Melinta Therapeutics Inc. (NASDAQ: MLNT) shares dropped on Monday despite the company announcing positive top-line results from its Phase 3 trial of Baxdela (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP). Baxdela was compared to the standard of moxifloxacin across the board in this trial.
Baxdela met all key primary and secondary endpoints in the trial, including the study’s primary U.S. Food and Drug Administration (FDA) endpoint showing Early Clinical Response (ECR) with improvement at 96 hours (±24 hours) after the first dose in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing.
In the intent-to-treat population, IV-to-oral Baxdela met the FDA primary endpoint of statistical non-inferiority (12.5% non-inferiority margin) for the ECR at 96 hours (±24 hours) after initiation of therapy (88.9% ECR in Baxdela patients) compared to IV/oral moxifloxacin (89.0%).
Baxdela also met the FDA secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator’s assessment of Success at the Test of Cure visit (five to 10 days after last dose) in the intent-to-treat population.
John Johnson, interim CEO and director of Melinta, commented:
These are highly encouraging results that demonstrate the important role we believe Baxdela can play in treating adult patients with CABP. We anticipate filing a supplemental new drug application for Baxdela for the treatment of CABP with the FDA in the first half of next year. If approved, it would represent an important addition to Baxdela’s label and expand upon its position as a safe and effective treatment option for patients with ABSSSI in both the hospital and community settings.
Although the results were positive, the stock continued to fall. In the past 52 weeks the stock is down 76%, and in 2018 alone it is down 82%.
Shares of Melinta were last seen down 16% at $2.35 in Monday’s session, with a consensus analyst price target of $12.80. The stock has a 52-week range of $2.30 to $18.20.