It’s been an event­ful 12 months or so for the omega-3 mar­ket, but one com­pa­ny’s lat­est at­tempt to use the ap­proach for se­vere hy­per­triglyc­eridemia came up short.

Cana­di­an biotech Acasti Phar­ma $AC­ST re­port­ed a sec­ond Phase III flop for its omega-3 phos­pho­lipid can­di­date CaPre on Mon­day, as the tri­al did not reach sta­tis­ti­cal sig­nif­i­cance for its pri­ma­ry end­point. The com­pa­ny stat­ed that, as a re­sult, it will not file for an NDA in the US nor con­duct ad­di­tion­al tri­als for the pro­gram.

Jan D’Alvise

“We are very dis­ap­point­ed in the out­come of the Tril­o­gy 2 study,” Acasti CEO Jan D’Alvise said in a state­ment. “While the triglyc­eride re­duc­tion ob­served in the con­trol arm was less than what was ob­served in the Tril­o­gy 1 Study, it still re­mains one of the high­est seen amongst the pre­vi­ous­ly con­duct­ed triglyc­eride re­duc­tion stud­ies.”

Acasti shares, which were al­ready in pen­ny-stock ter­ri­to­ry, fell 65% Mon­day fol­low­ing the news.

The com­pa­ny had been con­duct­ing two Phase III tri­als in par­al­lel, and af­ter Acasti re­port­ed that the first study didn’t hit sta­tis­ti­cal sig­nif­i­cance in Jan­u­ary, a path for­ward might still have re­mained had Mon­day’s re­sults proved more promis­ing. How­ev­er, that didn’t hap­pen, as both stud­ies saw “un­usu­al” triglyc­eride re­duc­tions in their place­bo arms.

Mon­day’s re­sults (“Tril­o­gy 2”) showed a 17.9% me­di­an re­duc­tion in triglyc­eride lev­els among pa­tients re­ceiv­ing place­bo at 12 weeks, as com­pared to 27.5% in the first Phase III (“Tril­o­gy 1”). Al­so, Acasti re­port­ed a 30.4% me­di­an re­duc­tion in triglyc­eride lev­els among all pa­tients re­ceiv­ing CaPre, as com­pared to the ear­li­er tri­al’s 30.5% rate.

That led to a p-val­ue of 0.19 for the un­ad­just­ed, place­bo-cor­rect­ed triglyc­eride re­duc­tion of 12.4%. Er­go, not sta­tis­ti­cal­ly sig­nif­i­cant.

The un­usu­al triglyc­eride re­duc­tion in the first Phase III spurred an au­dit of five test­ing sites which Acasti said in Feb­ru­ary dis­pro­por­tion­ate­ly con­tributed to the place­bo re­sponse. But in the sec­ond Phase III, the com­pa­ny be­lieves the tri­al “was like­ly not af­fect­ed by the same ‘Pre-Ran­dom­iza­tion Triglyc­eride Nor­mal­iza­tion’ ef­fect that we saw in Tril­o­gy 1,” D’Alvise said.

Fish oil omega-3 drugs have had their fair share of the spot­light re­cent­ly thanks to a patent fight be­tween the biotech Amarin and gener­ic drug­mak­ers. Af­ter Amarin re­ceived a block­buster FDA ap­proval last De­cem­ber for ex­pand­ing the use of Vas­cepa in­to pa­tients with el­e­vat­ed triglyc­eride lev­els, a US Dis­trict Court in­val­i­dat­ed the com­pa­ny’s IP in March.

Soon there­after, the FDA ap­proved the first Vas­cepa gener­ic in May, a copy of pure EPA from Hik­ma Phar­ma­ceu­ti­cals. But an­a­lysts at the time not­ed that a Hik­ma launch was not like­ly to take place any time soon giv­en the risks of a po­ten­tial suc­cess­ful ap­peal by Amarin.

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

Roche has another stack of data to back up its longer-acting challenger to Eylea — although it’s still far from certain just how much they can threaten Regeneron’s dominance.

The latest Phase III results come from two trials that enrolled 1,329 patients with neovascular age-related macular degeneration. With 45% of people in both studies getting faricimab 16 weeks apart during the first year, the bispecific still induced the same level of gains in visual acuity as Eylea every 8 weeks did, Roche’s Genentech reported.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.