The positive results from this trial set the company up to file a supplemental new drug application in the first half of 2019 for community-acquired bacterial pneumonia.
On Monday (October 29) Melinta Therapeutics (NASDAQ:MLNT) released positive Phase 3 clinical trial results from its approved product Baxdela (delafloxacin), for a new indication, community-acquired bacterial pneumonia (CABP).
According to the announcement, the drug was previously approved to treat bacterial skin and skin structure infections (ABSSSI). The positive results from this trial set the company up to file a supplemental new drug application (sNDA) in the first half of 2019 for CABP.
The multi-center global trial was tested against Merck’s (NYSE:MRK) Avelox (moxifloxacin) and met all primary and secondary objectives of the trial. The primary endpoint was an early clinical response (ECR) of 96 hours after the first treatment. Baxdela reached roughly the same ECR rate as moxifloxacin from 88.9 percent versus 89 percent, respectively.
“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,” John Johnson, interim CEO of Melinta, said in the press release.
Chief medical officer at Melinta, Sue Cammarata, added she looks forward to further development and potential regulatory approvals for the drug and other life-threatening infections.
The press release notes the ECR was effective for chest pain, frequency or severity of cough, difficulty breathing and the amount of sputum production, which is the coughed up mixture of mucus and saliva.
The secondary objective of the trial was to meet similar objectives as the competing product based on an assessment of the Success at the Test of Cure visit; this was done five to 10 days after the last dose. Baxdela met this endpoint by 90.5 percent and moxifloxacin at 89.7 percent.
Baxdela had similar side effects to the competing drug, none of which warranted patients to stop the treatment. The drug was administered orally and intravenously (IV) and eliminated the key respiratory pathogens rates.
The US Food and Drug Administration (FDA) has given Baxdela a Qualified Infectious Disease Product for CABP. This means the drug qualifies for certain incentives, such as an extra five years of drug exclusivity for some indications. From the US Food and Drug Administration (FDA) approval in 2017, the company now only needs to file a sNDA based off of this new data.
Melinta Therapeutics solely focuses on developing antibiotics. In addition to Baxdela, it has three other marketed products, Vabomere, Minocin and Orabactiv. The last product is the only one approved by the European Medicines Agency, while other products are awaiting approval or submission. In addition to this CABP indication, Baxdela is also in development for complicated urinary tract infections.
Over the trading period on Monday, Melinta’s stock price decreased by 15.36 percent to close at US$2.37.
Cantor Fitzgerald analyst Louise Chen released a note to investors for the company and reiterated a “Buy” position with a US$15 price target.
Investors are encouraged to follow the company’s new for updated information on this trial. Otherwise, the next milestone for this trial will be submitting the sNDA in the first half of 2019.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.