Valo Announces First Patient Dosed in the OPL-0401 Phase 2 study of an oral ROCK1/2 inhibitor for the Treatment of Non-Proliferative Diabetic Retinopathy

Valo's Opal Computational Platform™ being used to select a patient subset within non-proliferative diabetic retinopathy patients at high risk of progressing toward vision-threatening disease

BOSTON, Aug. 18, 2022 /​PRNewswire/​— Valo Health, Inc. (“Valo”), the tech­nol­o­gy com­pa­ny focused on trans­form­ing the drug dis­cov­ery and devel­op­ment process using human-cen­tric data and arti­fi­cial intel­li­gence, today announced that dos­ing has com­menced in its Phase 2 study — a mul­ti-cen­ter ran­dom­ized, dou­ble-blind, place­bo-con­trolled study to eval­u­ate safe­ty and effi­ca­cy of oral OPL-0401 in patients with mild, mod­er­ate, and severe non-pro­lif­er­a­tive dia­bet­ic retinopa­thy (NPDR). OPL-0401 is an inves­ti­ga­tion­al small mol­e­cule Rho kinase (ROCK) 12 inhibitor and a poten­tial first-in-class oral option for patients with NPDR, where the cur­rent treat­ment options are intrav­it­re­al injec­tions, surgery, or laser treatment.

The Spec­tra study was designed using Val­o’s Opal Com­pu­ta­tion­al Plat­form which enabled real-world data analy­ses intend­ed to iden­ti­fy patient pop­u­la­tions that could poten­tial­ly ben­e­fit most from ear­ly treat­ment. Fur­ther, the study is designed to enable data cap­ture that can sup­port not only the expan­sion of Val­o’s data lake but also sub­se­quent analy­ses for fur­ther patient char­ac­ter­i­za­tion, response pre­dic­tion, and beyond.

Over 100 mil­lion patients have dia­bet­ic retinopa­thy world­wide, and there is a sig­nif­i­cant need to stop the pro­gres­sion of the dis­ease, espe­cial­ly in the ear­ly phas­es of this poten­tial­ly dev­as­tat­ing ill­ness” said Dave Mor­ris, MD, Pres­i­dent Tech­nol­o­gy and Ther­a­peu­tics at Valo Health. Valo intends to use Opal through­out OPL-0401’s devel­op­ment to improve pre­ci­sion and bet­ter tar­get our drugs to appro­pri­ate patients. This can take the form of using real-world data to inform patient selec­tion or uti­liz­ing data from our clin­i­cal tri­als to devel­op pre­dic­tive and prog­nos­tic bio­mark­ers to guide drug devel­op­ment and ther­a­peu­tic deci­sion making.”

We are thrilled to be using Val­o’s Opal Plat­form across the entire spec­trum of devel­op­ment: dis­cov­ery, trans­la­tion, and human clin­i­cal tri­als,” said David Berry, Val­o’s founder & Chief Exec­u­tive Offi­cer. It is our belief that the way to devel­op drugs faster and bet­ter is to match the mech­a­nism of the drug to the sub-pop­u­la­tion of patients most like­ly to ben­e­fit. Val­o’s Opal Plat­form gives us the tools to use data and AI/ML tech­nol­o­gy in order to accom­plish this. Impor­tant­ly, the data gen­er­at­ed will con­tin­ue to be used in an iter­a­tive fash­ion beyond our indi­vid­ual pro­grams. This con­tin­u­ous learn­ing process improves and accel­er­ates deci­sion mak­ing with the goal of iden­ti­fy­ing nov­el oppor­tu­ni­ties to ben­e­fit patients with OPL-0401 and oth­er Valo assets.”

Patients are in need of new ther­a­peu­tics with appro­pri­ate ben­e­fit-risk pro­files that can enable treat­ment of dia­bet­ic retinopa­thy ear­li­er in the course of dis­ease,” said Charles C. Wykoff, MD, PhD, Direc­tor of Research at Reti­na Con­sul­tants of Texas in Hous­ton and Spec­tra Lead Inves­ti­ga­tor. The com­pu­ta­tion­al enable­ment afford­ed by Val­o’s Opal Plat­form pro­vides an excit­ing oppor­tu­ni­ty to iden­ti­fy these patients who will ben­e­fit from an oral treat­ment option such as OPL-0401.” 

Addi­tion­al infor­ma­tion about Spec­tra (NCT05393284) can be found at www​.clin​i​cal​tri​als​.gov.

About OPL-0401

OPL-0401 is a ROCK (Rho-Kinase) 12 inhibitor with unique phys­io­chem­i­cal prop­er­ties that make it suit­able as an oral treat­ment option for patients with vas­cu­lar dis­eases of the eye such as DR. OPL-0401 has been found to be gen­er­al­ly safe and well tol­er­at­ed in Phase 1 and 2 stud­ies of > 200 healthy vol­un­teers includ­ing elder­ly, and indi­vid­u­als with renal insuf­fi­cien­cy. OPL-0401 has demon­strat­ed evi­dence of phar­ma­co­log­ic activ­i­ty in a non-oph­thal­mo­log­ic human vas­cu­lar dis­ease proof-of-prin­ci­ple study. OPL-401 is an inves­ti­ga­tion­al agent and has not been approved by the Food and Drug Admin­is­tra­tion, and its safe­ty and effi­ca­cy have not been established.

About Valo Health

Valo Health, Inc. (“Valo”) is a tech­nol­o­gy com­pa­ny built to trans­form the drug dis­cov­ery and devel­op­ment process using human-cen­tric data and arti­fi­cial intel­li­gence dri­ven com­pu­ta­tion. As a dig­i­tal­ly native com­pa­ny, Valo aims to ful­ly inte­grate human-cen­tric data across the entire drug devel­op­ment life cycle into a sin­gle uni­fied archi­tec­ture, there­by accel­er­at­ing the dis­cov­ery and devel­op­ment of life-chang­ing drugs while simul­ta­ne­ous­ly reduc­ing costs, time, and fail­ure rates. The com­pa­ny’s Opal Com­pu­ta­tion­al Plat­form is an inte­grat­ed set of capa­bil­i­ties designed to trans­form data into valu­able insights that may accel­er­ate dis­cov­er­ies and enable Valo to advance a robust pipeline of pro­grams across car­dio­vas­cu­lar meta­bol­ic renal, oncol­o­gy, and neu­rode­gen­er­a­tive dis­ease. Found­ed by Flag­ship Pio­neer­ing and head­quar­tered in Boston, MA, Valo also has offices in Lex­ing­ton, MA, New York, NY, Bran­ford, CT, and San Fran­cis­co, CA. To learn more, vis­it www​.val​o​health​.com

Investors: Graeme Bell, Chief Finan­cial Offi­cer, gbell@​valohealth.​com