Ev­gen poised for piv­otal year

Web­site: www.ev­gen.com

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2018 is a key year in the de­vel­op­ment of Ev­gen

Pharma (EVG:AIM), the Cheshire-based busi­ness which has made rapid progress since join­ing AIM.

It now has two Phase II clin­i­cal tri­als un­der­way, one in ad­vanced breast cancer and one in a type of stroke known as sub­arach­noid haem­or­rhage (SAH).

Dur­ing June 2018, the com­pany will an­nounce its first-ever Phase II clin­i­cal data. The data will be the in­terim read-out from the breast cancer trial. The com­pany is on track to an­nounce the final read-outs from both tri­als around the end of 2018.

Steve Franklin, Ev­gen’s CEO, says: ‘This is a tremen­dously ex­cit­ing year for us as we are on track to an­nounce a sub­stan­tial amount of clin­i­cal trial data, which is what we have been work­ing to­wards since join­ing AIM in Oc­to­ber 2015.’

LAY­ING THE FOUN­DA­TIONS

Ev­gen was founded in 2007 to have a lower risk pro­file than many in its peer group. Its drug pipe­line is based on sul­foraphane, a nat­u­rally oc­cur­ring mol­e­cule orig­i­nat­ing in bras­si­cas such as broccoli. A huge amount of aca­demic re­search has been pub­lished on sul­foraphane, high­light­ing its po­ten­tial in med­i­cal con­di­tions rang­ing from solid tu­mour can­cers through mul­ti­ple scle­ro­sis, Parkin­son’s dis­ease and autism.

Whilst com­pelling, this aca­demic work has yet to be trans­lated into a mar­keted medicine be­cause of the dif­fi­cul­ties of cre­at­ing a sul­foraphane-based drug. Ev­gen has over­come these chal­lenges; its patent­pro­tected Sul­foradex plat­form en­ables the man­u­fac­ture of pro­pri­etary, syn­thetic and stable sul­foraphanebased drugs. Since IPO, the com­pany has been build­ing out its patent es­tate in re­la­tion to sul­foraphane with a view to es­tab­lish­ing a dom­i­nant world­wide po­si­tion in sul­foraphane-based drugs and re­lated com­pounds.

SFX-01, the com­pany’s lead prod­uct, is the first of these syn­thetic drugs and is cur­rently be­ing in­ves­ti­gated in Phase II tri­als in both ad­vanced breast cancer and SAH. SFX-01 rep­re­sents the first of an as­pir­ing new class of phar­ma­ceu­ti­cals, un­der­lin­ing its com­mer­cial value and its po­ten­tial to have a ma­jor im­pact on pa­tient out­comes.

SFX-01 is be­ing used as a po­ten­tial treat­ment in two very dif­fer­ent ther­a­peu­tic ar­eas be­cause of its abil­ity to in­flu­ence two con­trast­ing bio­chem­i­cal dis­ease path­ways, one in cancer and the other in neu­ro­log­i­cal dis­eases. Prod­uct lines con­tain­ing SFX-01 can be dif­fer­en­ti­ated by both dose and/or for­mu­la­tion.

PO­TEN­TIAL CANCER TREAT­MENT

In cancer, SFX-01 has the abil­ity to in­hibit the tar­get STAT3 thereby pre­vent­ing the bio­chem­i­cal se­quence that re­sults in the gen­er­a­tion of cancer stem cells and tu­mour metas­tases. In neu­ro­log­i­cal dis­eases, SFX-01 ac­ti­vates the tar­get Nrf2 thereby stim­u­lat­ing pro­duc­tion of

cy­to­pro­tec­tive pro­teins to com­bat ox­ida­tive stress and in­flam­ma­tion.

