Expects to Report EVOMELA® (melphalan for injection) Fourth Quarter 2021 Unaudited Revenue of Approximately $9.12 Million and Full-Year 2021 Unaudited Revenue of Approximately $30 Million, exceeding guidance
Pipeline Assets Continue to Progress, NMPA Granted CTA Approval for BI-1206; CID-103 Phase 1 Enrolling Patients at French and UK Sites
https://finance.yahoo.com/news/casi-pharmaceuticals-announces-preliminary-fourth-120000626.html
-Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-235, a coronavirus 3CL protease inhibitor (also known as the main coronavirus protease, or Mpro) specifically designed as a once-daily, oral treatment for COVID-19.
"SARS-CoV-2 continues to infect millions of individuals worldwide and new variants are still emerging, highlighting the limitations of current therapies and vaccines for COVID-19. There remains an urgent need for highly potent, oral treatments designed specifically to treat and prevent COVID-19, and we believe that the profile of EDP-235 positions it to potentially be a best-in-class antiviral therapeutic," said Jay R. Luly Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "We are excited to reach this milestone and begin our EDP-235 clinical program, with the first subject being dosed in this Phase 1 study. Looking to the rest of the year, we plan to report data from this study in the second quarter of 2022 and, assuming positive findings, we expect to advance EDP-235 to the next stage of clinical development in the second half of 2022."
This first-in-human Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of oral EDP-235 in single ascending doses (SAD), including a two-part food effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers. All SAD and MAD cohorts will enroll eight participants who will be randomized to receive EDP-235 or placebo in a 3:1 ratio.
https://finance.yahoo.com/news/enanta-pharmaceuticals-doses-first-subject-120000357.html
AstraZeneca PLC said Wednesday that its lupus treatment Saphnelo as been approved in the European Union for the treatment of moderate-to-severe systemic lupus erythematosus, the most common type of lupus.
The London-listed biopharmaceutical company said the approval by the European Commission was based on results from the Saphnelo clinical development program.
Saphnelo is an add-on therapy for the treatment of adult patients with moderate-to-severe, active autoantibody-positive systemic lupus erythematosus, or SLE, the company said.
The company said more patients treated with Saphnelo in clinical trials experienced a reduction in overall disease activity across organ systems and achieved sustained reduction in oral corticosteroid use when compared with a placebo.
Saphnelo has recently been approved in the U.S., Japan and Canada for the treatment of SLE and there are regulatory reviews continuing in additional countries, the company said.
"Saphnelo is the first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade and is the only biologic not restricted to patients with a high degree of disease activity," AstraZeneca said.
The doping case of American sprinter Sha’Carri Richardson, who missed the Tokyo Olympics due to a one-month ban, is different from that of Russian figure skater Kamila Valieva at the Beijing Games, the International Olympic Committee said on Wednesday.
The IOC’s comments come after Richardson, banned last year for a month for testing positive for cannabis, questioned a decision to allow Valieva to continue competing at the Winter Olympics amid an ongoing doping case.
“Every single case is very different. She (Richardson) tested positive on June 19 (2021), quite a way ahead of the Tokyo Games,” IOC spokesman Mark Adams said. The Tokyo Olympics, delayed by a year due to the pandemic, started on July 23.
“Her results came in early order for USADA (U.S. Anti-Doping Agency) to deal with the case on time, before the Games. Ms Richardson accepted a one month period of ineligibility which began on June 28.”
“I would suggest that there isn’t a great deal of similarity between the two cases,” he said.
Richardson was expected to be one of the biggest draws in Tokyo after winning the 100 metres at the U.S. trials. She later said her action to consume cannabis was the result of mourning the death of her mother.
On Monday, however, she demanded an answer from the IOC over Valieva’s continued participation at the Games.
The 15-year-old Russian was tested on Dec. 25, 2021 but her results were reported only on Feb. 8, a day after she had won team gold in figure skating for the Russian Olympic Committee.
No Olympic medals will be awarded at the women’s team event or in the single event if she finishes in the top three of that competition, pending the resolution of her ongoing doping case.
Valieva’s automatic provisional suspension on Feb. 8 was lifted by the Russian Anti-Doping Agency on Feb. 9 and an appeal by the IOC, the International Skating Union and the World Anti-Doping Agency to have it reinstated was rejected by the Court of Arbitration for Sport.
