In a June 18 research note, analyst Zegbeh Jallah reported that ROTH Capital Partners increased its price target on Clearside Biomedical Inc. to $15 per share from $9 after the biopharma reported a set of trial data showing early efficacy. ROTH's new target reflects the stock has threebagger potential given its current price is about $4.64 per share.
The safety and efficacy results that Clearside announced, Jallah noted, were from its Phase 1/2a dose escalation study of CLS-AX (axitinib) in pretreated wet age-related macular degeneration (wAMD) patients. Data were specifically for Cohort 1, the group that received 0.03 milligrams of the inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. This was the lowest of the three tested doses, with the others being 0.1 and 0.3 milligrams. Cohort 1 received one dose of CLS-AX one month after receiving Eylea, an anti-VEGF therapy.
Jallah highlighted that this data set showed CLS-AX to be safe and efficacious. Cohort 1 experienced a mean improvement in best corrected visual acuity (BCVA) of +4.7 letters, and this was after they had lost -0.2 letters following the Eylea injection the month before their CLS-AX dose. Further, none of the patients required retreatment earlier than one month after receiving CLS-AX, and two patients went as long as three months without retreatment.
"While we expected clean safety given the low dose, increases in BCVA beyond that achieved with Eylea were a surprise," Jallah wrote. "With this encouraging start, we're adding CLS-AX to our model and increasing our price target."
Jallah pointed out that investors are looking for three months of durability, which 0.03 mg did not achieve in Cohort 1, but its falling short likely was due to the dose being so low, he purported. Preclinical studies support this hypothesis, he indicated. Also, he posited that Clearside likely could achieve longer duration and improved efficacy by keeping CLS-AX out of the vitreous humor and, instead, maintaining high concentrations of it in the retinal pigment epithelium–choroid–sclera (RCS). This compartmentalization would allow for the use of CLS-AX doses even higher than those tested in the study.
"Therefore, we look forward to the update from Cohort 2, expected by year-end," Jallah wrote.
ROTH has a Buy rating on Clearside Biomedical.
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