Search This Blog

Wednesday, September 6, 2023

NRx: Potent Antibacterial Activity v. Common, Antibiotic Resistant Urinary Pathogens

 

  • NRX-101 demonstrated potent antibacterial effect against antibiotic-resistant pathogens in culture medium and in an artificial urine model
  • D-cycloserine (DCS), a key component of NRX-101, was originally developed as an anti-infective in the 1950's but was replaced by antibiotics that have since lost effectiveness against complicated Urinary Tract Infections (cUTI)
  • In an era when 90% of cUTI pathogens demonstrate resistance to standard antibiotics, NRX-101 may prove effective in treating cUTI and preventing urosepsis

Vaxart: Topline Data from Phase 2 Challenge Study of Monovalent Norovirus Vaccine

 Study met 5 of 6 primary endpoints

Vaccine was safe and well tolerated with no vaccine-related serious adverse events (SAEs)

Vaccination led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis (AGE), and a substantial reduction in viral shedding

Conference call today at 5:00 p.m. ET

The Vaxart senior management team will host a conference call to discuss the data, beginning at 5:00 p.m. ET today.

The conference call can be accessed using the following information:

Webcast: Click here
Date: Wednesday, September 6, 2023 – 5:00 p.m. ET
Domestic: 877-407-6184
International: 201-389-0877
Conference ID: 13740946

A replay of the webcast will be available for 30 days on Vaxart’s website at www.vaxart.com following the conclusion of the event.

https://www.biospace.com/article/releases/vaxart-announces-topline-data-from-the-phase-2-challenge-study-of-its-monovalent-norovirus-vaccine-candidate/

Corvus to Start Phase 3 Registrational Clinical Trial in Peripheral T Cell Lymphoma Following Meeting with FDA

Plans to initiate soquelitinib potentially registrational Phase 3 clinical trial in Q1 2024

Company to host conference call and webcast tomorrow at 8:30 a.m. ET / 5:30 a.m. PT

Conference Call Details
Corvus will host a conference call and webcast tomorrow, Thursday, September 7, 2023, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the soquelitinib Phase 3 clinical trial plan and other business updates. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

https://www.biospace.com/article/releases/corvus-pharmaceuticals-confirms-planned-initiation-of-soquelitinib-cpi-818-phase-3-registrational-clinical-trial-in-peripheral-t-cell-lymphoma-following-meeting-with-fda/

Cidara: Janssen to Proceed Under License for Drug-Fc Conjugates Targeting Influenza

 Decision follows promising interim efficacy and safety data from ongoing Phase 1 and 2a trials

Cidara to receive a $7 million milestone payment and is eligible to receive an additional $685 million in milestones, plus royalties


https://www.biospace.com/article/releases/cidara-therapeutics-announces-janssen-s-election-to-proceed-under-its-license-agreement-relating-to-novel-drug-fc-conjugates-targeting-influenza/

CMS Should Monitor Effects of Drug Rebates with Eye Towards IRA: GAO

 While rebates that drugmakers give private insurance plans in exchange for preferred placement over competitors on formularies may lower plan premiums, they don’t reduce beneficiaries’ payments for the drugs, according to a report released Tuesday by the Government Accountability Office.

The GAO report found that rebates have largely gone to a small number of drugs, while insurance plans paid less for highly rebated drugs than beneficiaries.

Beneficiaries spent $21 billion for their Medicare Part D prescription drugs in 2021. However, that same year the private insurance plan providers only accrued a net of $5.3 billion in expenditures, after accounting for the $48.6 billion in rebates that they received from drug manufacturers.

According to the GAO’s analysis, three drug classes dominated this practice in 2021, accounting for 73% of rebates: endocrine metabolic agents such as antidiabetic drugs, blood modifiers and respiratory agents.

Private insurance plan sponsors can negotiate rebates from drugmakers in exchange for securing a spot on the provider’s formulary. Manufacturers, in turn, may offer higher payments for lower beneficiary cost-sharing or a better formulary placement versus its competitors.

While these rebates help lower Medicare spending, they “do not lower individual beneficiary payments for drugs, as these are based on the gross cost of the drug before accounting for rebates,” the GAO concluded in Tuesday’s report. Therefore, these rebates “encourage plans to place higher-gross-cost, highly rebated drugs on their formularies over lower-cost alternatives.”

The GAO recommends that the Centers for Medicare and Medicaid Services (CMS) study how these rebates influence how private insurance plan sponsors design their formularies—and how this, in turn, might affect patients’ access to lower-cost medicines.

