In a Dec. 19 announcement, ContraVir Pharmaceuticals Inc. (CTRV:NASDAQ) noted that tenofovir exalidex (TXL), its "potent prodrug analog of tenofovir, exhibited increased antiviral activity at the highest planned dose of 100 mg in the ongoing Phase 2a multiple ascending-dose clinical trial." The drug is being evaluated in a "head-to-head trial" with tenofovir disoproxil fumarate (TDF; Viread), which is marketed by Gilead Sciences Inc. (GILD:NASDAQ).
"ContraVir plans to begin evaluating TXL at 150 mg per day dosing and potentially higher dosing based on TXL's continued strong performance, to date, and following recent clearance by the independent data safety monitoring board (DSMB)," the company stated.
Kumaraguru Raja of NOBLE Life Science Partners, in a research note published Dec. 19, noted "favorable safety, tolerability and pharmacokinetic profile at lower doses supports dose escalation above [the] 100 mg dose. It needs to be seen if the favorable safety and tolerability profile is maintained at the higher doses and leads to further increase in anti-viral activity."
In addition to TXL's being "designed to alleviate poor bioavailability and dose limiting toxicity associated with currently marketed tenofovir (Viread)," Raja stated there is a "significant unmet market need in HBV patients."
In another research report published Dec. 19, Gabrielle Zhou of Maxim Group noted, "The observed antiviral activity of TXL is comparable to TDF (Viread), but at a significantly lower dose: 1/12th the dose of TDF (25mg TXL versus standard 300mg TDF)." Because the ContraVir compound resulted in "lower systemic tenofovir exposure," Zhou stated that side effects were reduced and that TXL offered "a better safety profile."
Zhou wrote that because TXL has "already demonstrated strong anti-viral activity at a low dose of 25 mg and continues to show increased antiviral activity at the dose of 100 mg, this begs the question, what if we push the dose? Could we impact (cccDNA) and effect a cure? If that were true, TXL becomes a game changer in the world of HBV and transforms the lives of patients (and the company)."
In a research report from October, Laidlaw & Company's Jim Molloy was "encouraged by the real potential of CMX157 [TXL] becoming a potent backbone of combination therapy for HBV."
"TXL has shown an excellent safety profile, and we are encouraged that as we go to higher doses above 100 mg we may see even greater antiviral activity with a continued excellent safety profile. We believe demonstrating this unique profile for TXL may open many doors in terms of developing new combination therapies for HBV that have curative potential." said ContraVir's CEO, James Sapirstein, in the company's Dec. 19 press release.
In addition to TXL for HBV, ContraVir is also developing CRV431, which it calls "a next-generation cyclophilin inhibitor with a unique structure that increases its potency and selective index against HBV." Valnivudine (formerly FV-100) is currently in Phase 3 for treatment of shingles.
Want to read more Life Sciences Report articles like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see recent articles and interviews with industry analysts and commentators, visit our Streetwise Interviews page.
1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She owns, or members of her immediate household or family own, shares of the following companies mentioned in this article: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
2) The following companies mentioned are sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific analysts and not of Streetwise Reports or its officers.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their families are prohibited from making purchases and/or sales of those securities in the open market or otherwise during the up-to-four-week interval from the time of the interview or article until after it publishes.
Disclosures from NOBLE Life Science Partners, ContraVir, Equity Research, Dec. 19. 2015
The following disclosures relate to relationships between Noble and the company (the "Company") covered by the Noble Research Division and referred to in this research report.
Noble has provided capital markets advisory services in the last 12 months. The Company has attended Noble investor conference(s) in the last 12 months. Noble has arranged non-deal roadshow(s) with investors in the last 12 months.
Noble has received compensation for non-investment banking services in the past 12 months. Noble expects to receive compensation for noninvestment banking services in the next 3 months.
Noble intends to seek compensation for investment banking services and non-investment banking services (securities and non-securities related) within the next 3 months.
Noble is a market maker in the Company.
RESEARCH ANALYST CERTIFICATION
Independence Of View
All views expressed in this report accurately reflect my personal views about the subject securities or issuers.
Receipt of Compensation
No part of my compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public appearance and/or research report.
Ownership and Material Conflicts of Interest
Neither I nor anybody in my household has a financial interest in the securities of the subject company or any other company mentioned in this report.
Disclosures from Maxim Group, ContraVir Pharmaceuticals Inc., Dec. 19, 2016
I, Gabrielle Zhou, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
I, Jason Kolbert, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm’s total revenues, a portion of which is generated by investment banking activities.
Maxim Group makes a market in ContraVir Pharmaceuticals, Inc.
Maxim Group expects to receive or intends to seek compensation for investment banking services from ContraVir Pharmaceuticals, Inc. in the next 3 months.
Disclosures from Laidlaw & Company, ContraVir Pharmaceuticals, Oct. 14, 2016
The analyst responsible for the content of this report hereby certifies that the views expressed regarding the company or companies and their securities accurately represent his personal views and that no direct or indirect compensation is to be received by the analyst for any specific recommendation or views contained in this report. Neither the author of this report nor any member of his immediate family or household maintains a position in the securities mentioned in this report.
Laidlaw & Co. has provided any investment banking services for the company (ies) mentioned in this report over the last 12 months, and intends to seek investment banking services for the company (ies) mentioned in this report over the next three months.