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.
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