Biopharma Begins Phase 2 COVID Clinical Trial

Source: Streetwise Reports   03/10/2021

An update on two of Can-Fite BioPharma’s studies involving its lead drug candidate Piclidenoson is provided in a Dawson James report.

In a March 5 research note, Dawson James Securities analyst Jason Kolbert reported that Can-Fite BioPharma Ltd. (CANF:NASDAQ) has begun its Phase 2 trial of Piclidenoson in hospitalized patients with mild to moderate COVID.

In this study, the Israel-based biopharma a total of 40 patients are randomized on a 1:1 basis to receive either Piclidenoson 2 milligrams twice daily or a placebo, plus standard supportive care, for up to 28 days, Kolbert described. On the 29th day, all patients’ clinical and respiratory status will be assessed to determine efficacy of the therapeutic. Metrics to be used will include the number of patients still alive and without respiratory failure as well as the number of patients discharged and not requiring supplemental oxygen.

Kolbert reiterated that Piclidenoson, CanFite’s lead drug candidate, is an A3 adenosine receptor (A3AR) agonist that the biopharma is developing as a treatment for psoriasis and rheumatoid arthritis. However, the therapeutic has also shown potential in other inflammatory diseases, such as Crohn’s.

As such, CanFite has advanced Piclidenoson to a multinational Phase 3 study in psoriasis, called COMFORT, Kolbert noted and summarized the design. Along with Israel, the trial is being carried out in Canada and three European countries.

Based on recommendations by the Independent Data Monitoring Committee, this Phase 3 trial eliminates one dosing group and maintains the sample size of 407. The purpose of COMFORT is to evaluate the efficacy and safety of Piclidenoson administered orally every day versus those of apremilast (Otezla) and placebo in patients with moderate to severe plaque psoriasis.

The primary endpoint will be the number of participants who achieve a Psoriasis Area and Severity Index score of 75 at week 16 versus placebo. The secondary endpoints will include noninferiority of Piclidenoson versus Otezla at week 32.

The analyst highlighted that psoriasis constitutes roughly $9 billion market.

Dawson James rates Can-Fite BioPharma Buy and assigns it a $5 per share target price. The current share price is about $1.90.

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Disclosures for Dawson James Securities, Can-Fite BioPharma, March 5, 2021

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