Biofrontera Inc. (BFRI:NASDAQ) announced that three tubes of its Ameluz topical gel, in combination with photodynamic therapy, exhibited a positive safety profile when used to treat facial and scalp actinic keratosis, reported ROTH Capital Partners analyst Dr. Jonathan Aschoff in an Aug. 28 research note. The currently approved dose in the States is one tube.
278% return implied
ROTH reiterated its price target on the Massachusetts-based biopharma of $33 per share. Biofrontera's current share price, in comparison, is about $8.72. Given these figures, the projected potential return for investors is material, at 278%.
Biofrontera is a Buy.
New safety data
Aschoff summarized the findings of the recent Phase 1 clinical trial, in which treatment, using three tubes of Ameluz and photodynamic therapy administered via the company's RhodoLED XL lamp, was evaluated for safety and tolerability.
None of the patients reported any serious adverse events or quit the study because of a treatment-associated adverse event.
The adverse events that did occur were expected due to "the therapeutic principle of photodynamic therapy," wrote Aschoff, and were consistent with those linked to the use of one tube of Ameluz in the same indication. Typically, effects that occurred resolved in one to four days after photodynamic therapy but sometimes lasted one to two weeks.
Overall, patients tolerated treatment well.
Pursuit of label expansion
Biofrontera intends to submit these safety data to the U.S. Food and Drug Administration, in Q4/23, to support expansion of its Ameluz label to include use of up to three tubes per treatment, Aschoff reported.
An expansion, the analyst added, would make "Ameluz more competitive, given the ability to treat more surface area per treatment." Therefore, treatment could be administered in fewer office visits, another positive.
Superior efficacy
Already, Ameluz differentiates itself from competitors, Aschoff pointed out, because it is the only treatment of this type in which the drug is administered broadly over a field versus being applied to individual keratoses.
"The treatment is particularly effective because the procedure treats both visible actinic keratosis lesions as well as invisible lesions that lie within the field defined by the visible lesions," explained Aschoff. "This application difference is part of why Ameluz's efficacy is unmatched by competitors."
More data early next year
In other news, Biofrontera has advanced the Phase 3 trial assessing Ameluz plus photodynamic therapy in basal cell carcinoma to the point where the last of the 187 enrolled patients will complete final assessment in Q1/24, Aschoff noted.
Data readout should happen soon afterward.
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