KaNDy Chair­man Iain Dukes

Five years af­ter NeRRe Ther­a­peu­tics spun out of GSK with some of its un­want­ed work in neu­ro­sciences, the UK biotech is ex­e­cut­ing a spin­out of its own.

NeRRe has tak­en a neu­rokinin-1,3 re­cep­tor an­tag­o­nist — with po­ten­tial as a hor­mone re­place­ment ther­a­py — and hived it off in­to a new biotech called KaNDy Ther­a­peu­tics. Now KaNDy will take it in­to a Phase IIb study for post­menopausal va­so­mo­tor symp­toms.

Ad­vent Life Sci­ences, Foun­tain Health­care Part­ners, For­bion Cap­i­tal Part­ners and Or­biMed Ad­vi­sors are back­ing the com­pa­ny.

KaNDy Chair­man Iain Dukes had this to say:

The for­ma­tion of KaNDy Ther­a­peu­tics en­ables us to max­imise the po­ten­tial of NT-814 in a range of de­bil­i­tat­ing Women’s Health con­di­tions. We be­lieve NT-814 is one of the few true in­no­va­tions in Women’s Health in more than two decades and po­ten­tial­ly rep­re­sents a ma­jor break­through in ar­eas of sig­nif­i­cant un­met med­ical need such as PMVMS. Mary has built up an ex­cel­lent team who have made sub­stan­tial progress with NT-814 and we’re look­ing for­ward to ad­vanc­ing this ex­cit­ing new prod­uct in­to a Phase 2b pro­gramme.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.