Citius Pharmaceuticals Inc (CTXR:NASDAQ) has seen the first patient enrolled in its Phase 2b clinical trial of Halo-Lido as a hemorrhoids treatment, reported DawsonJames Securities analyst Jason Kolbert in an April 26 research note.
DawsonJames rates Citius Buy.
Also, Citius offers investors significant potential return from its current share price of $1.11 to the per-share target price of $10 assigned to it by DawsonJames.
As for the biopharma's Phase 2b study, in which multiple centers will participate, five cohorts of 60 adult patients each will be enrolled, for 600 in all, Kolbert explained. Participants will have a clinical diagnosis of symptomatic grade II or III hemorrhoids.
Citius' Halo-Lido, noted Kolbert, is a combination of lidocaine and the corticosteroid halobetasol, both of which are used to treat hemorrhoid symptoms.
Kolbert highlighted that the demand for a drug like Halo-Lido is substantial due to several factors. One is the current paucity of U.S. Food and Drug Administration-approved, prescription hemorrhoid treatments. Halo-Lido would be the first, if the federal agency were to greenlight it.
Two, the hemorrhoid therapies that do exist only provide temporarily relief and lack efficacy data. They are primarily over the counter (OTC) remedies, such as Preparation H and stool softeners, but also include a few prescription products, like analgesics and topical steroids.
"Despite these shortcomings and the lack of reimbursement, there is significant patient and physician demand for these products," Kolbert wrote. He added that hemorrhoid sufferers buy 22 million OTC and 4 million prescription products for the condition each year.
Finally, hemorrhoids are prevalent in the U.S. with about 12 million people having them. This group constitutes an existing market for an effective prescription hemorrhoids treatment.
Kolbert also pointed out that hemorrhoid patients typically need repeat courses of therapy, as many as three to five per year. This is due to a high rate of recurrence because the available treatments are not curative.
"Therefore, we believe it is more appropriate to view the hemorrhoids market as a chronic therapy market rather than a single-use therapy market," wrote Kolbert.
DawsonJames rates Citius Buy.
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Disclosures for Dawson James Securities, Citius Pharmaceuticals, April 26, 2022
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