It’s still a wait-and-see on Canadian clinical stage biotech company Arch Biopartners (Arch Biopartners Stock Quote, Charts, News, Analysts, Financials TSXV:ARCH), according to Raymond James analyst Rahul Sarugaser, who delivered an update on Tuesday where he reiterated a “Market Perform” rating on the stock.
Toronto-based Arch Biopartners announced on Tuesday that it has completed a dose-escalation study showing that up to 20 mg per day of the LSALT peptide — a 4x increase over the 5 mg dose used in its Phase 2 trial in hospitalized COVID-19 patients — is safe.
Arch said it now will use the new maximum dose in designing a Phase 2 trial targeting cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is Arch’s lead drug candidate for the treatment of inflammation of the lungs, liver and kidneys.
“The new safety data will be included in an Investigational New Drug Application to the U.S. FDA, to be submitted in relation to the CS-AKI trial in due course,” Arch Biopartners said in a press release.
Sarugaser said the news represents an incremental positive for Arch, as the company broadens its options for the CS-AKI trial, giving that trial a potentially broader window of efficacy.
“This said, we reiterate that we remain cautiously optimistic as we await publication of ARCH’s Ph 2 COVID data (est. 1H23)—which, in our view, will be seminal in determining the likely success (or failure) of ARCH’s anticipated Phase 2 trial in AKI—before making any further prognostications on its predictiveness, so maintain our Market Perform rating,” Sarugaser wrote.
Sarugaser also commented on Arch’s announcement that it has completed the production of about 10,000 LSALT peptide product vials at a 5 mg dose, which are now undergoing quality control. The analyst said the production gives Arch all the drug product it needs to complete its Phase 2 trial in AKI plus any other pipeline trials it may be planning.
Sarugaser maintained a one-year target price of $3.50 on Arch Biopartners, which represented at press time a projected return of 62.8 per cent.