Staggered by a Duchenne patient’s death, Akashi finally gets a green light to get back into the clinic
Akashi Therapeutics was put in limbo more than a year ago after the FDA forced the little biotech to slam the brakes on its development effort for a new drug to treat Duchenne muscular dystrophy following the death of a patient in an early-stage study. But 13 months later Akashi says it now has a green light from regulators to get back into the clinic with HT-100.
Akashi is slashing the dose to 150 µg/day after testing a range that extended from 300 µg/day to 1500 µg/day. And at the time Akashi said that the patient who died was on a high dose of the drug HT-100. The biotech is also ending the use of antiemetic therapies.
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