DOJ opens criminal probe into Cassava over allegations of Alzheimer’s drug data manipulation — report

Months af­ter re­ports of al­le­ga­tions re­gard­ing Cas­sa­va Sci­ences’ lead drug can­di­date for Alzheimer’s emerged, the DOJ may now be rais­ing its head to in­ves­ti­gate the com­pa­ny.

A re­port from Reuters pub­lished this morn­ing said that two sources had con­firmed the US De­part­ment of Jus­tice opened an in­ves­ti­ga­tion in­to Cas­sa­va over al­le­ga­tions that the biotech had ma­nip­u­lat­ed search re­sults re­lat­ed to simu­fil­am, the com­pa­ny’s ex­per­i­men­tal Alzheimer’s drug.

The sources fur­ther told the out­let that the DOJ per­son­nel in­ves­ti­gat­ing Cas­sa­va “spe­cial­ize in ex­am­in­ing whether com­pa­nies or in­di­vid­u­als have mis­led or de­fraud­ed in­vestors, gov­ern­ment agen­cies or con­sumers.” The sources did not de­tail the fo­cus of the probe and if any­one spe­cif­ic was be­ing looked in­to.

Shares of $SA­VA were down ap­prox­i­mate­ly 30% in pre-mar­ket trad­ing af­ter clos­ing Tues­day at over $21 a share.

The SEC had start­ed in­ves­ti­gat­ing the com­pa­ny last No­vem­ber af­ter Cas­sa­va re­vealed that cer­tain un­named gov­ern­ment agen­cies had asked the com­pa­ny for doc­u­men­ta­tion, go­ing out of its way to say that the re­quests were not ac­cu­sa­tions of wrong­do­ing.

This saga got its start last Au­gust, af­ter law firm La­ba­ton Sucharow filed a cit­i­zen’s pe­ti­tion with the FDA on be­half of two doc­tors ask­ing the reg­u­la­to­ry agency to halt all the com­pa­ny’s clin­i­cal tri­als un­til the com­pa­ny’s da­ta had been au­dit­ed. The two doc­tors are neu­ro­sci­en­tist and Janssen’s for­mer chief of neu­ro­science dis­cov­ery David Bredt, and car­di­ol­o­gist Ge­of­frey Pitt, di­rec­tor of Weill Cor­nell Med­i­cine’s Car­dio­vas­cu­lar Re­search In­sti­tute.

The two doc­tors told the Wall Street Jour­nal in a sep­a­rate re­port last year that they had short­ed Cas­sa­va’s stock, bet­ting that the share price would fall once in­vestors rec­og­nized the prob­lems the pair found.

Ac­cord­ing to the re­port, the firm start­ed in­ves­ti­gat­ing Cas­sa­va af­ter find­ing re­sults “most un­ex­pect­ed and are prob­a­bly unique” to two sci­en­tists: re­searcher Hoau-Yan Wang at City Uni­ver­si­ty of New York and Cas­sa­va’s VP of neu­ro­sciences Lind­say Burns. The sci­en­tists had pub­lished mul­ti­ple pa­pers de­tail­ing the com­pa­ny’s hy­poth­e­sis about a con­nec­tion of fil­amin A pro­tein with Alzheimer’s dis­ease — and that simu­fil­am could ad­dress it.

How­ev­er, the law firm didn’t buy it. The re­port not­ed,

This ini­tial analy­sis sug­gests a pat­tern of clear er­rors and anom­alies that are con­sis­tent with da­ta ma­nip­u­la­tion and mis­rep­re­sen­ta­tion. These find­ings un­der­cut the foun­da­tion­al sci­ence on which simu­fil­am ther­a­py is based.

La­ba­ton Sucharow then point­ed to three types of da­ta it thought might be fal­si­fied: clin­i­cal bio­mark­er da­ta ap­par­ent­ly an­a­lyzed by Wang’s lab; West­ern blot analy­sis that al­leged­ly bore marks of al­ter­ation; and re­search in­volv­ing hu­man brain tis­sue us­ing a method­ol­o­gy that La­ba­ton Sucharow said “de­fies log­ic.”

“Cas­sa­va Sci­ences be­lieves the claims made in this post re­gard­ing sci­en­tif­ic in­tegri­ty are false and mis­lead­ing,” a state­ment from Cas­sa­va said at the time. “The Com­pa­ny stands be­hind its sci­ence, its sci­en­tists and its sci­en­tif­ic col­lab­o­ra­tors, and is re­spond­ing to en­sure the facts are known and re­spect­ed.”

The FDA re­ject­ed the pe­ti­tion sev­er­al months lat­er in Feb­ru­ary ear­li­er this year. How­ev­er, the fed­er­al reg­u­la­to­ry agency de­nied the pe­ti­tion on pro­ce­dur­al grounds, re­ply­ing that the FDA is not per­mit­ted to ini­ti­ate in­ves­ti­ga­tions based on cit­i­zen pe­ti­tions

CDER di­rec­tor Pa­trizia Cavaz­zoni not­ed at the time that the FDA was con­cerned about the is­sues raised by the short sell­er.

“We take the is­sues you raise se­ri­ous­ly. Please note that your Pe­ti­tions are be­ing de­nied sole­ly on the grounds that your re­quests are not the ap­pro­pri­ate sub­ject of a cit­i­zen pe­ti­tion,” Cavaz­zoni wrote in her re­sponse to the firm. “This re­sponse does not rep­re­sent a de­ci­sion by the Agency to take or re­frain from tak­ing any ac­tion re­lat­ing to the sub­ject mat­ter of your Pe­ti­tions.”

End­points News has reached out to Cas­sa­va for con­fir­ma­tion and com­ment — and we will up­date once we hear back.