Dr Franklin says: ‘Mech­a­nis­tic stud­ies have shown that SFX-01 tar­gets cancer stem cells in both early and metastatic breast can­cers and has the po­ten­tial to over­come hor­mone re­sis­tance in ER+ breast can­cers. This mech­a­nis­tic work con­tin­ues via col­lab­o­ra­tions with Im­pe­rial Col­lege London and the Univer­sity of Manch­ester.’

Ev­gen Pharma’s STEM (SFX-01 in the Treat­ment and Eval­u­a­tion of Metastatic Breast Cancer) trial is a multi-cen­tre, Phase IIa clin­i­cal trial re­cruit­ing a to­tal of 60 pa­tients from mul­ti­ple sites in the UK, Bel­gium, France and Spain and led from the Christie Hos­pi­tal in Manch­ester. STEM pa­tients have ER+ metastatic breast cancer and have been on hor­mone treat­ment.

Pa­tients who join the trial have re­sponded to hor­mone ther­apy for at least six months but then show hor­mone re­sis­tance via tu­mour growth. Once on the trial, pa­tients con­tinue to re­ceive their fail­ing hor­mone ther­apy in ad­di­tion to SFX-01 and have reg­u­lar scans through to week 24, leav­ing the trial im­me­di­ately on con­firmed tu­mour growth or symp­to­matic clin­i­cal pro­gres­sion.

The trial had an im­por­tant milestone in June last year when a com­pas­sion­ate use pro­gramme was ini­ti­ated af­ter the first pa­tient reached week 24 with­out dis­ease pro­gres­sion; the pro­gramme en­ables such pa­tients to re­ceive SFX-01 on an on­go­ing ba­sis.

Dr Franklin says: ‘The pa­tients in our first ex­ploratory trial have be­come re­sis­tant to hor­mone ther­a­pies and have pro­gres­sive dis­ease, with lit­tle other treat­ment op­tions. In this sal­vage set­ting, which is the high­est ef­fi­cacy chal­lenge there is for any new drug, clin­i­cians will be look­ing to see if SFX-01 is safe, well-tol­er­ated and can halt pro­gres­sion. We are in­formed by our clin­i­cal ad­vi­sors that if 20% or more of pa­tients have their tu­mour growth halted for the en­tire six months, which is a non-triv­ial chal­lenge in this pa­tient group, then we have an in­ter­est­ing drug on our hands.’

ON THE THRESH­OLD

Breast cancer af­fects a very large num­ber of peo­ple whereas the com­pany’s other Phase II trial, in SAH, is study­ing a rel­a­tively rare con­di­tion, ac­count­ing for around only 5% of all strokes. SAH is the form of stroke re­cently suf­fered by Sir Alex Fer­gu­son, the former Manch­ester United man­ager. There has been no new drug for SAH since the launch in the 1980s of ni­modip­ine, the cur­rent stan­dard of care. Whilst af­fect­ing a rel­a­tively small num­ber of peo­ple, SAH is an at­trac­tive niche mar­ket await­ing a new treat­ment op­tion.

Ev­gen Pharma’s Phase II trial of SFX-01 in SAH is a dou­ble­blind, placebo-con­trolled study of 90 pa­tients; 45 of them re­ceiv­ing ni­modip­ine and placebo and 45 re­ceiv­ing ni­modip­ine and SFX-01. This trial is also on track to read out at around the end of this cal­en­dar year.

Dr Franklin says: ‘Ev­gen Pharma is an ex­cit­ing com­pany on the thresh­old of its first Phase II trial data. The wealth of ex­ist­ing sci­en­tific data on sul­foraphane gives us con­fi­dence as we pur­sue our strat­egy of lead­ing the de­vel­op­ment of this new class of drugs and tak­ing own­er­ship in all key com­mer­cial mar­kets of the in­tel­lec­tual prop­erty sur­round­ing sul­foraphanebased medicine.’

Steve Franklin: Ev­gen Pharma CEO

Stable struc­ture: SFX-01 is a syn­thetic ver­sion of sul­foraphane sta­bilised in a sugar lat­tice

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