InflaRx to launch late-stage IFX-1 study in COVID-19-induced pneumonia

Despite underwhelming preliminary data from an earlier study, InflaRx (NASDAQ:IFRX) initiates Phase III trial evaluating IFX-1 in severe COVID-19-induced pneumonia, subject to regulatory approval.

The Company plans to enroll ~360 patients with COVID-19-induced pneumonia. An interim analysis is planned after enrollment of 180 patients, with the potential for an early stop for efficacy or futility.

In addition to the primary endpoint of 28-day all-cause mortality, other key endpoints include assessments of organ support and disease improvement on the ordinal scale.

It says IFX-1 is a monoclonal anti-human complement factor C5a antibody designed to induce an anti-inflammatory response by blocking the biological activity of C5a.

https://seekingalpha.com/news/3593038-inflarx-to-launch-late-stage-ifxminus-1-study-in-covidminus-19-induced-pneumonia

Allscripts cut to Sell at Goldman

Allscripts (NASDAQ:MDRX) has picked up a rare Sell rating in the U.S. Goldman Sachs analyst Robert Jones cut his rating and price target to $5.50 (from $6.50), implying 24% downside risk, citing its “unfavorable” position in the healthcare IT space and doubts about its growth prospects.

https://seekingalpha.com/news/3593046-allscripts-cut-to-sell-goldman

Gilead secures stake in cancer immunotherapy developer Tizona

Gilead Sciences (NASDAQ:GILD) has agreed to invest $300M for a 49.9% stake in privately held Tizona Therapeutics.

GILD has the option to acquire the remainder of the South San Francisco-based cancer immunotherapy developer for $1.25B.

Tizona’s lead candidate is Phase 1-stage TTX-030, an anti-CD39 monoclonal antibody that it is co-developing with AbbVie for the treatment of solid tumors.

https://seekingalpha.com/news/3593056-gilead-secures-stake-in-cancer-immunotherapy-developer-tizona

Moleculin’s WP1122 shows anti-SARS-CoV-2 effect in new lab tests

Moleculin Biotech (NASDAQ:MBRX) rises ~35% PM in reaction to independent laboratory testing that confirms antiviral activity of WP1122 against coronavirus.

The testing compared the therapeutic effects of 2-DG (the active ingredient in WP1122) alone with those of WP1122, a 2-DG prodrug.

Additionally, the Company has also contracted with the independent lab to conduct preclinical toxicology testing, which is currently under way.

Last month, the company announced repeat testing of candidate WP1122 confirmed its antiviral potential.

WP1122 is a prodrug of 2-deoxy-D-glucose (2-DG). WP1122 is only metabolized once it is inside the cell, enabling much higher tissue and organ concentrations of 2-DG.

https://seekingalpha.com/news/3593064-moleculins-wp1122-shows-anti-sars-covminus-2-effect-in-new-lab-tests

Ironwood revises endpoint in late-stage GERD program

Ironwood Pharmaceuticals (NASDAQ:IRWD) has reached alignment with the FDA on certain updates to its Phase III clinical program evaluating IW-3718 in adults with refractory gastroesophageal reflux disease (GERD).

The primary endpoint for the two identical trials: IW-3718-301 and IW-3718-302 has been changed from the previous responder endpoint to a continuous endpoint.

The primary endpoint is now the assessment of change from baseline to week 8 in weekly heartburn severity scores as compared to the original primary endpoint of an overall heartburn responder.

The original primary endpoint has been moved to become one of the key secondary endpoints, along with a change in weekly regurgitation frequency and the proportion of heartburn-free days.

Ironwood plans to stop enrollment in IW-3718-302 to conduct an early assessment of efficacy. The outcome of this assessment is expected to be reported in Q4.

The company is also in discussions with the FDA regarding its request for long-term safety data for IW-3718 in connection with a NDA submission.

https://seekingalpha.com/news/3593071-ironwood-revises-endpoint-in-late-stage-gerd-program

Enzo Biochem to provide COVID-19 testing at 50+ New York pharmacies

Enzo Biochem (ENZ -0.6%) partners with Community Pharmacy Enhanced Services Network, to provide COVID-19 testing at 52 of the network’s 155 pharmacies across New York State.

The company will provide the full range of services, including reagent manufacturing capabilities, diagnostic instruments, and clinical laboratory services.

https://seekingalpha.com/news/3593117-enzo-biochem-to-provide-covidminus-19-testing-50-new-york-pharmacies

AbbVie’s upadacitinib successful in second pivotal dermatitis study

July 21, 2020

AbbVie (NYSE:ABBV) announces positive results from a Phase 3 clinical trial, Measure Up 2, evaluating Rinvoq (upadacitinib) in patients with moderate-to-severe atopic dermatitis (AD).

The study met all primary and secondary endpoints. The co-primary endpoints were the proportion of patients achieving EASI 75 (75% improvement in symptoms) and clear/almost clear skin at week 16 compared to placebo.

Detailed results will be submitted for presentation at a future medical conference and publication.

An earlier Phase 3, Measure Up 1, was also successful.

About a year ago, the FDA approved the JAK inhibitor for rheumatoid arthritis.

https://seekingalpha.com/news/3593088-abbvies-upadacitinib-successful-in-second-pivotal-dermatitis-study