Trial Outcomes & Findings for Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure (NCT NCT01033422)

NCT ID: NCT01033422

Last Updated: 2022-05-12

Results Overview

The mean of the IOP measurements obtained at week 16

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 89 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2022-05-12

Participant Flow

Participant milestones

Measure	CF101 1mg CF101 1 mg orally q12 hours CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks	CF101 2mg CF101 2 mg orally q12 hours CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks	Placebo matching placebo orally q12 hours Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks
Overall Study STARTED	34	32	23
Overall Study COMPLETED	33	28	22
Overall Study NOT COMPLETED	1	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure

Baseline characteristics by cohort

Measure	CF101 1mg n=34 Participants CF101 1 mg orally q12 hours CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks	CF101 2mg n=32 Participants CF101 2 mg orally q12 hours CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks	Placebo n=23 Participants matching placebo orally q12 hours Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks	Total n=89 Participants Total of all reporting groups
Age, Continuous	61.08 years STANDARD_DEVIATION 9.513 • n=5 Participants	55.51 years STANDARD_DEVIATION 13.827 • n=7 Participants	56.26 years STANDARD_DEVIATION 11.303 • n=5 Participants	56.83 years STANDARD_DEVIATION 11.828 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	28 Participants n=7 Participants	20 Participants n=5 Participants	73 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

The mean of the IOP measurements obtained at week 16

Outcome measures

Measure	CF101 1mg n=33 Participants CF101 1 mg orally q12 hours CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks	CF101 2mg n=32 Participants CF101 2 mg orally q12 hours CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks	Placebo n=23 Participants matching placebo orally q12 hours Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks
Intraocular Pressure in mmHg	19.01 Intraocular Pressure in mmHg Standard Deviation 3.001	19.84 Intraocular Pressure in mmHg Standard Deviation 7.662	18.95 Intraocular Pressure in mmHg Standard Deviation 4.237

SECONDARY outcome

Timeframe: 16 weeks

To tabulate and enter the frequency (number) of adverse events during the treatment period of CF 101, by treatment arm.

Outcome measures

Measure	CF101 1mg n=34 Participants CF101 1 mg orally q12 hours CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks	CF101 2mg n=32 Participants CF101 2 mg orally q12 hours CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks	Placebo n=23 Participants matching placebo orally q12 hours Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks
Safety of CF 101	7 Number of events	11 Number of events	10 Number of events

Adverse Events

CF101 1mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

CF101 2mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	CF101 1mg n=34 participants at risk CF101 1 mg orally q12 hours CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks	CF101 2mg n=32 participants at risk CF101 2 mg orally q12 hours CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks	Placebo n=23 participants at risk matching placebo orally q12 hours Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks
Vascular disorders Hypertension	2.9% 1/34	0.00% 0/32	0.00% 0/23

Other adverse events

Measure	CF101 1mg n=34 participants at risk CF101 1 mg orally q12 hours CF101: CF101 1 mg tablets orally every 12 hours for 16 weeks	CF101 2mg n=32 participants at risk CF101 2 mg orally q12 hours CF101: CF101 2 mg tablets orally every 12 hours for 16 weeks	Placebo n=23 participants at risk matching placebo orally q12 hours Placebo for: Matching placebo tablets orally every 12 hours for 16 weeks
Eye disorders Any	0.00% 0/34	3.1% 1/32	8.7% 2/23
Gastrointestinal disorders Any	0.00% 0/34	3.1% 1/32	8.7% 2/23
Infections and infestations Any	11.8% 4/34	9.4% 3/32	4.3% 1/23

Additional Information

Zivit Harpaz

Can-Fite BioPharma Ltd

Phone: 972-3-9241114

Email: zivit@canfite.co.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place