Can-Fite BioPharma Ltd. announced it has submitted its Phase 3 clinical trial protocol to the Institutional Review Board (IRB) of Barzilai Medical Center in Israel, and will also file similar submissions in Europe, Canada and United States.
This serves as an important milestone toward initiating the pivotal Phase 3 trial of its leading candidate CF101 in the treatment of rheumatoid arthritis (RA).
CF101 is a novel AR adenosine receptor agonist (A3AR) small molecule, taken orally, with a favorable therapeutic index proven in Phase 2 clinical trials. CF101 is currently planned to be evaluated in a Phase 3 clinical trial for RA and has concluded Phase 2 and 3 clinical trials for psoriasis, as well.
The Phase 3 protocol submission comes after an important meeting with the Medical Products Agency (MPA) in Sweden which focused on the European registration of CF101 to treat RA after Can-Fite presented data from its Phase 2 clinical trials, along with the drug’s clinical registration strategy. Details of the Phase 3 trial were discussed and Can-Fite agreed to follow MPA’s expectations regarding treatment duration, placebo management, dosing and study endpoints.
Can-Fite now wishes to conduct a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of CF101 based on ACR20 response (a measure based on the American College of Rheumatology criteria of at least a 20 percent improvement in the number of tender and swollen joints, and a 20 percent improvement in at least three other measurements).
The drug is to be administered orally twice a day over 16 weeks to 456 patients with active RA who are currently being treated with conventional drugs. The high number of patients is for robust, statistically significant data.
The study will be separated into three subcategories:
- A 1 mg CF101 dose;
- A 2 mg CF101 dose;
- A placebo control.
All three will be taken twice a day. The A3 adenosine receptor biomarker will be evaluated before the treatment and the correlation with patients’ response to the drug will be scrutinized after the end of the trial.
“We are now concluding the preparatory work to file our Phase III protocol with the European Medicines Agency (EMA) in the first quarter of 2016,” Dr. Pnina Fishman, Can-Fite CEO, said in a press release. “Our newly strengthened cash position following our recent fundraisers, totaling approximately $14 million, is intended to support this pivotal trial.”