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.

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The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

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