$AKTX Akari Therapeutics (AKTX) $5 target !!!!!
Last up to bat we have Akari Therapeutics, which develops innovative treatments for autoinflammatory diseases involving the complement (C5) and leukotriene (LTB4) pathways. Given its strong execution and share price of only $2.14, is now the right time to get in on the action?
According to B.Riley FBR’s Mayank Mamtani, the answer is a resounding yes. At the end of May, the company provided an update on the progress of the clinical trials for bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC) and pediatric transplant-induced thrombotic microangiopathy (HSCT-TMA) indications for its lead program, nomacopan. The candidate is also getting attention for its potential as a therapeutic option for COVID-19 patients.
The 5-star analyst thinks the full Phase 2 BP study results, as well as an orphan designation granted by the FDA and EMA, free AKTX up to kick off end-of-Phase 2 meetings with the FDA and EMA in Q3 2020 to discuss the pivotal Phase 3 trial design. These meetings would address important considerations including enrolling severe patients in addition to mild and moderate, increasing treatment duration from 1.5 to 6 months, an option to dose at 30 mg-plus levels and a choice of active versus comparator arms, including possibly combining or sequencing with steroids.
“There were no treatment-related serious AEs, in line with the favorable tolerability profile noted in other indications (e.g., PNH), highlighting further differentiation relative to steroid standard of care,” Mamtani stated.
However, Mamtani doesn’t dispute the fact that the COVID-19 pandemic has delayed site initiation activities for the Phase 3 HSCT-TMA trial to later in 2020 and the enrollment for the Part B placebo-controlled efficacy cohort of the Phase 1/2 study in severe AKC patients has been halted. That said, Mamtani notes “the interim update remains on track for mid-2020 in ~2/3rd of the targeted 16 patients already enrolled in the study.” He added, “The prior open-label data of nomacopan eye drops demonstrated in three severe atopic keratoconjunctivitis (AKC) patients rapid overall improvement in composite clinical scores of symptoms and signs.”
On top of this, preclinical data has found complement (C5) and leukotriene (LTB-4) pathways may play a role in severe lung inflammation and microthrombi and organ damage associated with COVID-19. This creates an opportunity for nomacopan as it has been shown to produce a “profound and broad-acting anti-inflammatory effect.”
To wrap it all up, Mamtani commented, “We believe AKTX has held up well in the volatile macro environment as investors look to take advantage of the depressed stock levels for this late-stage biotech supported by robust clinical data generated in earlier-stage trials, with incremental Phase 1/2 severe AKC placebo-controlled data anticipated in mid-2020.”
Everything the company has going for it prompted Mamtani to stay with the bulls. Along with a Buy rating, he kept his $5 price target as is, bringing the upside potential to 134%. (To watch Mamtani’s track record, click here)
Turning now to the rest of the Street, it has been quiet when it comes to other analyst activity. Mamtani’s call was the only one issued recently.
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