In an April 20 research note, Dawson James analyst Jason Kolbert wrote that results from Can-Fite BioPharma Ltd.'s (CANF:NYSE.MKT) Phase 2 trial of Namodenoson for nonalcoholic fatty liver disease with or without nonalcoholic steatohepatitis "look pretty good."
He added that "the consistency of the data from the studies (preclinical and clinical), should support business development interest."
Dawson James has a $9 per share target price on Can-Fite; the stock is currently trading at around $1.75 per share.
Kolbert recapped the study design and provided the results.
This purpose of this multicenter, randomized, double-blinded, placebo-controlled trial involving 60 patients was to determine dose efficacy and safety. Patients were treated twice a day with either 12.5 milligrams or 25 milligrams of oral Namodenoson or a placebo for 12 weeks.
The primary endpoint was effect on inflammation, measured by mean percent change from baseline in alanine transaminase blood levels and safety. The second endpoints included the percent change from baseline in liver fat, as determined by MRI proton density fat fraction.
In terms of safety, study participants tolerated Namodenoson at both doses, and no adverse events were reported. Otitis media occurred in two patients but was deemed to be unrelated to the drug. The four other events that occurred that were drug related were mild and self-limited.
Regarding efficacy of Namodenoson, Kolbert noted that "for a small Phase 2 exploratory study, there appears to be a significant efficacy signal."
Kolbert provided updates on other Can-Fite clinical trials.
The company's COVID-19 trial is now designed. Plans call for it to be randomized, open label, and double armed with Piclidenoson administered plus standard supportive care, compared to standard supportive care alone, in 40 hospitalized COVID-19-infected patients with moderate to severe symptomatic disease.
Patients are to be randomized at a 1:1 ratio to one of the trial arms and treated for up to four weeks. The primary efficacy measures will be time to resolution of viral shedding, time to resolution of clinical symptoms, respiratory function, need for ventilatory support and overall mortality.
Piclidenoson, Can-Fite's lead drug candidate, also is in Phase 3 in two indications: moderate to severe rheumatoid arthritis (the ACROBAT study) and moderate to severe plaque psoriasis (the COMFORT study). Enrollment for both trials is more halfway complete. In both, Piclidenoson "hold great promise as alternative therapies with what appears to be a more favorable side effects profile," Kolbert commented.
Dawson James has a Buy rating on Can-Fite BioPharma.[NLINSERT]
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