My­ovant has long had a se­cret weapon in its uter­ine ri­val­ry with Ab­b­Vie: Men.

Lynn Seely My­ovant

While the small Swiss biotech has jock­eyed with the Illi­nois-based gi­ant for a foothold in the en­dometrio­sis and uter­ine fi­broid ther­a­py mar­ket, the com­pa­ny has been de­vel­op­ing the same lead com­pound, re­l­u­golix, for use in one of the most com­mon can­cers for the uterus-less: prostate can­cer. To­day, My­ovant is out with pos­i­tive topline re­sults from its big Phase III tri­al on the go­nadotropin-re­leas­ing hor­mone (GnRH) an­tag­o­nist. They say they’ve reached every pri­ma­ry and sec­ondary end­point with p val­ues less than .0001.

“It works quick­ly,” CEO Lynn Seely told End­points News. “It’s an oral pill and it sup­press­es hor­mone pro­duc­tion and when you stop it, your hor­mones come back and you have the po­ten­tial for im­proved qual­i­ty of life.”

My­ovant’s stock is up 95% pre­mar­ket, from $6.06 to $11.80 per share

The tri­al test­ed a re­l­u­golix arm along­side a stan­dard-of-care, le­upro­lide, arm in their abil­i­ty to sup­press testos­terone in pa­tients with ad­vanced prostate can­cer. Testos­terone fu­els prostate can­cer’s growth. The pri­ma­ry end­point was the per­cent­age of men who reached and main­tained med­ical cas­tra­tion, or less than 50 nanograms of testos­terone per deciliter, over 48 weeks.

Re­l­u­golix achieved that in 96.7% of pa­tients — safe­ly clear­ing the FDA’s stat­ed bench­mark for ap­proval of 90%, Seely said. For Japan­ese and Eu­ro­pean ap­proval, they need­ed to show non-in­fe­ri­or­i­ty and did so, with their le­upro­lide arm show­ing on­ly an 88% re­sponse rate.

The re­sults set up an FDA ap­pli­ca­tion in Q2 of 2020 and Eu­ro­pean and Japan­ese ap­pli­ca­tions short­ly there­after, adding to the com­pa­ny’s im­mi­nent US ap­pli­ca­tion for uter­ine fi­broid ther­a­py.

The un­der­ly­ing mech­a­nism be­hind the two ther­a­pies is es­sen­tial­ly in­versed. Le­upro­lide is a GnRH ag­o­nist and de­sen­si­tizes the re­cep­tor by hit­ting it re­peat­ed­ly. Re­l­u­golix blocks it di­rect­ly.

My­ovant’s pitch cen­ters around the speed at which the drug worked, its pill form — rather than le­upro­lide, which is in­ject­ed every three months — and the ta­per­ing of some side ef­fects, which can be lengthy when it comes to testos­terone sup­pres­sion, in­clud­ing hot flash­es, fa­tigue, loss of mus­cle mass, sex­u­al dys­func­tion and de­pres­sion. Doc­tors have some­times giv­en “drug hol­i­days” to man­age the clin­i­cal ben­e­fit against the costs.

“Low­er­ing the testos­terone is bet­ter for treat­ing prostate can­cer,” Seely said. “But it’s not great for the man.”

The ad­verse event ra­tio for both drugs was around 93%, but Seely not­ed a low­ered rate of ma­jor car­dio­vas­cu­lar events in the re­l­u­golix group, 2.9% com­pared to 6.2%. The biotech al­so said hor­mone lev­els re­turned to nor­mal 90 days af­ter treat­ment in the re­l­u­golix group while some­times re­main­ing re­duced at that point or longer for le­upro­lide pa­tients — al­though they did not an­nounce spe­cif­ic num­bers.

So why isn’t Ab­b­Vie, My­ovant’s uter­ine ri­val, pur­su­ing a prostate treat­ment? Seely’s best guess is that it’s be­cause Ab­b­Vie’s GnRH an­tag­o­nist’s half-life is much short­er than My­ovant’s. Ab­b­Vie re­quires high­er dos­es in their uter­ine treat­ments than My­ovant gives — which would mean even high­er dos­es in the prostate ther­a­pies, she said.

The ques­tion, though, is if le­upro­lide is still large­ly ef­fec­tive and the side ef­fects most­ly the same, will doc­tors pre­scribe a new pill in­stead?

“I think the biggest con­cern is that le­upro­lide … has been in the field for decades,” she said. “Some peo­ple ques­tion if on­col­o­gists and urol­o­gists will change their prac­tice.”

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.