Innovation Pharmaceuticals Inc (IPIX)

[CallMeCrazy]

Bio Seeks EUA Path After Successful C-19 P-2

Cerecor, which has a market cap of less than $400 million and some small, low-key raises and pacts over the years, saw its shares bounce around 15% premarket this morning on new phase 2 data for its experimental COVID-19 drug.

The asset, a monoclonal antibody known as CERC-002, saw top-line data at the start of the year but now has more details. The test breaks down like this: It saw all patients hospitalized with COVID-19 associated pneumonia and mild to moderate acute respiratory distress syndrome.

A total of 83 patients were randomized to get the standard of care at the sites plus either a single dose of 1,200 mg of CERC-002 or placebo subcutaneously; 62 patients were included in the intention-to-treat (ITT) analysis of the primary endpoint.

The trial hit this endpoint, which was the proportion of patients alive and free of respiratory failure over the 28-day study period, compared to placebo, though the p-value was very close, at 0.044, for the ITT population.

The drug performed best in patients over 60 (34 in total), though again, the statistical significance here was tight at a p-value of 0.042. The drug was tested alongside steroids and Gilead’s remdesivir.

At both the 28-day and the 60-day final time points, the biotech said “approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.” The company did not say whether it had tested the drug on newer variants of the SARS-CoV-02 virus, which could dampen the affect of mAbs.

Cerecor has asked the FDA for both breakthrough-therapy and fast-track tags for the med in COVID-19 and plans to meet with the FDA “to discuss the potential path” to an emergency use authorization and approval.

https://www.fiercebiotech.com/biotech/little-cerecor-sees-shares-jump-covid-readout-seeks-eua-though-margins-success-are-thin

You might note that this company, among other things, is seeking fast track designation AFTER their COVID-19 P-2, while Leo acquired this designation BEFORE the end of B-COVID's P-2.

I think this is another sign of Leo's efficiency in the handling of our clinical COVID trial.