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Wednesday, June 15, 2022

Immunic: Data From Phase 2 Trial of Vidofludimus Calcium in Relapsing-Remitting MS

Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced that data from its phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS), has been published in the peer reviewed journal, Annals of Clinical and Translational Neurology.

The paper, authored by coordinating investigator, Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, is entitled, "Safety and efficacy of vidofludimus calcium, a selective dihydroorotate dehydrogenase inhibitor, in relapsing-remitting multiple sclerosis (EMPhASIS): a double-blind, randomized, placebo-controlled phase 2 trial." It can be accessed through the following link: https://onlinelibrary.wiley.com/doi/10.1002/acn3.51574.

Vidofludimus calcium is a novel and second generation selective dihydroorotate dehydrogenase (DHODH) inhibitor without off-target effects on kinases seen with drugs of the same class, which may lead to a better safety and tolerability profile. The inhibition of DHODH has been shown to suppress magnetic resonance imaging (MRI) brain lesions and disease activity in multiple sclerosis. The paper assessed the safety and activity on MRI-based endpoints as well as clinical and biomarker assessments of vidofludimus calcium in patients with RRMS.

https://finance.yahoo.com/news/immunic-announces-publication-data-phase-103000738.html

Tuesday, June 14, 2022

Pfizer stops enrollment in Paxlovid trial in standard-risk population

Pfizer Inc said on Tuesday it would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after a study revealed the treatment was not effective in reducing symptoms in that group.

The drug has emergency use authorization for high-risk groups in which it has been effective in reducing hospitalizations and deaths.

The new data, however, showed a 51% relative risk reduction in standard-risk groups, which the company said was not statistically significant.

The standard-risk population usually includes people who do not have health conditions that put them at risk of severe disease and who can recover without the drug.

Pfizer said it will include the new data in the company's upcoming application to the U.S. Food and Drug Administration seeking full approval for the drug's use in high-risk groups. Data from a study in Israel earlier this month showed the drug reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, but was not found to prevent severe illness among younger adults.

More than 1.2 million courses of Paxlovid have been administered in the United States, according to data from the Assistant Secretary for Preparedness and Response under the U.S. Department of Health & Human Services.

https://finance.yahoo.com/news/pfizer-stops-enrollment-paxlovid-trial-203747152.html

CDC: Omicron Subvariants BA.4, BA.5 Increasing in U.S.

A pair of omicron subvariants newly circulating in the U.S. were responsible for more than 1 in 5 coronavirus infections last week, according to estimates from the Centers for Disease Control and Prevention.

More than 21% of new cases last week were attributable to BA.4 and BA.5, according to CDC data. It’s a significant increase from 13% of infections the week prior and 7% the week before that.

Experts expect the pair of highly transmissible omicron subvariants, which were first reported in South Africa, to become dominant in the U.S.

The rise of BA.4 and BA.5 could lead to an uptick in infections or, at the very least, a longer plateau for the latest coronavirus wave.

The U.S. is currently averaging more than 100,000 new coronavirus cases each day, which is believed to be a drastic undercount of the true number. That’s up from an average of about 30,000 new daily cases two months ago. According to the CDC, the majority of Americans should be wearing masks in public indoor spaces or considering the measure.

BA.4 and BA.5 are also increasing globally, according to the World Health Organization. It reported last week that “accumulating evidence from several countries indicates that there has been no observed increase in severity associated with BA.5 and BA.4.”

As BA.4 and BA.5 have increased, the prevalence of other omicron subvariants in the U.S. has gone down. The current dominant strain, BA.2.12.1, decreased from 66% to 64% of infections over the past two weeks. BA.2, or “stealth omicron,” decreased from about 21% to 14% of cases in the same time period.

https://www.usnews.com/news/health-news/articles/2022-06-14/cdc-omicron-subvariants-ba-4-ba-5-increasing-in-u-s

Clovis Highlights Phase 1 Data from Studies of Targeted Radiotherapy

First presentation of initial LuMIERE Phase 1 data demonstrated a manageable safety profile with preliminary evidence of activity
- Nine patients treated to date with 177Lu-FAP-2286 up to 5.5 GBq/dose
- No serious adverse events, treatment discontinuations, deaths or dose-limiting toxicity events related to 177Lu-FAP-2286 observed
- Confirmed partial response in one patient who completed six administrations of 177Lu-FAP-2286 in the 3.7 GBq dose cohort
- Recruitment of the 7.4 GBq dose cohort is ongoing
FAP-2286 has shown high tumor uptake and prolonged retention across a range of solid tumors
Data from a separate UCSF investigator-initiated Phase 1 imaging study of 68Ga-FAP-2286 in solid tumors will also be presented during the meeting

https://finance.yahoo.com/news/clovis-oncology-highlights-phase-1-180000773.html

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