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GS-441524 ORAL CLINICAL TREATMENT REPORT (Part II) : AFTER 60 DAYS OF TREATMENT

Updated: Jan 18


1. Clinical Study Objectives

The purpose of this clinical trial report is to evaluate the effectiveness and safety of CUREFIP™'s GS441524-based oral capsules for treating cats with naturally acquired feline infectious peritonitis (FIP). This treatment option is particularly beneficial for cats that experience difficulties with subcutaneous injections.


The report provides an update on the trial's progress, focusing on the results of the second 30 days of treatment, with a total treatment duration of 60 days. The study involved 43 cats diagnosed with FIP by veterinarians, with the goal of simulating real-world conditions where cat owners would administer the treatment at home.


Unlike other GS441524 products on the market, which come in compressed powder tablets, we chose to use oral capsules due to their ease of administration. Capsules are tasteless and odorless, and are less likely to cause gastrointestinal issues. Additionally, if necessary, cat owners can easily open the capsules and mix the contents with their cat's food or snacks.



Cat owners who participated in our clinical trial study administered the oral capsules using 3 methods:

  1. Insert the capsules directly to the back of the mouth.

  2. Mix capsules in with wet cat treats or wet cat food during feeding sessions.

  3. Separate the gel caps and pour the content on top of the cat food.

Cats meeting the program's eligibility criteria were enrolled. Their owners received oral capsules for 30 days, based on the cat's weight, and were instructed to administer one capsule at a regular time each day, while tracking the cat's progress on a daily basis. After the initial 30-day period, the owners were required to complete a blood test and provide us with a copy for review. Upon review, the cats were eligible for another 30 days of oral treatment. At the end of this period, the owners were asked to complete a third blood test before withdrawing from the clinical trial.


2. A Summary of the first 30 days of treatment

Thirteen cats demonstrated significant improvement at the end of the initial 30-day treatment period, resulting in the discontinuation of their oral treatment. As of the writing of this report, all 13 cats remain healthy with no signs of relapse or regression in symptoms. Unfortunately, two cats went missing after being allowed to roam outside, despite showing clear improvement prior to their disappearance. Three cat owners stopped providing daily progress reports and did not respond to our inquiries. The remaining 25 cats showed significant improvement but required further treatment beyond the initial 30 days.


For a summary of the first 30 days clinical results, please click on the following link: https://www.curefipoceania.com/post/fip-clinical-trial-report-after-30-days-of-oral-treatment


3. RESULTS & DISCUSSION

3.1 TREATMENT OUTCOME

Following the completion of the second 30-day oral treatment period, 24 more cats successfully completed the treatment and exited the program. Overall, 37 out of the 43 cats were able to complete the treatment within the 60-day duration of the program.


Table 2 displays the globulin levels and albumin/globulin ratio before initiating the oral treatment, as well as the corresponding values at 30 days and 60 days after commencing the 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 for globulin readings is typically 2.8-4.8, with a desirable A/G ratio of 0.6 or higher. After completing 60 days of oral treatment, both effusive (wet) and non-effusive (dry) FIP-infected cats demonstrated an increase in A/G ratio.


As outlined in Table 2, four cats experienced a slight increase in their globulin readings after the second 30 days of treatment, while one cat maintained the same level, and twelve cats showed a decline in globulin readings following an additional 30 days of treatment. Due to financial reasons, some participants were unable to provide blood test results after the 60-day oral treatment period. However, based on daily updates from their owners, these participants are doing well physically. All of the participants listed in Table 2 are capable of eating on their own without the need for force feeding. Unfortunately, COT015 experienced a relapse after being spayed on day 42, but still completed the full 60 days of oral treatment before continuing with GS injections.


FIP Treatment Globulin Readings
Globulin readings after 30 and 60 days treatment

GRAPH 1 shows ​the different reading of globulin after 30 and 60 days treatment.

FIP Treatment Albumin/Globulin Readings
Albumin/Globulin readings 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.


FIP Treatment of cat's weight
Weight of cats 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

One cat owner ceased communication and progress reports, and another cat (COT034) passed away during the second 30 days of treatment. The cat was left in a clinic due to the owner's business trip and died the following day. Despite eating and defecating regularly, the cat exhibited neurological symptoms during the treatment. On the 38th day, the owner reported significant improvement, but we suspect that the cat did not absorb adequate amounts of the antiviral drug GS-441524 and was therefore under-dosed throughout the treatment. The owner declined a post-mortem analysis of the cause of death. In retrospect, this cat was not a suitable candidate for oral treatment and should have received at least 30 days of injections before switching to oral capsules for the remainder of the treatment.


4. CONCLUSION

According to the data obtained from our clinical trial, it appears that CURE FIP™ oral capsules are highly effective in treating cats with mild symptoms of feline infectious peritonitis. Within 30 days of treatment, 13 cats fully recovered, while 24 cats fully recovered after 60 days of treatment. Unfortunately, 3 cat owners stopped communicating with us during the treatment, 2 cats went missing, and 1 cat passed away. However, based on the blood test reports and daily progress reports, all cats showed steady progress towards recovery until communication stopped.



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