Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite's lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite.
The basis for the new IND and its Phase 2/3 clinical protocol is the previously-announced Phase 2 data showing that CF101 at a dose of 2 mg orally showed statistically significant (p = 0.03) clinical benefit, as determined by Psoriasis Activity and Severity Index (PASI) scoring, versus a placebo group. Using these efficacy data, and a supporting safety analysis of >700 Phase 2 patients in CF101 clinical trials in inflammatory diseases, Can-Fite assembled and filed the IND. Can-Fite was notified by FDA that the IND was accepted and that clinical testing could proceed.
Dr Pnina Fishman, Can-Fite's CEO, said, "We are extremely gratified that our scientific and clinical efforts have culminated in this important milestone for the company. As part of this IND, we submitted a registration-quality clinical protocol for the treatment of patients with moderate-to-severe psoriasis. We are confident that this protocol has the appropriate design features, clinical endpoints, and statistical power to allow it to serve as the first of two Phase 3 trials that will lead to the approval of CF101 for this indication."
The planned randomized, double-blind, controlled trial will compare 2 dose levels of CF101 to placebo. Approximately 300 patients will be enrolled at multiple centers, and will be treated for 24 weeks. The main outcome assessments (clinical endpoints) are Physician's Global Assessment, Body Surface Area involvement, and PASI.
Psoriasis is a skin condition that affects 2% to 3% of the general population. The disease is manifested by scaly plaques on the skin and in the severe form has a major effect on the physical and emotional well-being of the patients. General anti-inflammatory agents such as topical corticosteroids, methotrexate or phototherapy are only partially effective and are limited by safety issues. Recently, novel biologics targeting the underlying immuno-pathogenesis of the disease have been introduced, such as Enbrel, which blocks the activity of the inflammatory cytokine tumor necrosis factor-α (TNF-α). Still, a significant need remains for novel oral drugs for patients who do not respond to existing therapies or for whom these therapies are unsuitable.
The market share for Psoriasis is estimated at US$ 3.5 billion annually. The oral administration of Can-Fite's CF101, the drug's mechanism of action (suppression of the inflammatory mediator TNF-α) and its excellent safety profile (tested on more than 700 subjects in other trials), support its use for the treatment of psoriasis.
The success in this study adds up to the success in a recently announced clinical study in dry eye patients. In both these studies the patients were treated with CF101 as a stand-alone treatment. Psoriasis, as well as dry eye disease are inflammatory diseases. The success in both these studies points to the potential general efficacy of CF101 in treatment of inflammatory diseases, with very large market potential. Furthermore and most importantly success in these studies validates the technology platform of the company.
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