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Hepion Pharmaceuticals, Inc (HEPA)

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Last Post: 11/18/2020 12:36:55 PM - Followers: 65 - Board type: Free - Posts Today: 0

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
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

     

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

  •  

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 acyclovirvalacyclovir, 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
     




 







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HEPA News: Current Report Filing (8-k) 11/20/2020 04:06:02 PM
HEPA News: Securities Registration Statement (s-1/a) 11/18/2020 05:29:25 PM
HEPA News: Current Report Filing (8-k) 11/18/2020 08:30:27 AM
HEPA News: Current Report Filing (8-k) 11/17/2020 04:54:26 PM
HEPA News: Quarterly Report (10-q) 11/16/2020 05:04:00 PM
PostSubject
#903  Sticky Note $hepa $10 with news Taurus69 09/18/19 01:00:26 AM
#1201   What’s the opinion on the market value being Prudent1 11/18/20 12:36:55 PM
#1200   $hepa $2.89 ^ 0.07 (2.48%) Taurus69 11/17/20 06:37:45 PM
#1199   $hepa $2.87 ^ 0.18 (6.69%) Taurus69 11/09/20 04:16:42 PM
#1198   $hepa $3.5 ^ 0.07 (2.04%) Taurus69 10/25/20 06:40:07 PM
#1197   $HEPA: Going to $20 before end of YEAR makinezmoney 10/23/20 03:04:20 PM
#1196   $hepa $3.13 ^ 0.13 (4.33%) Taurus69 10/03/20 12:34:57 PM
#1195   $hepa $3.08 ^ 0.18 (6.21%) Taurus69 09/27/20 02:57:24 PM
#1194   Awesome info here about the $HEPA warrants. $CTRVW Moose Cat 09/18/20 06:10:20 PM
#1193   All boards for rights and warrants are deleted Moose Cat 09/18/20 06:05:28 PM
#1192   $hepa $3.57 v -0.05 (-1.38%) Taurus69 08/25/20 05:43:57 PM
#1191   $hepa $4.21 ^ 0.01 (0.24%) Taurus69 07/30/20 05:02:44 PM
#1190   $hepa $4.2 ^ 0.17 (4.22%) Taurus69 07/29/20 09:49:46 PM
#1189   As predicted by the vertical green band. I swingingRichard 07/27/20 11:44:14 PM
#1188   $hepa $3.34 ? 0.0 (0.00%) Taurus69 07/16/20 05:39:59 PM
#1187   CTRVW is the warrant for HEPA. Exercise hh718 07/13/20 02:48:58 PM
#1186   Why dont you guys take your convo over The Deevs 07/13/20 02:22:12 PM
#1185   Thanks I got a few. Luckypennyman 07/11/20 05:20:41 PM
#1184   0.13 it shows. NewYorker567 07/10/20 04:38:20 PM
#1183   Heya New Yorker and Lucky Penny Man, finally hh718 07/10/20 01:17:24 PM
#1182   No ask price for ctrvw ? Luckypennyman 07/10/20 09:26:19 AM
#1181   Me too! Showed some strength on a slow The Deevs 07/09/20 03:02:11 PM
#1180   Warrants CTRVW were .28 earlier. Get them now NewYorker567 07/09/20 11:20:42 AM
#1179   I AM HOLDING ON TO MY SHARES $$$$HEPA$$$$ JOHNNY-VEGAS 07/08/20 09:41:14 AM
#1178   * * $HEPA Video Chart 07-07-2020 * * ClayTrader 07/07/20 04:08:35 PM
#1177   In at 3.98. Thought maybe I could get The Deevs 07/07/20 01:19:54 PM
#1176   CHART LOOKING BEAUTIFUL. JOHNNY-VEGAS 07/07/20 09:59:51 AM
#1175   I was in the wrong board. But hey NewYorker567 07/06/20 10:31:10 PM
#1174   $hepa $2.84 v -0.03 (-1.05%) Taurus69 07/05/20 09:13:40 PM
#1173   Apologize for so many details. NewYorker567 07/01/20 12:54:55 PM
#1172   Market being groomed for a very strong week NewYorker567 07/01/20 12:54:10 PM
#1171   Decent drop earlier. One more drop now? And NewYorker567 07/01/20 12:39:12 PM
#1170   Warrants $2 NewYorker567 07/01/20 11:03:36 AM
#1169   * * $HEPA Video Chart 06-23-2020 * * ClayTrader 06/23/20 05:55:49 PM
#1168   I AM VERY HAPPY IN HERE $$$HEPA$$$ JOHNNY-VEGAS 06/18/20 12:37:07 PM
#1167   $hepa $2.2 ^ 0.0116 (0.53%) Taurus69 06/16/20 06:28:15 PM
#1166   nice little rebound here. JOHNNY-VEGAS 06/04/20 11:21:05 PM
#1165   $hepa $1.95 ^ 0.03 (1.56%) Taurus69 06/02/20 11:12:46 PM
#1164   $hepa $1.98 Taurus69 05/24/20 05:33:22 PM
#1163   Watch for $2.20 break ! stock1ace1 05/22/20 08:19:56 AM
#1162   $hepa $1.64 Taurus69 05/14/20 11:27:37 PM
#1161   $$HEPA$$ JOHNNY-VEGAS 05/06/20 05:22:43 PM
#1160   $hepa $1.69 Taurus69 05/03/20 05:50:25 PM
#1159   $hepa $1.35 Taurus69 04/25/20 03:16:09 AM
#1158   $hepa $1.48 Taurus69 04/20/20 04:44:35 AM
#1157   $hepa $1.56 Taurus69 04/14/20 04:04:48 AM
#1156   $hepa $1.57 Taurus69 04/04/20 05:49:09 PM
#1155   $hepa $1.63 Taurus69 04/03/20 02:18:25 AM
#1154   $hepa $1.86 Taurus69 03/28/20 04:51:27 PM
#1153   Sounds promising. If this drug helps cv we bigrun 03/21/20 05:55:16 PM
#1152   ROTH'S ARTICLE FOR CRV 431'SEVERE COVID-19 CASES.. JOHNNY-VEGAS 03/21/20 01:39:57 PM
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