“Can we get a solid answer on the difference of (Valieva’s) situation and mines?” Richardson wrote on Twitter on Monday. “My mother died and I can’t run and was also favored to place top 3. The only difference I see is I’m a black young lady.”
“Failed in December and the world just now know however my result was posted within a week and my name & talent was slaughtered to the people,” Richardson said in another tweet.
https://whbl.com/2022/02/16/olympics-richardson-doping-case-not-similar-to-valievas-ioc/
A Chinese mRNA vaccine candidate showed a sharp drop in neutralising antibody activity against Omicron in a small study, but a booster readily induced antibody production in animal tests, researchers said.
The ARCoV vaccine, jointly developed by the Academy of Military Medical Sciences (AMMS), Suzhou Abogen Biosciences and Walvax Biotechnology, is being tested in an international Phase III clinical trial.
It is China's locally developed mRNA (messenger RNA) vaccine candidate furthest along in trial progress. The country has yet to approve mRNA vaccines developed locally or overseas, but has vaccinated 87.1% of its population using several domestically developed shots based on other technologies.
In a lab study analysing samples from 11 vaccinated people, eight demonstrated "low but detectable" neutralisation activity against Omicron, researchers said in a letter to editors published in the journal Cell Research.
The neutralising antibody level against Omicron showed a 47-fold reduction compared with the level against a "wild-type" that contains no major mutations, said the paper published on Monday.
But in animal tests, a third dose, given about nine months after the second shot, readily induced the production of neutralizing antibodies against Omicron and a wild-type strain, it said.
"Our data presented here clearly demonstrate that a third dose of ARCoV would probably lead to a sharp increase in neutralisation antibodies not only against the WT (wild type) SARS-CoV-2 but also the newly Omicron variant," the study said.
China, which is battling small but constant outbreaks of COVID-19 infections, has boosted around one third of its 1.4 billion people, using non-mRNA shots.
The researchers said they also conducted animal tests on two new mRNA vaccine candidates targeting Omicron and the result showed that the induced antibody levels were comparable to those elicited by the original ARCoV.
A Japanese government delay in rolling out COVID-19 booster shots left it more vulnerable than other rich countries when the Omicron variant brought a surge of deaths, say experts, local governments and a former vaccine czar.
The issue could mean political trouble for Prime Minister Fumio Kishida as nearly 30 per cent of the population is aged 65 or older, and so at greater risk from the coronavirus without the protection of the booster.
Kishida's predecessor stepped down after widespread criticism of his handling of the pandemic and the prime minister's ruling party faces an important test with an upper house election this year.
On Tuesday (Feb 15), Japan saw 236 new fatalities, its worst ever one-day toll from COVID.
Although Japan was comparatively slow to launch its initial vaccination campaign, it ramped it up quickly and by November had the highest vaccination rate within the Group of Seven rich countries.
But then the health ministry stuck to a protocol for an eight-month wait between the first vaccination course and the booster, even as other countries cut the waiting times and local governments, including Tokyo, urged a faster roll-out.
The minimum wait was eventually shortened to six months - still longer than South Korea's three months and Singapore's five. Just 10 per cent of Japan's population has had a third shot, compared with more than 50 per cent in South Korea and Singapore.
Hidekiyo Tachiya, mayor of Soma City in northern Japan and chairman of a national association of municipal leaders, met Kishida in October to press for an early start to boosters.
But none were given out until December, and then only to a trickle to doctors and healthcare workers.
"If they had told us in November, that six months was enough, then in Soma we could have gotten the shots out from December, and for that I feel resentment," Tachiya, who is a physician, told Reuters.
"If it had been faster, there wouldn't have been so much suffering and so many people wouldn't have died."
Authorities in Tokyo also pushed for faster boosters but to no avail.
"We requested this next shot as soon as possible but the government didn't quite agree," Tokyo Governor Yuriko Koike told reporters recently.
A health ministry spokesperson said the eight-month lag between shots was decided by a health sciences council and the system was modified in December and January to respond to the Omicron threat.
The vaccine chief under the previous administration, Taro Kono, said the problem was a slow-moving civil service.
"The failure was the health ministry," Kono, who remains a senior official in the ruling Liberal Democratic Party, told Reuters in an interview.
"I've been telling the Prime Minister's Office, you have to be careful because the health ministry is not going to help you out," he said.
"You really have to whip them to get things moving."
Kono, who has been praised by the public and health experts for his role in the vaccination drive, said intervention was key to getting things done quickly.
