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Biopharma Starts 'Key Catalyst Period,' H2/19, with Clinical Trial in New Indication
Research Report

Source:

A study description and expected data readouts this year are provided in a ROTH Capital Partners report.

In a July 8 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that Enanta Pharmaceuticals Inc. (ENTA:NASDAQ) kicked off Q2/19 by launching the Phase 1a/b study of its core assembly inhibitor EDP-514 in hepatitis B.

Rahimi reviewed the study purpose and design. This first part of the trial is to evaluate safety and tolerability of once-daily EDP-514 in 98 healthy subjects. This will be carried out in two phases. In the first, a single administration of EDP-514 or placebo will be tested at six different increasing doses for eight days. Also, a two-part cohort will assess the potential effect of taking EDP-514 with and without food. In the second phase, participants will receive a multiple ascending dose or placebo for 14 days.

The study will also measure the pharmacokinetics of the inhibitor, "which we believe is important for confirming EDP-514's compelling preclinical profile," Rahimi noted. "Confirmation of good pharmacokinetics will strengthen the case for EDP-514 being able to hit the viral target as hard as possible."

After the trial component in which EDP-514 is evaluated in healthy people, expected to be completed in December 2019, Enanta will then test the inhibitor in hepatitis B patients who have nucleos(t)ide analogue suppression.

Also expected from the U.S. biopharma in H2/19, specifically Q3/19, is a topline data readout for the FXR agonist EDP-305 in nonalcoholic steatohepatitis (NASH), "an important but underappreciated NASH catalyst," Rahimi indicated.

Results from that trial—ARGON-1, Phase 2, 125 patients, 12 weeks and placebo controlled—could be announced at the end of this month. "We see H2/19 as a key catalyst period for Enanta as it moves beyond hepatitis C," commented Rahimi.

ROTH has a Buy rating and a $130 per share price target on Enanta, whose stock is currently trading at around $88 per share.

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Disclosures from ROTH Capital Partners, Enanta Pharmaceuticals Ltd., Flash Note, July 8, 2019

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of Enanta Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.




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