When Ze­ga­logue, al­so known as dasiglucagon, got ap­proved by the FDA ear­ly last year for se­vere hy­po­glycemia in di­a­betes pa­tients, Zealand Phar­ma said that wasn’t the end of its vi­sion for the drug. One of the oth­er in­di­ca­tions they planned to pur­sue came in pe­di­atric pa­tients who had con­gen­i­tal hy­per­in­sulin­ism, a ge­net­ic dis­or­der where the pan­creas pro­duces too much in­sulin that re­sults in low blood sug­ar.

The re­sults are now in from a Phase III tri­al, and ac­cord­ing to the biotech, the pri­ma­ry end­point has been met. The pep­tide spe­cial­ist out­fit an­nounced Thurs­day that top-line re­sults from the tri­al, which en­rolled 12 ba­bies with the ge­net­ic con­di­tion (rang­ing from 12 months all the way down to just one week old), showed a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in pa­tients re­quir­ing in­tra­venous glu­cose be­tween treat­ment arms ver­sus place­bo.

In­vestors cheered the news, send­ing Zealand shares $ZEAL up 18% in Thurs­day morn­ing trad­ing.

In the study, Zealand re­port­ed the mean IV GIR, a mea­sure of how much glu­cose is re­quired to keep pa­tients’ blood sug­ar lev­els sta­ble, in pa­tients in the treat­ment arm and the place­bo arm. The base­line IV GIR was 15.7 mg/kg/minute. For pa­tients who took Ze­ga­logue, the lev­el was re­duced to 4.3 mg/kg/min, and re­duced to 9.4 mg/kg/min for the place­bo group, good for a 55% re­duc­tion.

That clocked in at a p-val­ue of p=0.0037. Ad­di­tion­al­ly, 11 of the 12 pa­tients in the study are mov­ing in­to an on­go­ing, safe­ty ex­ten­sion tri­al.

This study was the sec­ond Phase III that Zealand went with in CHI. The first study read out back in 2020 and looked at old­er chil­dren, en­rolling 32 pa­tients be­tween the ages of 3 months and 12 years old. The phar­ma re­port­ed at the time that the drug plus stan­dard of care did not sig­nif­i­cant­ly re­duce the rate of hy­po­glycemia com­pared to stan­dard of care alone when as­sessed by in­ter­mit­tent self-mea­sured plas­ma glu­cose.

How­ev­er, when com­pared to con­tin­u­ous glu­cose mon­i­tor­ing via an ex­plorato­ry analy­sis, hy­po­glycemia was re­duced by 40 to 50% with Ze­ga­logue as com­pared to stan­dard of care alone. The analy­sis led to 31 of those pa­tients to en­roll in the afore­men­tioned safe­ty ex­ten­sion tri­al.

The biotech added that now that the da­ta are in, it’s look­ing at meet­ing with the FDA and start to pur­sue an NDA sub­mis­sion for that in­di­ca­tion. Zealand said in a state­ment that it plans to have the sub­mis­sion done by year’s end.

“We are ex­treme­ly pleased with the top-line re­sults from our sec­ond Phase III study of dasiglucagon for the treat­ment of in­fants with CHI,” Zealand CEO Adam Steens­berg said in a state­ment, adding, “We look for­ward to en­gag­ing with the US FDA and mov­ing for­ward with our New Drug Ap­pli­ca­tion.”

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.