiasma Inc (NASDAQ:CHMA) is advancing strongly in reaction to a clinical trial readout from the company.
What Happened
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Chiasma announced positive top-line data from a pivotal Phase 3 study dubbed CHIASMA OPTIMAL that evaluated its Mycapssa – octreotide capsules – for the treatment of adults with acromegaly. Acromegaly is a disorder when the pituitary gland produced excess growth hormone during adulthood, leading to increased bone size.
The CHIASMA OPTIMAL trial, a randomized double- blind, placebo-controlled, nine-month clinical trial conducted under special protocol assessment agreement with the FDA, met the primary end point, with 81% patients on Mycapssa maintaining their IGF-1 response compared to 19% of the patients on placebo.
The company also noted that all secondary endpoints were also met.
"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," said Raj Kannan, CEO of Chiasma.
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Somatostatin analog injections, which are used to treat acromegaly, burdens the patients due to injection site pains and reactions. If approved, the oral formulation will be a better treatment option to patients and physicians, Chiasma said.
The originally filed NDA was handed out a complete response letter in April of 2016, with the agency advising the conduct of another clinical trial to provide substantial evidence of efficacy to facilitate approval.
What Next
Chiasma said it plans to submit an NDA for the product candidate by the end of the year, and expects a six-month PDUFA review period.
Chiasma shares were soaring 18% to $7.33 Tuesday morning.
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Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.