CNS biotech's stock dives — again — as lead can­di­date fails sec­ond PhI­II test

On Wednes­day, Rel­ma­da Ther­a­peu­tics ran in­to yet an­oth­er ma­jor prob­lem for its lead can­di­date, two months af­ter fac­ing an ear­li­er set­back.

The CNS-fo­cused biotech re­vealed that REL-1017, its lead can­di­date that it has been de­vel­op­ing for ma­jor de­pres­sive dis­or­der, failed to reach the pri­ma­ry end­point in a Phase III study, look­ing at the drug as an ad­junc­tive treat­ment. The end­point was a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in de­pres­sion symp­toms com­pared to place­bo at 28 days, mea­sured by the Mont­gomery-As­berg De­pres­sion Rat­ing Scale.

In the study, the 113 pa­tients in the REL-1017 treat­ment arm saw a re­duc­tion of 15.1 points on the de­pres­sion scale af­ter 28 days, com­pared to 12.9 days for the 114 pa­tients on place­bo.

In­vestors took is­sue with Rel­ma­da $RLMD, send­ing the biotech’s shares spi­ral­ing more than 50% to un­der $2 a share as the mar­ket opened Thurs­day morn­ing. Its stock price has fall­en more than 90% since Sep­tem­ber, wip­ing away hun­dreds of mil­lions of dol­lars in mar­ket share af­ter REL-1017 failed to meet the pri­ma­ry end­point in a Phase III MDD tri­al as a monother­a­py.

That tri­al showed that af­ter 28 days, pa­tients who took the drug saw their scores de­crease by 14.8 points com­pared to 13.9 points from those on place­bo. Rel­ma­da re­port­ed a p-val­ue of p=0.28 at 28 days.

The biotech point­ed the fin­ger again at the same fac­tors that it blamed for a pre­vi­ous tri­al fail­ure, in­clud­ing “a lim­it­ed num­ber of high en­rolling sites with un­plau­si­ble place­bo re­sponse.” Per a state­ment, “im­plau­si­ble re­sults were again ob­served in two of the same high en­rolling RE­LIANCE I (Study 301) study cen­ters, where place­bo dra­mat­i­cal­ly out­per­formed REL-1017.”

Ex­ecs told in­vestors and an­a­lysts on a con­fer­ence call Wednes­day dis­cussing the re­sults that the com­pa­ny will have dis­cus­sions with FDA, in­clud­ing whether a Phase II tri­al, which did show some pos­i­tive ef­fi­ca­cy da­ta, could be con­sid­ered suf­fi­cient as a suc­cess­ful study.

Rel­ma­da’s goal has been to cre­ate a de­pres­sion drug that acts rapid­ly, in con­trast to SS­RIs that could take weeks to start work­ing. The FDA had ap­proved a rapid-act­ing ther­a­py for MDD back in Au­gust, Ax­some’s Au­veli­ty, which is an NM­DA re­cep­tor an­tag­o­nist. REL-1017 is a ND­MA re­cep­tor “chan­nel block­er,” Rel­ma­da says.

Rel­ma­da said that it will con­tin­ue to en­roll pa­tients in RE­LIANCE II, an­oth­er on­go­ing Phase III tri­al look­ing at REL-1017 as a po­ten­tial ad­junc­tive treat­ment for MDD. How­ev­er, it did say that Rel­ma­da will be im­ple­ment­ing some undis­closed pro­to­col and op­er­a­tional changes to the tri­al, and ad­di­tion­al­ly mak­ing “cer­tain im­prove­ments” to how the tri­al is run.

RE­LIANCE II is the biotech’s last Phase III tri­al look­ing at REL-1017 in MDD.

Rel­ma­da de­clined to com­ment to End­points News out­side of a state­ment and the ear­li­er con­fer­ence call.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

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