Novavax, Inc. (NASDAQ:NVAX) may be on track to achieving the first commercialized drug in a long time. According to a news release, the Phase clinical trial for NanoFlu was a success. Interestingly, the data underscore another positive round of data from a Phase 1/2 study.
NanoFlu surpasses the current standard vaccine
The latest study confirms the efficacy of the dosing of the vaccine as well as its safety. Notably, all participants successfully tolerated all formations of the vaccine. Further, the data noted that the participants’ immune systems correctly reacted to four strains of influenza under study. Interestingly, participants came out of the study with rejuvenated immune responses. Notably, the study enrolled 1,375 participants that were sufficiently healthy. All of them were at least 65 years old.
Novavax develops NanoFlu which is a flu vaccine that targets influenza. Notably, the vaccine utilizes hemagglutination inhibition (HAI) to combat various types of viruses that bring about influenza. In particular, Novavax’s study confirmed the vaccine’s effectiveness against A(H3N2) viruses. According to the company, the vaccine does well against the wild-type viruses that include drifted strains. Another crucial finding was that NanoFlu is much more effective than Fluzone High-Dose which is the standard vaccine currently.
A step closer to production
The announcement of the results is a long journey from last year when Novavax launched the Phase 2 trials. During that period, the company revealed that the study would target dosing and formulation of the vaccine. Interestingly, Stanley C. Erck, President, and CEO of Novavax noted that the initiation of the study was monumental.
Now that another milestone is in the bag, the company is anticipating the commencement of Phase 3. However, this will be contingent on what the FDA will have to say regarding the results for Phase 2 trials. Interestingly, if ‘End of Phase 2’ meeting between Novavax and FDA concludes well, NanoFlu will be one step away from commercialization.
Notably, Phase 3 is critical towards the final design of the vaccine. Further, the phase will determine the pace at which the FDA licenses the commercial production of the drug. However, Novavax is very confident in the success of the vaccine.
“We continue to believe NanoFlu is a differentiated flu vaccine capable of better addressing a global public health problem,” said Erck.