University of California

THURSDAY, March 6, 2025 -- The antiviral drug Paxlovid may not offer much protection against COVID-related hospitalizations or deaths for vaccinated older adults after all. Research published recently in JAMA Network Open looked at data from more than 1.6 million adults ages 65 to 74 in Ontario, Canada, during 2022. Most participants (nearly 88%) had received at least two doses of the COVID vaccine, and only certain high-risk groups or adults 70 and older were eligible for Paxlovid at the time. The study found that Paxlovid did not significantly reduce the risk of hospitalization or death from COVID in this mostly vaccinated population. “We were surprised and disappointed,” lead study author John Mafi , an associate professor of medicine at the David Geffen School of Medicine at UCLA, told The Washington Post . “We concluded that it’s because it’s a highly vaccinated group with 88 percent fully vaccinated,” he added. The findings could help older adults weigh the benefits and costs of taking Paxlovid. “The cost is part of the calculus because it’s $1,650 per treatment course,” Mafi said. “I think that needs to be part of the conversation.” A spokesperson for Pfizer, which makes Paxlovid, said the company stands by its effectiveness for patients at high risk for severe illness. What's more, Paxlovid may still be helpful for certain high-risk groups, Mafi said. “If you’re immunosuppressed, if you have cancer , chemotherapy , if you are frail, if you’re living in a nursing home, if you have end-stage kidney disease, if you’re an organ transplant recipient, those are very high-risk conditions,” he told The Post . “I would be more cautious in those groups.” Paxlovid, a combination of nirmatrelvir and ritonavir, has been shown to reduce hospitalizations and deaths in unvaccinated, high-risk adults. But prior research found it didn’t significantly shorten COVID symptoms in vaccinated adults. At best, the drug lowered hospitalization risk by 1.3 percentage points in this new study. “If you are vaccinated without additional risk factors, I wouldn’t prescribe Paxlovid, and I probably wouldn’t take it if I was a patient,” study co-author Dr. Peter Wu , associate professor of medicine at the University of Toronto, told The Post . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

The biotech is preparing to meet with the FDA and start a phase 3 program this year. \n Lexicon Pharmaceuticals is yet again defending a mixed set of data on its non-opioid pain prospect. The biotech focused on low-dose results from its latest phase 2 trial, rather than the overall primary endpoint miss, but investors took a much more downbeat view of the data.Texas-based Lexicon published data from two phase 2 trials in 2022. Based on the findings, the biotech dropped the loading dose from the regimen for its third midphase study to improve tolerability. Monday, Lexicon shared topline results from the third study, which compared three regimens of the AAK1 inhibitor LX9211 to placebo in adults with diabetic peripheral neuropathic (DPN) pain.Pooling data from all the treatment arms, LX9211 was no better than placebo at improving average daily pain score (ADPS) after eight weeks. Lexicon blamed the primary endpoint miss on the high-dose cohort.Mean ADPS fell 1.74 and 1.38 points, respectively, in the low- and high-dose cohorts. People who began on the high dose and then switched to the low dose experienced a 1.7-point reduction. The results look solid compared to Lexicon’s earlier DPN trial, when the biotech saw reductions of 1.4 and 1.3 points, respectively. The problem, for Lexicon, is that placebo performed better in the latest trial too. The mean ADPS reduction on placebo in the latest study was 1.31, compared to 0.7 in the earlier trial. The upshot is the placebo-adjusted change at the low dose fell from around 0.7 to 0.4 between the two trials. Analysts were already questioning whether a 0.7-point delta was meaningful. Steve Edelman, a professor of medicine at the University of California San Diego, made the case that the data point was indeed meaningful at a Lexicon event in January.Investors made their own feelings about this morning\'s results clear, sending Lexicon’s share price down 40% to 42 cents when the markets opened Monday. Lexicon is publicly more positive about the study, which, in its eyes, delivered on its goal of identifying a phase 3 dose. Lexicon has seen separation from the control at the low dose in two trials and a placebo-like dropout rate in the latest study.Buoyed by those findings, the biotech is preparing to meet with the FDA and start a phase 3 program this year. Craig Granowitz, M,D., Ph.D., chief medical officer at Lexicon, made the case that the candidate can hit in phase 3 on a call with analysts to discuss the data, noting that increasing enrollment to the 300 to 350 subjects per arm planned for the phase 3 and extending the study’s duration will bring benefits.“We feel pretty confident that first of all, the trends in pain reduction will continue with the treatment arm, especially with a much lower dropout rate and with many more patients,” Granowitz said. “The variance of the data should also shrink, which should improve the statistical reliability of the dataset.”

European Patent Office grants new CRISPR/Cas9 patent (EP 4 289 948) to CVC, with broad claims covering guide RNAs and their combination with Cas9. Patent strengthens CVC's leading position in European CRISPR IP landscape, providing security to over 150 ERS Genomics licensees. DUBLIN and CHESTER, England, Feb. 26, 2025 /PRNewswire/ -- ERS Genomics ('ERS'), which was established to provide broad access to the foundational CRISPR/Cas9 intellectual property developed by Prof. Emmanuelle Charpentier announced today that the European Patent Office ('EPO') has published its decision to grant patent number EP 4 289 948. The divisional patent includes broad independent claims covering single guide RNAs, modified DNA-targeting RNAs and the combination guide RNAs with Cas9. Prof. Charpentier, along with The Regents of the University of California and the University of Vienna (collectively known as CVC), co-owns the patent. John E Milad, CEO of ERS Genomics, said: "The EPO's decision to grant EP 4 289 948 with broad claims reinforces CVC's leadership position in CRISPR IP in Europe and validates our strategic decision to self-revoke two legacy CRISPR/Cas9 patents. This decision provides our 150+ licensees with greater confidence in their rights, while maintaining CVC's established patent leadership in Europe." "We also look forward to the forthcoming decision on CRISPR patent Interference in the US. Regardless of the outcome, we will continue to hold foundational and essential patents that give our licensees protection and allow them to operate with confidence in the field of CRISPR/Cas9. Today's approval by the EPO only further strengthens our position." About ERS Genomics ERS Genomics provides access to the foundational CRISPR/Cas9 intellectual property estate (the 'CVC Patents') co-owned by Prof Emmanuelle Charpentier. A license to the CVC Patents is essential for ensuring freedom to operate when practicing the use of CRISPR/Cas9 in all cells. The CVC Patents include over 130 patents worldwide, with over 50 patents in the US alone, covering over 1,400 claims. Licenses to the CVC Patents are available from ERS Genomics for both research use and commercial applications outside of the direct use of CRISPR as a human therapeutic. ERS Genomics' licenses support a wide range of applications, including life sciences research tools, kits and reagents; discovery of novel targets for therapeutic intervention; development of cell lines for drug discovery and screening; bioproduction of antibodies and therapeutic proteins; advancements in companion animal and livestock health; and diverse synthetic biology applications such as producing enzymes, biofuels and chemicals. Current licensees include GSK, Merck, Bayer, ThermoFisher Scientific, Corteva, Lonza, Taconic, Danaher, PerkinElmer, Charles River Laboratories, Synthego and Cargill. For additional information please visit . Logo - SOURCE ERS Genomics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED