A month and a half lat­er, Gy­ro­scope Ther­a­peu­tics’ Phase I/II win for its dry-AMD gene ther­a­py is al­ready pay­ing off. On Fri­day, the biotech took the wraps off a $148 mil­lion Se­ries C round to ad­vance the can­di­date through two Phase II tri­als in pa­tients with a de­bil­i­tat­ing eye dis­or­der that caus­es grad­ual and per­ma­nent blind­ness.

Syn­cona — which found­ed Gy­ro­scope with Cam­bridge En­ter­prise — con­tributed $42.3 mil­lion to the Se­ries C round, and now main­tains a 54% stake in the Lon­don-based biotech.

Spark’s cost­ly Lux­tur­na made waves when it be­came the first gene ther­a­py ap­proved for in­her­it­ed blind­ness back in 2017. Since then, oth­er gene ther­a­pies for rare eye dis­or­ders have ad­vanced in de­vel­op­ment — but none have been ap­proved for dry, age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), a lead­ing cause of blind­ness in peo­ple over 50 years old. About 85% to 90% of peo­ple with AMD have the dry type, ac­cord­ing to Gy­ro­scope.

Gy­ro­scope’s lead can­di­date, GT005, is cur­rent­ly in two Phase IIs for pa­tients with ge­o­graph­ic at­ro­phy, an ir­re­versible de­gen­er­a­tion of reti­nal cells caused by dry-AMD. The can­di­date is in­ject­ed un­der the reti­na to in­crease pro­duc­tion of the Com­ple­ment Fac­tor I pro­tein, which Gy­ro­scope be­lieves could damp­en an over­ac­tive com­ple­ment sys­tem that’s been tied to wors­en­ing at­ro­phy in AMD pa­tients.

“We re­cent­ly an­nounced en­cour­ag­ing Phase I/II clin­i­cal tri­al da­ta with our lead in­ves­ti­ga­tion­al gene ther­a­py, GT005, that give us con­fi­dence in its po­ten­tial as a treat­ment for ge­o­graph­ic at­ro­phy and are con­tin­u­ing to ad­vance our Phase II clin­i­cal pro­gramme,” CEO Khurem Fa­rooq said in a state­ment.

Fa­rooq, a Genen­tech vet, over­saw com­mer­cial ac­tiv­i­ties for the wet-AMD drug Lu­cen­tis and pre-launch work for Roche’s lam­pal­izum­ab, a dry-AMD can­di­date that was dropped af­ter fail­ing two Phase III tri­als in 2017.

In a Phase I/II dose-es­ca­la­tion tri­al, pa­tients who re­spond­ed to GT005 saw a 146% in­crease in their vit­re­ous Com­ple­ment Fac­tor I lev­els as well as a de­crease in down­stream bio­mark­ers tied to ge­o­graph­ic at­ro­phy for pa­tients with dry AMD, ac­cord­ing to da­ta re­leased in mid-Feb­ru­ary.

Na­dia Wa­heed

At an in­ter­im check-in, nine out of 10 pa­tients across four co­hort groups saw in­creased CFI lev­els af­ter re­ceiv­ing the ther­a­py, and eight of those nine main­tained el­e­vat­ed lev­els of CFI af­ter six months, Gy­ro­scope said.

“Con­sis­tent­ly we’re hit­ting the tar­gets we want to hit in the down­stream am­pli­fi­ca­tion loop,” CMO Na­dia Wa­heed told End­points News last month. “Every­thing so far looks like it’s point­ing in the right di­rec­tion.”

The Se­ries C funds will al­so be used to ad­vance Gy­ro­scope’s ear­ly-stage pipeline and de­liv­ery tech, ac­cord­ing to a state­ment. The round was led by For­bion’s Growth Op­por­tu­ni­ties Fund, with a hand from Sofinno­va In­vest­ments, funds and ac­counts ad­vised by T. Rowe Price As­so­ci­ates, Tetragon Fi­nan­cial Group Lim­it­ed, an undis­closed health­care-fo­cused fund, Fo­s­un Phar­ma and Cam­bridge In­no­va­tion Cap­i­tal.

Wouter Jous­tra and Ma­ha Katabi, gen­er­al part­ners at For­bion and Sofinno­va, re­spec­tive­ly, are join­ing the board. And di­rec­tor Do­minic Schmidt is on his way out.

“With the ex­pan­sion of the Board it is the right time for Do­minic (Schmidt) to step down from his po­si­tion as Di­rec­tor. We thank Do­minic for his key role in the launch and growth of Gy­ro­scope and his sup­port of the Com­pa­ny,” chief in­vest­ment of­fi­cer Chris Hol­lowood wrote in a state­ment.

Last month, Wa­heed told us the Phase I/II FO­CUS tri­al would fin­ish en­roll­ment by the end of 2021, and that the team was “on track” to fill out en­roll­ment in the two Phase II ef­fi­ca­cy tri­als.

A cor­rec­tion has been made to re­flect that Lux­tur­na is the on­ly oc­u­lar gene ther­a­py cur­rent­ly ap­proved.

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.