Un­til a few years ago, GlyT1, a glycine trans­porter, seemed like a promis­ing tar­get for an add-on ther­a­py to treat neg­a­tive symp­toms of schiz­o­phre­nia.

But sci­en­tists were thrust­ed back to the draw­ing board in 2014, when Roche re­port­ed that its GlyT1 in­hibitor, bitop­er­tin, had failed two Phase III tri­als. A few months lat­er, they scrapped the pro­gram al­to­geth­er.

The drug sat on the shelves for sev­en years. Then Disc Med­i­cine came along.

The biotech, which had li­censed bitop­er­tin from Roche in a $200 mil­lion deal with an undis­closed up­front, has now nabbed $90 mil­lion in Se­ries B cash to take the drug in a com­plete­ly dif­fer­ent di­rec­tion: rare ge­net­ic dis­or­ders known as ery­thro­poi­et­ic por­phyr­ias.

Will Sav­age

Disc Med­i­cine had a lead pro­gram on its own: DISC-0974, an ane­mia drug that works by con­trol­ling iron me­tab­o­lism and is al­ready in the clin­ic. The hema­tol­ogy-fo­cused com­pa­ny, though, had been re­search­ing oth­er ways to treat dis­eases by go­ing af­ter “fun­da­men­tal com­po­nents” of path­ways re­lat­ed to red blood cells, said CEO John Quisel, so as to ful­ly take ad­van­tage of the ex­pert net­work and ca­pa­bil­i­ties it’s built.

One of those path­ways is heme syn­the­sis. In ery­thro­poi­et­ic por­phyr­ias, a buildup of por­phyrins lead to tox­ic re­ac­tions to sun­light — 30 min­utes un­der the sun could cause se­vere pain and a burn­ing sen­sa­tion.

Across a se­ries of cel­lu­lar and mouse ex­per­i­ments, re­searchers found that tar­get­ing a heme metabo­lite called pro­to­por­phyrin IX could fix the de­fect that re­sults in por­phyrin ac­cu­mu­la­tion.

Be­cause Roche had been look­ing at glycine con­trol as a way to treat schiz­o­phre­nia pa­tients, in­ves­ti­ga­tors had mea­sured those met­rics and showed that’s ex­act­ly what the drug did in pa­tients — even though they were “hema­to­log­i­cal­ly nor­mal.” Clin­i­cal da­ta from thou­sands of pa­tients al­so sug­gest a clean safe­ty pro­file.

While a host of GlyT1 in­hibitors had been cre­at­ed, many had failed in ear­li­er stages for safe­ty or oth­er rea­sons. Roche of­fered the best mol­e­cule with a sol­id clin­i­cal pack­age.

“It’s very rare to be able to move in­to a Phase II pro­gram with this kind of in­for­ma­tion al­ready es­tab­lished by Roche,” Quisel said.

“The task left for us at Disc is to demon­strate how much we are ad­dress­ing the un­met need in EPP pa­tients,” added Will Sav­age, who was pro­mot­ed to CMO last week as part of a quar­tet of lead­er­ship changes.

With the new cash in­fu­sion, the team — now stand­ing at 20 — ex­pects to have mul­ti­ple Phase II tri­als for bitop­er­tin and DISC-0974 up and run­ning, then se­cure proof-of-con­cept da­ta in 2023. Then there are the ear­ly-stage dis­cov­ery pro­grams lin­ing be­hind.

Or­biMed led the new round, joined by new in­vestors Ar­ix Bio­science, Janus Hen­der­son In­vestors, 5AM Ven­tures, Rock Springs Cap­i­tal, Nan­ta­ha­la Cap­i­tal Man­age­ment, Wil­lett Ad­vi­sors, and Alexan­dria Ven­ture In­vest­ments. Ex­ist­ing back­ers, in­clud­ing At­las Ven­ture, No­vo Hold­ings and Ac­cess Biotech­nol­o­gy, al­so par­tic­i­pat­ed.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.