AstraZeneca hands off epilepsy programs to Ovid; Amylyx scores priority review for ALS drug

Still re­cov­er­ing from a set­back in its lead pro­gram, Ovid Ther­a­peu­tics has turned to As­traZeneca for a suite of ex­per­i­men­tal epilep­sy drugs.

Ovid is pay­ing the Big Phar­ma part­ner $5 mil­lion in cash and $7.5 mil­lion in stock to ac­cess a li­brary of ear­ly-stage small mol­e­cules tar­get­ing the KCC2 trans­porter, in­clud­ing lead can­di­date OV350. As­traZeneca stands to re­ceive mile­stones adding up to more than $200 mil­lion and re­tains an op­tion for a strate­gic col­lab­o­ra­tion.

The epilep­sy fran­chise did rel­a­tive­ly well in a year full of bad news for Ovid, as Take­da bought back rights to soti­cle­stat, a cho­les­terol 24-hy­drox­y­lase in­hibitor in Phase III tri­als for Dravet and Lennox Gas­taut syn­dromes.

Oth­er than OV350, Ovid al­so got its hands on OV329, a new ver­sion of pre­ga­balin for tuber­ous scle­ro­sis and in­fan­tile spasms, which is ex­pect­ed to en­ter the clin­ic in 2022.

‘The KCC2 trans­porter is an ex­cit­ing and nov­el tar­get that we be­lieve holds great promise in treat­ing epilep­sies,’ CEO Je­re­my Levin said in a state­ment. ‘The com­pounds are a nat­ur­al fit for our fran­chise ded­i­cat­ed to small mol­e­cule epilep­sy med­i­cines, and they fol­low our track record of suc­cess­ful part­ner­ing with large phar­ma­ceu­ti­cal com­pa­nies.’

As­traZeneca had worked with Stephen Moss and Jamie Maguire at the Tufts Lab­o­ra­to­ry for Ba­sic and Trans­la­tion­al Neu­ro­science Re­search to de­vel­op these com­pounds. Ovid said it will con­tin­ue col­lab­o­rat­ing with them. — Am­ber Tong

Amy­lyx scores pri­or­i­ty re­view for ALS drug 

Af­ter years of fu­tile ef­forts, the FDA is ready to make a de­ci­sion on a po­ten­tial new amy­otroph­ic lat­er­al scle­ro­sis drug in six months — but not be­fore con­ven­ing an ad­vi­so­ry com­mit­tee.

Amy­lyx an­nounced over the hol­i­day that its on­ly drug, AMX0035, has been grant­ed pri­or­i­ty re­view and as­signed a PDU­FA date of June 29, 2022. But the FDA not­ed it’s plan­ning to hold an ad­comm to dis­cuss the NDA.

Ex­perts will like­ly be dis­sect­ing da­ta from the Phase II CEN­TAUR tri­al, where ALS pa­tients demon­strat­ed sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in clin­i­cal de­cline.

While reg­u­la­tors had asked last year for a Phase III study to con­firm those ben­e­fits, they lat­er re­versed course, flash­ing the green light for Amy­lyx to file di­rect­ly for ap­proval amid an up­roar in the ALS com­mu­ni­ty over what they saw as dou­ble stan­dards in the wake of the con­tro­ver­sial Aduhelm ap­proval. — Am­ber Tong

Eli Cas­din-backed DNA se­quenc­ing play­er tacks $35M more on­to Se­ries C

DNA Script has tacked on an­oth­er bun­dle of cash, of­fi­cial­ly clos­ing its Se­ries C.

The South San Fran­cis­co-based com­pa­ny com­plet­ed the round’s sec­ond tranche of $35 mil­lion, it an­nounced Tues­day, adding to the $165 mil­lion raised in the Se­ries C last Oc­to­ber. New funds come from T. Rowe Price As­so­ci­ates, Bail­lie Gif­ford, Health­cor Man­age­ment, eu­reKARE and Irv­ing In­vestors.

Al­so backed by Eli Cas­din, DNA Script is look­ing to make a mark on the DNA se­quenc­ing field by cut­ting down on ex­pen­sive and messy byprod­ucts as­so­ci­at­ed with ear­li­er ver­sions of se­quenc­ing tech­nol­o­gy. The com­pa­ny, found­ed in 2014, is gear­ing up for its first prod­uct launch this year, a bench­top DNA print­er us­ing a plat­form known as SYN­TAX.

The com­pa­ny hopes to even­tu­al­ly de­liv­er ther­a­peu­tics for per­son­al­ized and pre­ci­sion med­i­cine.

