The company announced its decision following a meeting with the U.S. Food and Drug Administration.
- While one of the two late-stage trials will be initiated in the second quarter, the second will be kickstarted in the second half of this year, the company said.
- The company also said that it has secured FDA alignment on the remaining early-stage trials needed to support an application to the agency seeking approval.
- Trevi Therapeutics has chosen the initially intended, "safe" path of conducting parallel trials, despite the FDA's guidance of requiring only one pivotal trial, Stifel said.
Shares of Trevi Therapeutics (TRVI) closed12% lower on Monday after the company said that it intends to conduct two late-stage clinical trials for Haduvio in the treatment of chronic cough in patients with idiopathic pulmonary fibrosis.
The company announced its decision following a meeting with the U.S. Food and Drug Administration (FDA). While one of the two late-stage trials will be initiated in the second quarter, the second will be kickstarted in the second half of this year, the company said while adding that it is well positioned to execute the remaining development program.
The company added that it has secured FDA alignment on the remaining early-stage trials needed to support an application to the agency seeking approval.
Trial Design
The trials will both be randomized, placebo-controlled, multicenter, global trials evaluating the safety and efficacy of the tablets. While the first of the two will enroll about 300 patients, the other is expected to enroll about 130 patients. Both trials will gauge relative change from baseline in 24-hour cough frequency. Patients with the condition cough up to 1500 times a day, according to Trevi.
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue. It causes severe breathlessness and a dry cough. Currently there are no FDA-approved therapies for IPF-related chronic cough.
Wall Street Takeaway
Trevi Therapeutics has chosen the initially intended, "safe" path of conducting parallel trials, despite the FDA's guidance of requiring only one pivotal trial, Stifel said, while also noting that it does not believe this will spare a tremendous amount of time regardless. The firm has a ‘Buy’ rating on the shares.
According to data from Koyfin, all eleven analysts covering TRVI rate it ‘Buy’ or higher. The 12-month average price target on the stock is $21.55, representing a potential upside of over 80% from current trading levels.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around TRVI stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume remained at ‘normal’ levels.
TRVI stock has nearly doubled over the past 12 months.
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