He recalled wooing Pfizer executives to ensure faster vaccine deliveries, on one occasion, letting one feed the prime minister's koi fish after a breakfast meeting at the premier's residence, in the hope the gesture would help speed up supplies.
Adding to the booster delay, the Moderna vaccine was not approved as a booster until more than a month after the Pfizer shot was approved. There were not enough supplies of both to distribute evenly and to ensure that people got the same booster as their vaccine, although authorities later recommended people get whichever booster was available.
Regulatory approval for the boosters was done according to the law, the ministry said.
"In a sense, the current situation in Japan is business as usual and the previous administration and minister were exceptional in a positive sense," said Haruka Sakamoto, a physician and public health researcher at Keio University.
With signs the Omicron wave is peaking, the booster programme, which Kishida has pledged to spearhead, is finally gaining steam. The health ministry said this week it would buy and import another 10 million Pfizer doses by March.
While new infections are trending down, fatalities are a lagging indicator, and still climbing. Nearly 2,000 people have died of the coronavirus in Japan in February.
The delay could become a problem for Kishida, said political commentator Atsuo Ito.
"We're the farthest behind the advanced nations," Ito said.
"Korea, right next door, is already starting their fourth shots."
https://www.channelnewsasia.com/asia/japan-omicron-surge-more-deadly-covid-19-booster-delay-2501831
New research out of Israel has just confirmed that the puzzling long-COVID phenomenon, which has caused so much fuss around the world, might be caused by damage to one of the most influential nerves in the human body.
For those among us who aren't familiar with the vagus nerve, it's the 10th cranial nerve, and the longest and most complex in that category. Still, repairing nerve damage will be essential since the nerve exerts control over the gastrointestinal tract, along with the face and chest.
New research is set to be presented at this year’s European Congress of Clinical Microbiology and Infectious Diseases investigates the connection between post-COVID syndrome, also known as long COVID, and the vagus nerve.
This 'pilot study' was authored by Dr. Gemma Lladós and Dr. Lourdes Mateu of the Germans Trias i Pujol University Hospital Badalona, Spain, and its findings will be presented at the congress, taking place between April 23-26 in Lisbon.
The study suggests that vagus nerve damage caused by SARS-CoV-2 dysfunction could be responsible for many of the symptoms of long COVID, including persistent voice problems, difficulty swallowing, dizziness, abnormally fast heart rate - aka tachycardia - low blood pressure and digestive issues.
Here's more on the study's findings from the Jerusalem Post:
Long COVID is a condition characterized by persistent and continuous health issues caused by COVID-19 after the patient has recovered from the initial infections. It can affect nearly every organ in the body, as well as cause a range of mental health and nervous system disorders. Some of the most common symptoms of long COVID include fatigue, headaches, shortness of breath, loss of smell and taste, and muscle weakness.
In order to further understand the phenomenon, the researchers used imaging and functional tests, as well as a morphological and functional evaluation of the vagus nerve, in an assessment of long COVID patients presenting one or more signs of VND.
Out of the 348 patients taking part in the study, two-thirds (228) had at least one symptom of VND among their long COVID symptoms. After the initial assessments were completed, further evaluations were conducted on a test group of 22 patients, all presenting VND symptoms.
Tachycardia and dizziness were two of the most commonly-reported symptoms of long COVID.
Of the 22 subjects analyzed, 20 were women with a median age of 44, and on average the symptoms had been present in the participants for 14 months.
The most frequent VND symptoms presented were diarrhea (73% of subjects), tachycardia (59%), and dizziness, difficulty swallowing, and voice problems (45% each). An additional 14% of patients suffered from low blood pressure.
All in all, 86% of the patients assessed had at least three different VND-related symptoms.
While the findings were revelatory, opening up a new avenue of research for scientists inside and outside Israel, the dynamics driving the vagus nerve damage remain a mystery.
As the exact cause of long COVID and the reason why symptoms present in such a varied way from patient to patient is not currently known, the study’s findings could impact and change the understanding and treatment of the condition significantly going forward.
"In this pilot evaluation, most long COVID subjects with vagus nerve dysfunction symptoms had a range of significant, clinically-relevant, structural and/or functional alterations in their vagus nerve, including nerve thickening, trouble swallowing, and symptoms of impaired breathing," summarized the study's authors.
"Our findings so far thus point at vagus nerve dysfunction as a central pathophysiological feature of long COVID."
But given the prevalence of long COVID this breakthrough will certainly be remembered as a relief for researchers and patients both.
