1. Clinical Study Objectives
The goal of this clinical trial report is to examine the safety and efficacy of GS441524 based oral capsules by CUREFIP™ for the treatment of cats with various types of naturally acquired feline infectious peritonitis (FIP). Oral treatment is a desirable treatment option for cats that experience difficulties with subcutaneous injections.
This clinical trial report begins with a summary of the results from the first 30 days of treatment, which were reported in a previous article, and continues with a detailed report of the results from the second 30 days of the treatment. The total length of the treatment for this clinical trial is 60 days long.
43 infected cats participated in our clinical study. All cats are clinically diagnosed FIP by veterinarians.We aimed to reproduce the natural conditions under which oral capsules may be used by cat owners during a FIP treatment. Thus, the clinical trials were conducted at homes, and administered daily by cat owners instead of veterinary professionals.
All oral forms of GS441524 currently sold on the market are in compressed powder tablets. We selected oral capsules over tablets for the following reasons. Capsules are easy to administer as they are odourless and tasteless. Capsules cause less gastrointestinal irritations. Most importantly, should it be difficult to insert the capsules into the cat's mouth, cat owners can open the capsules and mix the content with cat food or snacks.
Cat owners who participated in our clinical trial study administered the oral capsules using 3 methods:
Insert the capsules directly to the back of the mouth.
Mix capsules in with wet cat treats or wet cat food during feeding sessions.
Separate the gel caps and pour the content on top of the cat food.
Cats that meet the requirements were admitted to the program. Their owners were given 30 days of oral capsules according to their weights, and were instructed to provide one capsule daily at a regularly scheduled time and to update a daily progress tracking sheet. At the end of the first 30 days cats owners were instructed to complete a blood test and send us a copy for review in order to obtain another 30 days of oral treatment. At the end of the second 30 days, cat owners were instructed to complete a third blood test before exiting the clinical trial.
2. A Summary of the first 30 days of treatment
At the end of the first 30 days of treatment, 13 cats showed sufficient improvements to warrant ending the oral treatment. At the time of this writing, all 13 cats are in good health and show no signs of relapse or symptomatic regressions. 2 cats went permanently missing after they were allowed to roam outdoors. Before the disappearance, both cats showed clear improvements. 3 cat owners stopped updating daily progress reports and stopped responding to our inquiries. The remaining 25 cats showed marked improvements but were not ready to exit the treatment program at the end of the first 30 days.
For a summary of the first 30 days clinical results, please click on the following link: https://www.curefip.com/post/fip-clinical-trial-report-after-30-days-of-oral-treatment
3. RESULTS & DISCUSSION
3.1 TREATMENT OUTCOME
After the second 30 days of oral treatment, 24 additional cats successfully exited the treatment. In total, 37 of the 43 cats successfully exited the treatment program within 60 days.
Table 2 shows globulin and albumin/globulin ratio before starting our oral treatment, and after 30 days and 60 days after starting with our oral treatment.
Cat Code | Globulin Reading (pre-treatment) | A/G Ratio (pre-treatment) | Globulin Reading After 30 Days | A/G Ratio After 30 Days | Globulin Reading After 60 Days | A/G Ratio After 60 Days |
COT003 | 4.6 | 0.6 | 4.3 | 0.7 | No Data | No Data |
COT004 | 5.7 | 0.5 | 5.4 | 0.5 | No Data | No Data |
COT007 | 4.3 | 0.6 | 4.5 | 0.6 | 4.9 | 0.7 |
COT008 | 5.4 | 0.5 | 6.4 | 0.5 | 5.8 | 0.5 |
COT009 | 6.1 | 0.5 | 5.9 | 0.6 | 4.8 | 0.7 |
COT010 | 7.1 | 0.4 | 6.1 | 0.5 | 6.0 | 0.4 |
COT011 | 5.7 | 0.63 | 5.5 | 0.6 | 5.4 | 0.6 |
COT012 | 6.8 | 0.4 | 5.2 | 0.5 | 5.4 | 0.6 |
COT014 | 6.5 | 0.3 | 6.5 | 0.4 | 7.3 | 0.4 |
COT015 | 7.0 | 0.4 | 6.1 | 0.4 | No Data | No Data |
COT016 | 5.4 | 0.5 | 4.9 | 0.6 | No Data | No Data |
COT017 | 8.9 | 0.3 | 6.1 | 0.5 | 6.0 | 0.5 |
COT018 | 9.0 | 0.6 | 5.5 | 0.6 | 5.5 | 0.5 |
COT019 | 3.8 | 0.6 | 5.5 | 0.6 | 4.7 | 0.7 |
COT023 | 5.6 | 0.5 | 5.7 | 0.5 | 5.4 | 0.5 |
COT029 | 8.9 | 0.3 | 6.5 | 0.4 | 5.3 | 0.5 |
COT032 | 9.5 | 0.2 | 7.5 | 0.4 | No Data | No Data |
COT033 | 6.3 | 0.4 | 8.3 | 0.4 | 7.7 | 0.3 |
COT034 | 7.4 | 0.26 | 6.9 | 0.23 | No Data | No Data |
COT036 | 7.5 | 0.4 | 6.1 | 0.46 | 4.9 | 0.6 |
COT037 | 7.3 | 0.4 | 5.4 | 0.5 | 4.5 | 0.6 |
COT038 | 7.5 | 0.4 | 5.7 | 0.5 | No Data | No Data |
COT042 | 3.7 | 1.1 | 3.7 | 1.1 | 5.0 | 0.7 |
COT043 | 9.0 | 0.3 | 6.7 | 0.4 | No Updates | No Updates |
COT044 | 6.0 | 0.5 | 5.2 | 0.6 | 5.1 | 0.6 |
Table 2
The normal range of globulin readings is 2.8 - 4.8, while a good A/G ratio is 0.6 and above. After 60 days of oral treatment, the A/G ratio increased in both effusive (wet) and non-effusive (dry) FIP infected cats
As illustrated by Table 2, 4 cats had a slight increase in globulin readings after the second 30 days of treatment, 1 cat globulin remained unchanged while 12 cats showed a decline in globulin readings after additional 30 days of treatment. A few participants did not produce blood tests after 60 days of oral treatment due to financial reason. Participants without the blood tests are doing very well physically based on the daily updates by their owners. All participants illustrated in Table 2 are able to eat on their own without the need of force feeding. COT015 was doing very well until day 42 when the owner decided to spay it. After the procedure, the COT015 had an immediate relapse. COT015 finished 60 days of oral treatment and then continued on with GS injections.
