FIP CLINICAL TRIAL REPORT (Part I) : Post 30 days oral treatment report.

1. OBJECTIVES

The goal of this clinical trial report is to examine the safety and efficacy of GS441524 based oral capsules by CURE FIP™ 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.

2. INTRODUCTION

GS-441524 nucleoside analogue was established as an effective antiviral treatment for feline infectious peritonitis several years ago by a team of researchers in the University of California, Davis. Since then tens of thousands of cats have been saved globally using the injection form of GS-441524. However, there are some inherent shortcomings associated with injections including severe skin irritations, aversion to injections and difficulty to administer injections towards the latter part of the treatment as cats acquires the strength to struggle. The creation of an oral form of feline infectious peritonitis treatment attempts to overcome these inherent shortcomings and provides veterinary professionals and cat owners a more convenient way to deliver GS-441524 to feline infectious peritonitis infected cats on a daily basis.

The goals of developing oral GS-441524 capsules are:

1. To develop an easy to administer oral treatment that cat owners can use without the assistance of a veterinary professional.

2. To achieve similar therapeutic performance as GS-441524 injections.

3. To reduce the likelihood of relapses traditionally associated with oral GS-441524 treatments from other brands.

43 FIP 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 a few 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 trial study administered the oral capsules using 3 possible 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.

3. METHODOLOGY

The trial began with 43 FIPV-infected cats ranging in age from 5 to 96 months. All the cats in the trial were diagnosed as having one of two forms of FIP: non-effusive (dry), effusive (wet), with 5 participants exhibiting ocular or neurological symptoms. These participants are divided into two phases of oral treatment. The duration of each phase is 30 days. This report will conclude the findings of all 43 cats after their completion of the first 30 days of oral treatment. There are 13 cats that showed no clinical signs of FIP after completing 30 days of our oral treatment. These Cats had their blood tests taken and were put on observation after blood tests results showed that the parameters are within normal ranges. We will first focus on the data of 13 cats, then on the 25 cats that still showed clinical symptoms of FIP after 30 days of treatment, and continued on to another 30 days of treatment. A report of the second 30 days phase of the trial will be updated once they have completed 60 days of oral treatment, and their blood test reports are completed. Several cats that participated in our study were part time outdoor cats. Of these cats, 2 of the 43 cats recovered sufficiently within the 30 days of treatment to warrant return to normal outdoor exposures. Their owners reported that they went missing and never returned. We received daily updates from their owner until the date of their disappearance. Their information is also presented in this report, but will be excluding blood test reports after the first.

Table 1 classifies the breeds of the participating cats. The treatment was given at various dosages according to the weight of the cats. All cats were required to complete a pre-treatment blood test. Cats that were unable to feed by themselves were required to complete 2 weeks of GS-441524 injections or until they were able to eat and defecate normally before entering into the clinical study. All cats instructed to complete a blood test after 30 days of treatment to measure changes in key blood test markers.

Bodyweight was chosen as the only determining factor for the oral treatment dosage. Type of FIP and symptoms were non-determining factors for the purpose of this clinical trial.

Code	Breed	Age	Type of FIP
COT001	Domestic Shorthair	2	Wet
COT002	Domestic Shorthair	0.3	Wet
COT003	Domestic Shorthair	0.75	Dry
COT004	Domestic Shorthair	0.75	Wet
COT005	Domestic Shorthair	18	Wet
​COT006	Domestic Shorthair	8	Dry
COT007	Domestic Longhair	1	Dry
​COT008	Tabby	6	Wet
COT009	​Tabby	1	Dry
COT010	British Shorthair	3	Wet
COT011	Domestic Shorthair	1	Wet
COT012	Domestic Shorthair	0.5	Wet
COT013	Domestic Shorthair	1	Dry
COT014	Munchkin	3	Wet
​COT015	Domestic Longhair	1.5	Neurological
COT016	Domestic Longhair	9	Dry
COT017	Domestic Shorthair	7	Wet
COT018	Domestic Shorthair	1.5	Wet
COT019	British Shorthair	3	Wet
COT020	Domestic Shorthair	3	Wet
COT022	Domestic Shorthair	0.9	Wet
COT023	Domestic Shorthair	5	Dry
COT024	Domestic Longhair	2	Wet
COT025	British Shorthair	2	Dry

COT026	British Shorthair	0.6	Wet
COT027	Domestic Shorthair	2	Wet
COT028	Domestic Shorthair	0.9	Dry
COT029	Domestic Shorthair	10	Wet
COT030	Domestic Shorthair	0.6	Dry
COT031	Siberian