Policy & Regulation
Can-Fite Implements Interim Analysis for its Phase III Psoriasis Trial with Data Expected 4Q20
1 April 2020 - - Israel-based biotechnology company Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is implementing an interim analysis of the Phase III Comfort trial designed to evaluate the company's drug candidate, Piclidenoson, in the treatment of moderate-to-severe plaque psoriasis, the company said.

Following the independent data monitoring committee's evaluation of the data, Can-Fite expects to announce interim results in the fourth quarter of 2020.

The Comfort Phase III psoriasis study is designed to establish Piclidenoson's superiority compared to placebo and non-inferiority compared to Apremilast (Otezla) in patients with moderate to severe plaque psoriasis.

The randomized, double blind study is being conducted in Europe, Israel, and Canada. The study's primary endpoint is the proportion of subjects who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16.

The secondary endpoints include non-inferiority to Otezla on weeks 16 and 32. A Drug Safety Update Report filed in February 2020 with regulatory agencies reported that Piclidenoson, which has been dosed in over 1,400 patients, is well tolerated and has no emerging safety concerns.

Piclidenoson has been out-licensed for the indication of psoriasis in Canada, South Korea, Spain, Austria, Switzerland, Hong Kong, Macau, Taiwan, and China.

According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach USD 11.3bn by 2025.

Public health epidemics or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19, also known as coronavirus, was reported in Wuhan, China.

While initially the outbreak was largely concentrated in China, it has now spread to several other countries, including in Israel, and infections have been reported globally.

The extent to which the coronavirus impacts the company's operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact.

In particular, the continued spread of the coronavirus globally, could adversely impact the company's operations and workforce, including the company's research and clinical trials and ability to raise capital, which in turn could have an adverse impact on the company's business, financial condition and results of operation.

Can-Fite BioPharma is an advanced clinical stage drug development company with a platform technology that is designed to address multi-bn dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.

The company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis.

Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma, the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis.

Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US Food and Drug Administration.

Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction.
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