Lexington, Mass.-based Aldeyra Therapeutics Inc.’s phase III win in the study called Invigorate with reproxalap for allergic conjunctivitis (AC) restarted speculation about odds of the drug, a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species (RASP), to treat dry eye disease (DED). “I do think there is potential read-through,” CEO Todd Brady said, especially with regard to the redness endpoint. A six-week safety study necessary before going to the FDA has not yet started, he told investors during a conference call. “That will require some discussions with the FDA, but I do not think, given the length of the trial, the safety study would impair our guidance of potentially filing NDAs by the end of this year.”
The volume of phase I-III clinical trial data so far in 2021 is a full 26% more than it was by this point last year, yet the proportion of news focused on the COVID-19 pandemic continues at much the same rate.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Aldeyra, Alkermes, Ampio, Aravive, Brickell, Discgenics, Fosun, Gila, Logicbio, Lumos, Noxopharm, Obseva, Protagonist, Reithera, Revance, Sifi, Verona.
Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants.
One of the keys to making a schizophrenia drug work is reducing the side effects, which, if they are powerful enough, will often cause patients to cease the treatment. Laxminarayan Bhat, Reviva Pharmaceuticals Holdings Inc.’s CEO, told BioWorld that new phase II data of the company’s lead candidate shows the drop-out rate was low compared to other schizophrenia drugs.
Shares of Inovio Inc. (NASDAQ:INO) fell 25% to $6.85 on April 23 after the company said the U.S. Department of Defense scratched funding for the phase III portion of an ongoing trial of its COVID-19 vaccine candidate, INO-4800, in light of the broad availability of other COVID-19 vaccines in the U.S. The news followed recent phase I data showing '4800 performed about in line with already available competitors against SARS-CoV-2 variants now dominant in the U.S.
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
LONDON – A large scale U.K. study looking at the impact of COVID-19 vaccinations on antibody responses and new infections in 373,402 people in the general population has shown a single dose of vaccine cut infections by 65%. Symptomatic infections fell by 74% and infections with no reported symptoms by 57%, 21 days after receiving the first dose of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s vaccine.
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