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PIPELINE OF DRUG CANDIDATES

ContraVir is developing drug candidates for expanding market segments with high unmet need.

DISEASE AREAS

CHRONIC HEPATITIS B

Hepatitis B is an infectious disease caused by the hepatitis B virus (“HBV”). Individuals who develop chronic HBV are at much greater risk for liver disease later on in their life. The greatest risk posed is potential cirrhosis of the liver and hepatocellular carcinoma. The U.S. is the largest individual market and is growing rapidly.

HERPES ZOSTER (SHINGLES

Herpes zoster, also commonly known as shingles, is a neurological disorder caused by the reactivation of varicella zoster virus, the same virus that causes chicken pox. Based on recent research and publications, we estimate that there are over four million cases of shingles in the U.S., Europe and Japan each year.

PIPELINE EXPANSION

ContraVir is dedicated to serving patients and healthcare professionals by developing clinically-differentiated therapeutic products that address high-need market segments. ContraVir brings its financing, product development, and commercialization expertise to create long-term value for partners with unique clinical candidates.

TXL™ Phase 1

A Multiple Dose Study of the Safety, Tolerability and PK of TXL™ in Healthy Subjects

OVERVIEW

Title: A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of TXL™ in Healthy Subjects

Condition: Infectious Disease

Interventions: TXL™; Placebo

OBJECTIVES

Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at increasing dose levels

Secondary Objective: To evaluate the pharmacokinetics of multiple doses of TXL™ at increasing dose levels, in a fasted state; to evaluate the pharmacokinetics of a single dose of TXL™ 50 mg in a fed state

ELIGIBILITY

Age: 18 years to 55 years

Gender: Both

Healthy Volunteers: Accepted

Inclusion Criteria:

Capable of giving written informed consent
Capable of completing study requirements

Exclusion Criteria:

Positive result for HIV, HBV, or HCV
History or medical condition which could impact patient safety
Current or past abuse of alcohol or illicit drugs
Participation in another clinical trial within the past 30 days

Hepatitis B

ContraVir is developing Tenofovir Exalidex (TXL™) for Hepatitis B in Phase 2 clinical studies. TXL™ is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent of tenofovir, marketed by Gilead as Viread®.

TXL™’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. TXL™ has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability, and drug distribution profile.

ContraVir believes a potentially best-in-class antiviral like TXL™ can become the cornerstone of a curative combination therapy for hepatitis B. The combination would include multiple drugs that inhibit different points in the viral life cycle, such as ContraVir’s cyclosporine A-derived antiviral TXL™, which is currently in preclinical development.

Potential Advantages of TXL™ over Tenofovir

Increased efficacy by boosting bioavailability
Takes advantage of natural lipid uptake mechanisms
Decreased renal toxicity by reduced circulating TFV
97-fold more active against HBV in vitro

TXL™ Phase 2

A Multiple Ascending Dose Proof of Concept Study

OVERVIEW

Title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TXL™ in HBV-infected Subjects

Condition: Infectious Disease

Interventions: TXL™; TDF (Viread)

OBJECTIVES

Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at multiple ascending dose levels; to evaluate the antiviral activity of TXL™ versus Tenofovir disproxil fumarate (TDF; Viread)

Secondary Objective: To evaluate the pharmacokinetics (PK) of multiple doses of TXL™ at multiple dose levels in a fasted state

ELIGIBILITY

Age: 18 years to 65 years

Gender: Both

Healthy Volunteers: Not accepted

Inclusion Criteria:

Capable of giving written informed consent
Capable of completing study requirements
Chronic hepatitis B positive
HBV treatment naïve

Exclusion Criteria:

Positive result for HCV (hepatitis C virus), HDV (hepatitis D virus) or HIV (human immunodeficiency virus)
History or medical condition that could impact patient safety
Current or past abuse of alcohol or illicit drugs
Abnormal laboratory value or ECG
Pregnant or breastfeeding
Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis
Systemic immunosuppression
Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug

CRV431

Hepatitis B

ContraVir is developing CRV431 for treating hepatitis B and is currently preparing to enter IND-enabling studies based on strong preclinical data. CRV431 belongs to a known drug class of cyclophilin inhibitors derived from cyclosporine A, and was designed specifically to optimize potency and selectivity against HBV.

CRV431 works by disrupting certain host mechanisms that are “hijacked” by HBV as it replicates within liver cells. It is expected to be effective against all HBV genotypes due to the fact that it interrupts more than one point in the viral life cycle that are common in all HBV sub-types.

Potential Advantages of CRV431

Best-in-class potency and selective index against HBV
Interrupts HBV at multiple points, limiting replication and potential resistance
Blocks HBV entry into liver cells and suppresses HBsAg and HBeAg in vitro
Reduces HBV DNA without toxicity; prevents liver fibrosis in vivo

Valnivudine™ Phase 3

OVERVIEW

Title: A Multicenter, Randomized, Double-Blind, Parallel Group, Comparative Study of Valnivudine™ vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster-Associated Pain

Condition: Shingles/Herpes Zoster

Interventions: Valnivudine™; Valacyclovir

Learn about the Valnivudine™ Clinical Trial at GotShingles.com >>

OBJECTIVES

Primary Objective: To evaluate the incidence of post-herpetic neuralgia (PHN) following treatment with 2 dose regimens of Valnivudine™ compared to Valacyclovir

Secondary Objectives: To evaluate the effect on pain associated with acute herpes zoster (AHZ) of 2 dose regimens of Valnivudine™ compared to Valacyclovir; to describe the effect on lesion formation and healing of 2 dose regimens of Valnivudine™ compared to Valacyclovir

Safety: To evaluate the safety profile of 2 dosing regimens of Valnivudine™ as compared to Valacyclovir