By monitoring the effects of rebates, CMS could have “increased visibility into the extent to which rebate and formulary practices are likely to substantially discourage enrollment of certain beneficiaries,” the GAO said, noting that the monitoring of rebates “will be particularly important as the agency implements the provisions of the Inflation Reduction Act of 2022, which will change Part D plan sponsor, beneficiary, and Medicare drug spending responsibility and may affect formulary design and rebates.”

GAO’s Tuesday report comes as the government and the pharmaceutical industry continue to fight over the Inflation Reduction Act (IRA), which according to the congressional watchdog “may change rebate incentives and change the effects rebates have on spending” of Medicare, plan providers and beneficiaries.

Specifically, the GAO said IRA provisions—including those related to drug price negotiation for selected high-cost drugs and limits to beneficiary out-of-pocket spending—may change rebate incentives and change the effects rebates have on formulary design and spending.

Signed into law in August 2022, the IRA seeks to generate some $25 billion in drug cost savings over the next eight years, chiefly by renegotiating the prices for some of the most widely prescribed medications. Last week, the CMS released its list of the first 10 drugs to be subjected to this negotiation program. This includes BMS’s blood thinner Eliquis (apixaban) and Lilly’s diabetes drug Jardiance (empagliflozin).

Pharmaceutical companies have strongly disagreed with the IRA’s Drug Price Negotiation Program, with Merck the first in June 2023 to file a lawsuit that questioned the constitutionality of this provision. It has since been followed by several other large pharma companies such as BMS and AstraZeneca.

https://www.biospace.com/article/cms-should-monitor-effects-of-drug-rebates-with-eye-towards-ira-gao/

FDA Rejects AstraZeneca’s Ultomiris Label Expansion in NMOSD

 The FDA has denied AstraZeneca’s supplemental application for its C5 complement inhibitor Ultomiris (ravulizumab-cwvz), seeking approval for the treatment of adults with neuromyelitis optica spectrum disorder, the company announced Wednesday.

In its complete response letter, the regulator asked AstraZeneca to improve Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) and include a background check for patients’ meningococcal vaccination status or require prophylactic antibiotic use before treatment.

There were no issues with AstraZeneca’s efficacy and safety data for Ultomiris, and the FDA did not request additional analyses of its Phase III findings.

AstraZeneca, through its rare disease unit Alexion, will work closely with the FDA to determine how to best adjust the REMS program, according to Wednesday’s announcement by the company.

Ultomiris is a long-acting monoclonal antibody that works by inhibiting the C5 complement protein, which in turn leads to the sustained and complete suppression of the complement cascade. When left unchecked, the hyperactivation of the complement pathway results in an uncontrollable immune response that also ends up attacking healthy cells.

The mechanism of action won Ultomiris its first FDA approval in December 2018 for paroxysmal nocturnal hemoglobinuria. The intravenous treatment has since picked up several other approvals, including atypical hemolytic uremic syndrome in October 2019 and generalized myasthenia gravis in April 2022.

For its latest application, AstraZeneca used data from the Phase III CHAMPION-NMOSD trial, a global open-label study with nearly 60 patients enrolled. To be eligible, neuromyelitis optica spectrum disorder (NMOSD) patients need to have tested positive for anti-APQ4 antibodies and have had at least one attack or relapse within the last 12 months.

In October 2022, AstraZeneca announced that Ultomiris had met the primary endpoint in CHAMPION-NMOSD, leading to a significant and clinically meaningful 98.6% reduction in the risk of relapse, as compared with an external placebo group. At 48 weeks, there were no cases of relapse in the Ultomiris arm, while only 63% of external placebo comparators were relapse-free at this time point.

NMOSD is a rare and debilitating autoimmune disease characterized by the pathologic and excessive activation of the immune system that damages otherwise healthy tissues and cells in the central nervous system. The disorder manifests as vision problems, intense pain, abnormal skin sensations and impaired coordination and movement. At its most severe, NMOSD can lead to loss of vision, paralysis and premature death.

If approved in this indication, Ultomiris will be indicated for the exact same four diseases targeted by its own Soliris (eculizumab). Both are C5 complement inhibitors, working through similar mechanisms of action and each carrying a boxed warning for serious meningococcal infections.

https://www.biospace.com/article/fda-rejects-astrazeneca-s-ultomiris-label-expansion-in-nmosd/

VBI Vaccines Partner Brii: Topline Interim Results of Phase 2 for Hepatitis B Combo

 

  • BRII-179 (VBI-2601) as an add-on therapy to standard of care PEG-IFNα increases HBsAg loss rate at the end of treatment and 12 weeks follow up

  • Significantly increased seroconversion rate is strongly associated with BRII-179 (VBI-2601) treatment and correlates with the increased rate of HBsAg loss

  • Safety findings are similar to those of PEG-IFNα and BRII-179 (VBI-2601) as previously reported