GRAPH 1 shows the different reading of globulin after 30 and 60 days treatment.
GRAPH 2 shows the readings of albumin/globulin ratio after 30 and 60 days treatment.
3.2 WEIGHT CHANGE (WET & DRY FIP)
Cat Code | Weight Before Treatment(Kg) | Weight After 30 Days Treatment(Kg) | Weight After 60 Days Treatment(Kg) |
COT003 | 2.7 | 3.13 | No Data |
COT004 | 3.45 | 3.63 | No Data |
COT007 | 2.50 | 2.7 | 3.1 |
COT008 | 5.70 | 5.9 | 6.3 |
COT009 | 2.55 | 2.7 | 2.85 |
COT010 | 4.00 | 4.26 | 5.03 |
COT011 | 3.20 | 3.3 | 3.4 |
COT012 | 1.87 | 2.27 | 2.41 |
COT014 | 2.84 | 3.33 | 3.96 |
COT015 | 2.34 | 3.09 | No Data |
COT016 | 2.45 | 3.0 | 3.1 |
COT017 | 4.02 | 4.36 | 4.5 |
COT018 | 4.3 | 3.88 | 4.2 |
COT019 | 3.88 | 4.4 | 4.6 |
COT023 | 2.54 | 2.74 | 2.8 |
COT029 | 2.4 | 3.51 | 3.95 |
COT032 | 4.5 | 4.65 | 5.2 |
COT033 | 2.9 | 3.4 | 3.5 |
COT034 | 2.64 | 2.71 | No Data |
COT036 | 1.76 | 2.1 | 2.44 |
COT037 | 2.55 | 2.8 | 3.91 |
COT038 | 2.7 | 2.8 | 2.95 |
COT042 | 4.1 | 4.15 | 4.3 |
COT043 | 3.3 | 3.63 | No Updates |
COT044 | 3.2 | 3.9 | 4.2 |
Table 3 shows the readings of participants' weight after 30 and 60 days treatment.
Graph 3 shows participants' weight after 30 and 60 days treatment.
According to graph 3, all cats showed steady increase in weight. This indicates that cats' appetite has returned after starting oral treatments. Daily progress logs reveals that cats are regaining their appetite and experienced steady weight gains.
3.3 CASES WORTH MENTIONING
1 cat owners stopped communicating with us and stopped updating their daily progress report. 1 cat (COT034) died during the second 30 days of treatment. The cat owner had to go on a business trip and lounged the cat in a clinic. The cat passed away the next day. The owner didn’t consent to a post-mortem analysis to the cause of death. Base on the daily progress report this cat was eating and pooping regularly. However, the cat showed neurological symptoms throughout the treatment period. On the 38th day, the owner reported that the condition of his cat has improved drastically from the beginning of treatment. However, we strongly suspect that cat (COT034) did not absorb sufficient amounts of the antiviral drug GS-441524, thus was under dosing throughout the entire treatment period. In retrospect, this cat was not an ideal candidate for the oral treatment. A more correct treatment program should have began with injections for at minimum 30 days before switching to oral capsules for the reminder of the treatment period.
4. CONCLUSION
Based on the data we gathered from our clinical trial, CURE FIP™ oral capsules appeared highly effective treating cats with light to mild symptoms of feline infectious peritonitis. 13 cats fully recovered within 30 days of treatment. 24 cats fully recovered after 60 days of treatment. 3 cats’ owners stopped communicating with us during the treatment, 2 cat went missing, and 1 cats passed away. All cats showed steady progress towards recovery until communications stopped as according to the blood test reports and daily progress report.