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– Preliminary results of second cohort in the first-in-human Phase 1a allow Company to proceed to 32 mg/kg dose of WP1122 in third cohort toward establishing maximum tolerated dose (MTD) –
– Multiple ascending dose (MAD) cohort to commence after completion of at least 3 successful SAD dosing cohorts –
HOUSTON, July 8, 2022 /PRNewswire/ — Moleculin Biotech, Inc.(NASDAQ:MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today reported preliminary results from the second cohort of the Company’s first-in-human Phase 1a study of WP1122. This cohort consisted of 8 subjects dosed with 16 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK). Based on the overall results in Cohort 2, the Company deemed the cohort dose safe and well-tolerated and began its SAD Cohort 3 with a dose escalation to 32 mg/kg.
The Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD is investigating the effects of WP1122 administered as an oral solution in healthy human volunteers. It is the first step in a planned investigation of WP1122 for the treatment of COVID-19. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has successfully completed at least 3 dosing cohorts. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development is expected to be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately … …
Full story available on Benzinga.com
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