Pharmacokinetic: To evaluate the pharmacokinetic (PK) profile of the active metabolite (CF-1743) of Valnivudine™ after 7 days of dosing at 400 mg once-daily (QD) compared with 400 mg twice-daily (BID)

Methodology: A multicenter, randomized, double-blind, parallel-group, active-controlled comparative study of the safety and efficacy of 2 dosing regimens of Valnivudine™ versus Valacyclovir administered for 7 days in subjects with uncomplicated AHZ. Subjects diagnosed with uncomplicated AHZ within 120 hours of lesion appearance and Worst Pain in the Last 24 hours of ≥4 (0-10 numerical rating scale) at Visit 1/Day 1, will be randomized (1:1:1) to one of 3 treatment groups and will begin study treatment at Visit 1/Day 1 to either:

Valnivudine™ 400 mg QD
Valnivudine™ 400 mg BID (total daily dose of 800 mg)
Valacyclovir 1000 mg 3 times a day for a total daily dose of 3000 mg

Efficacy assessments for lesion status and AHZ pain are captured until Day 120.

Post-herpetic Neuralgia (PHN)

We are developing Valnivudine™ as a fast-acting, low-dose, once-daily, oral antiviral therapy for the treatment of herpes zoster, or shingles, an infection caused by the reactivation of the varicella zoster (chicken pox) virus. In addition to its potent antiviral activity, Valnivudine™ has demonstrated an ability to reduce the incidence and severity of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN.

We are currently conducting a pivotal Phase 3 trial that will compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.

Shingles

Driven primarily by the aging adult population, the rate of shingles is increasing steadily. Recent research estimates there are more than four million cases of singles each year in the major markets of the U.S., Europe, and Japan, of which more than half occur in the U.S. Further, approximately two-thirds of shingles patients suffer from pain for 30 days or longer. Learn more about shingles and shingles pain >>

The pain associated with an episode of shingles is attributed to both the damage caused to the affected nerves by the replication of varicella zoster virus and the inflammatory response associated with the infection.

For many patients, shingles-associated pain does not resolve when the lesions heal and the inflammation subsides, but, rather, continues for months, or possibly years. Shingles-associated pain, or PHN, is the most common and clinically relevant complication of shingles.

Post-herpetic Neuralgia (PHN)

Mild to excruciating pain long after shingles rash resolves
>65-70% of shingles patients suffer from PHN for 30 days or more; can last for 2-3 years
Disrupts sleep, mood, work, and activities of daily living

Opportunity

Rapid onset of action for quick pain relief
Higher potency vs. approved agents against herpes zoster
Efficacy profile superior to valacyclovir
Potential for QD dosing vs. 3-5x daily for valacyclovir
No dose adjustments needed for patients with renal insufficiency

Clinical Data

Phase 1 and 2 trials of Valnivudine™ were successfully completed. We are currently conducting a pivotal Phase 3 trial in patients with shingles to further explore Valnivudine’s™ potential ability to reduce shingles pain.

Demonstrated Safety and Efficacy

>350 patients treated with Valnivudine™
Clinically meaningful reduction in PHN occurrence versus valacyclovir
Meaningful reduction in time to resolution of clinically significant pain
8-10% fewer patients required narcotics for pain control
Safety similar to other antivirals

Phase 3 Study

ContraVir’s pivotal Phase 3 study seeks to compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.

Phase 3 Study Design

Multi-center, randomized, double-blind, parallel-group, comparative study (Valnivudine™ vs. valacyclovir)
Up to 200 centers (U.S. only)
Three-arm study: Valnivudine™ 400mg QD, Valnivudine™ 400mg BID, Valacyclovir 1000mg TID
985 patients estimated with 275 patients per arm
Patients aged 30 years and older
Seven day treatment period; follow up through day 120

Scientific Research

Pharmacokinetic data from completed Phase 1 and 2 clinical trials suggest that Valnivudine™ has the potential to demonstrate antiviral activity when dosed orally once-a-day at significantly lower blood levels than acyclovir, valacyclovir, and famciclovir, the FDA-approved drugs used for the treatment of shingles.

INTELLECTUAL PROPERTY

TXL™ composition of matter to 2031
CRV431 composition of matter to 2031
Valnivudine™ composition of matter to 2027

CTRV
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CTRV Detailed Quote

CTRV News: Statement of Changes in Beneficial Ownership (4)	07/21/2017 04:02:36 PM
CTRV News: Statement of Changes in Beneficial Ownership (4)	07/07/2017 05:02:52 PM
CTRV News: Statement of Changes in Beneficial Ownership (4)	07/07/2017 05:02:52 PM
CTRV News: Statement of Changes in Beneficial Ownership (4)	07/07/2017 05:02:25 PM
CTRV News: Statement of Changes in Beneficial Ownership (4)	07/07/2017 05:02:25 PM

ContraVir Pharmaceutcals (CTRV)

PIPELINE OF DRUG CANDIDATES

DISEASE AREAS

CHRONIC HEPATITIS B

HERPES ZOSTER (SHINGLES

PIPELINE EXPANSION

A Multiple Dose Study of the Safety, Tolerability and PK of TXL™ in Healthy Subjects

OBJECTIVES

ELIGIBILITY

Potential Advantages of TXL™ over Tenofovir

TXL™ Phase 2

A Multiple Ascending Dose Proof of Concept Study

OVERVIEW

OBJECTIVES

ELIGIBILITY

CRV431

Potential Advantages of CRV431

Valnivudine™ Phase 3

OVERVIEW

OBJECTIVES

Shingles

Post-herpetic Neuralgia (PHN)

Opportunity

Clinical Data

Demonstrated Safety and Efficacy

Phase 3 Study

Phase 3 Study Design

Scientific Research

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