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Interim Results From Phase 2b Trial Are ‘Encouraging’

Source: Dr. Elemer Piros   09/30/2022

Data show the biotech’s compound had a positive effect on several noninvasive measures, noted a ROTH…



Source: Dr. Elemer Piros   09/30/2022

Data show the biotech's compound had a positive effect on several noninvasive measures, noted a ROTH Capital Partners report.

Interim results from the EMMPACT Phase 2b trial of Axcella Therapeutics' (AXLA:NASDAQ) AXA1125 in nonalcoholic steatohepatitis (NASH) are "encouraging," ROTH Capital Partners analyst Dr. Elemer Piros reported in a September 29, 2022 research note. AXA1125 is an oral, endogenous metabolic modulator comprised of six amino acids and derivatives.

Given it is currently trading at $1.73 per share, Axcella offers investors significant potential return.




After the recent release of these data, ROTH reiterated its Buy rating and $19 per share price target on the Massachusetts-based biotech.

Given it is currently trading at $1.73 per share, Axcella offers investors significant potential return.

Positive Changes with Both Doses


Piros reviewed the interim EMMPACT study results for three noninvasive measures obtained at week 12 (82 patients) and week 24 (58 patients). Two different doses of AXA1125 and a placebo are being evaluated.

With respect to liver stiffness, as measured by FibroScan at 24 weeks, results were statistically significant for the high dose group (p=0.0096). These patients experienced a 4.07 kilopascal (4.07 kPa) reduction in liver stiffness. In the low dose group, the reduction in liver stiffness was 2.01 kPa, and in the placebo group, it was insignificant at -0.13 kPa.

Regarding alanine aminotransferase or ALT levels at weeks 12 and 24, results were statistically significant for the high and low-dose cohorts (p<0.05 for both). With the high dose, ALT levels dropped 36.3%, and with the low dose, 28.61%.

In terms of liver fat content, as calculated via MRI-PDFF, it, too, was lower. At 12 weeks, it lessened by 21.24% in the high-dose cohort and 18.98% in the low-dose cohort (p<0.05 for both). At 24 weeks, "only an improving trend was seen," Piros relayed.

Though previous AXA1125 results were better among diabetics, in this study, no significant differences between diabetics and non-diabetics were noted.

For comparison's sake, Piros provided data on Akero Therapeutics' fusion protein, efruxifermin, 50 milligrams, obtained in a different study. With this dose, at 24 weeks, liver stiffness, ALT levels, and liver fat content were all reduced, by 4.3 kPa, 47%, and 64%, respectively.

"We note that efruxifermin is a subcutaneously injected protein, while AXA1125 is an orally administered agent," wrote Piros.

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Disclosures For ROTH Capital Partners, Axcella Therapeutics September 29, 2022

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.

Disclosures: ROTH makes a market in shares of Axcella Therapeutics and as such, buys and sells from customers on a principal basis. Shares of Axcella Therapeutics may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

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. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request.

This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH.

( Companies Mentioned: AXLA:NASDAQ), )

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