‘SYN­TAX is the first step to­ward cre­at­ing a new par­a­digm for DNA and RNA syn­the­sis,’ CEO Thomas Ybert said in a state­ment. ‘With the sup­port of our in­vestors, we look for­ward to con­tin­u­ing to ad­vance this new par­a­digm to solve some of our largest chal­lenges and ad­vance hu­man health.’ — Max Gel­man

Af­ter al­most a year, the FDA lifts clin­i­cal tri­al hold on Spero’s lung dis­ease can­di­date

Spero Ther­a­peu­tics got a breath of fresh air from the FDA — the agency lift­ed its hold on Spero’s planned Phase II tri­al for SPR720, a drug can­di­date for non­tu­ber­cu­lous my­cobac­te­r­i­al dis­ease, a bac­te­r­i­al in­fec­tion in the lungs.

The Phase IIa tri­al was of­fi­cial­ly put on hold back in Feb­ru­ary last year af­ter Spero no­ti­fied reg­u­la­tors of its de­ci­sion to pause dos­ing.

Sci­en­tists had un­cov­ered ‘mor­tal­i­ties with in­con­clu­sive causal­i­ty’ in a tox­i­col­o­gy study in­volv­ing non-hu­man pri­mates, and a Safe­ty Re­view Board rec­om­mend­ed that Spero hit the brakes on the drug, which it had ac­quired from Ver­tex. Spero’s stock $SPRO went down more than 20% to $4.04 af­ter the news broke.

Spero said ear­li­er to­day that it plans to meet with the FDA by the end of the quar­ter to dis­cuss restart­ing the tri­al, and hope to have it run­ning by next quar­ter.

CEO Ankit Ma­hade­via ex­pressed op­ti­mism, say­ing in a pre­pared state­ment ‘We are very pleased with the FDA’s de­ci­sion and ea­ger to bring SPR720 back in­to the clin­ic.’ — Paul Schloess­er 

Boast­ing ‘com­pre­hen­sive cov­er­age of breast can­cer,’ Chi­na’s Xu­anzhu nabs $96M

As the tune of the in­no­v­a­tive drug busi­ness gets loud­er in Chi­na’s phar­ma in­dus­try, a biotech spun out of a 20-year-old play­er has bagged $96 mil­lion in Se­ries B cash.

Xu­anzhu Bio­pharm plans to de­ploy the cash on de­vel­op­ing its sprawl­ing pipeline, which has more than 25 pro­grams, in­clud­ing two in the NDA stage: anapra­zole sodi­um for duo­de­nal ul­cer, and an SGLT-2 in­hibitor for di­a­betes.

Re­tain­ing close ties to its par­ent com­pa­ny Si­huan Phar­ma­ceu­ti­cal Hold­ings Group, Xu­anzhu says it’s fo­cus­ing on the R&D of ‘new fron­tier drugs’ in ar­eas like on­col­o­gy, di­a­betes, NASH, an­ti-in­fec­tion and di­ges­tion dis­or­ders.

Specif­i­cal­ly, Xu­anzhu said its 400 staffers main­ly tar­get breast can­cer, lung can­cer and oth­er sol­id tu­mors — mak­ing it ‘one of the com­pa­nies with the most com­pre­hen­sive cov­er­age of breast can­cer do­mes­ti­cal­ly.’

Oth­er on­col­o­gy drugs in de­vel­op­ment in­clude a next-gen­er­a­tion CDK4/6 in­hibitor and an ALK/ROS1 dual-tar­get in­hibitor.

‘(W)e will grad­u­al­ly ex­pand the com­pre­hen­sive strength en­com­pass­ing over­seas col­lab­o­ra­tion, in­dus­tri­al­iza­tion and com­mer­cial­iza­tion, and cre­ate a nov­el, in­no­v­a­tive pipeline and port­fo­lio that is dif­fer­en­ti­at­ed and sus­tain­able,’ CEO Yan­jun Xu said in a state­ment. — Am­ber Tong

No­var­tis keeps gener­ic chal­lenger out of Gilenya’s way 

Thanks to a new court rul­ing, No­var­tis can now guar­an­tee that it can con­tin­ue sell­ing its mul­ti­ple scle­ro­sis drug Gilenya with­out any gener­ic com­pe­ti­tion in the US at least for the next two years.

The Swiss phar­ma gi­ant an­nounced that the US Court of Ap­peals has up­held a patent cov­er­ing a dos­ing reg­i­men of Gilenya, mean­ing a per­ma­nent in­junc­tion against the gener­ic mak­er HEC Phar­ma will re­main in place un­til that patent ex­pires in De­cem­ber 2027.

Hav­ing reached set­tle­ment agree­ments with a num­ber of ab­bre­vi­at­ed new drug ap­pli­ca­tion fil­ers, pre­clud­ing them from launch­ing copy­cat ver­sions of Gilenya, No­var­tis said HEC Phar­ma was the on­ly re­main­ing AN­DA fil­er chal­leng­ing the patent.

The po­ten­tial gener­ic en­try date and oth­er terms, it added, are con­fi­den­tial. — Am­ber Tong
https://endpts.com/astrazeneca-hands-off-epilepsy-programs-to-ovid-amylyx-scores-priority-review-for-als-drug/