Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) is having an overwhelmingly positive start to the trading session this morning, and for good reason. The company announced top line data from pivotal Phase 3 clinical trials of its flagship candidate, Lefamulin. Of course, the data was positive, leading to excitement among investors and sending the stock toward the sky. Today, we’ll talk about:
- The data that was released;
- what we’re seeing from NBRV as a result;
- and what we’ll be watching for ahead.
NBRV Heads For The Top On Clinical Data
As mentioned above, Nabriva Therapeutics is having an incredibly strong start to the trading session this morning after the company announced positive clinical data. In a press release issued early this morning, the company announced topline results from the LEAP 2 (Lefamulin Evaluation Against Pneumonia) clinical trial. This trial was the second of two pivotal Phase 3 clinical trials surrounding the treatment. According to the release. LEAP 2 evaluated the efficacy of 5 days of lefamulin in comparison to 7 days of treatment via oral moxifloxacin in adults with moderate community-acquired pneumonia, also known as CABP.
In the release, NBRV said that the study met the United States Food and Drug Administration (FDA) primary endpoint of non-inferiority compared to moxifloxacin for early clinical response. The results were assessed 72 to 120 hours following initiation of therapy in the intent to treat patient population. According to the release, ECR came in at 90.8% for the 5-day treatment course of lefamulin and 90.8% for the 7-day treatment course of moxifloxacin, proving non-inferiority. In a statement, Dr. Jennifer Schranz, CMO at NBRV, had the following to offer:
Today marks an exciting advance in the treatment of CABP as we are one step closer to potentially making a much-needed new class of antibiotics available to patients and health care providers… Lefamulin has the potential to be the first-in-class pleuromutilin antibiotic available for IV or oral administration, and results from LEAP 2 provide additional evidence of its efficacy and tolerability in the treatment of adult patients with CABP. We believe lefamulin is well-suited for the empiric treatment of CABP given its short-course regimen, novel mechanism of action, targeted spectrum of activity against the most common and problematic CABP pathogens, and its safety and tolerability profile. I speak for the entire Nabriva team in acknowledging the participation of the patients, their families, investigators, and research organizations who contributed to the successful completion of this clinical trial.
The above statement was followed up by Dr. Colin Broom, CEO at NBRV. Here’s what he had to offer:
Coupled with our successful LEAP 1 trial, the positive results from LEAP 2 suggest lefamulin could be an excellent empiric treatment option for patients with CABP and help address the problem of antibiotic resistance. With these LEAP 2 results, we believe there is a significant opportunity for oral lefamulin as a 5-day treatment option for CABP in the community… We are especially pleased with the high response rates for lefamulin in LEAP 1 and LEAP 2 and plan to file a New Drug Application with the FDA in the fourth quarter of 2018. With these LEAP 2 results, we have achieved another important and rewarding milestone. My sincere appreciation goes to our highly dedicated Nabriva team who have worked diligently for over a decade to develop this novel antibiotic for patients in need.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In this particular case, the news proved to be overwhelmingly positive. After all, the strong clinical data will likely be what Nabriva Therapeutics needs in order to submit, not only an NDA with the FDA, but to submit the treatment to the EMA as well. So, it’s no surprise that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:12), NBRV is trading at $6.14 per share after a gain of $0.71 per share or 13.08% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, teh CNA Finance team will continue to keep a close eye on NBRV. In particular, we’re interested in following the story surrounding lefamulin as the treatment seems to be a promising candidate when it comes to the fight against pneumonia. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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