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Azitra’s ATR12-351 shows safety in Phase 1b Netherton syndrome trial

Azitra (AZTR) announced “encouraging” safety data from the initial clinical trial of its live biotherapeutic candidate, ATR12-351, targeting Netherton syndrome. Netherton syndrome is a rare, autosomal recessive disease that affects the skin, hair, and immune system, often with severe consequences including chronic skin inflammation and dehydration throughout life. The disease affects approximately one in every 200,000 persons, but its prevalence may be underestimated due to misdiagnosis. There is no known cure for Netherton syndrome, and treatment options are limited. The primary objective of the Phase 1b trial is to assess the safety and tolerability of topically applied ATR12-351. The trial is halfway enrolled, as six patients have been dosed with ATR12-351. There have been no reports of severe or serious adverse events in the ongoing clinical trial. Application site reactions have been transient and self-resolving and included mild to moderate localized itch, redness, and a burning sensation with application. Such reactions have been observed bilaterally, suggesting this is not a drug effect. Azitra will discuss the Phase 1b trial at the BIO International Convention in Boston, June 17.

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