Valo Health Completes Enrollment of OPL-0401 Phase 2 Study for the Treatment of Diabetic Retinopathy

BOSTON, March 4, 2024 /​PRNewswire/​– Valo Health, Inc (Valo), a tech­nol­o­gy com­pa­ny focused on uti­liz­ing large scale data and arti­fi­cial intel­li­gence (AI) dri­ven com­pu­ta­tion to dis­cov­er and devel­op ther­a­peu­tics, today announced full enroll­ment in the company’s Phase 2 Spec­tra clin­i­cal trial. 

Spec­tra is a mul­ti-cen­ter ran­dom­ized, dou­ble-blind, place­bo-con­trolled study to eval­u­ate the poten­tial ben­e­fit of oral OPL-0401 in patients with mod­er­ate­ly severe or severe non-pro­lif­er­a­tive dia­bet­ic retinopa­thy (NPDR) or mild pro­lif­er­a­tive dia­bet­ic retinopa­thy (PDR). OPL-0401 is an inves­ti­ga­tion­al small mol­e­cule Rho kinase (ROCK) 1 and 2 inhibitor and a poten­tial first-in-class oral option for patients with dia­bet­ic retinopa­thy (DR), where the cur­rent treat­ment options are lim­it­ed to patients with more severe or advanced vision-threat­en­ing lev­els and con­sist main­ly of intrav­it­re­al injec­tions and laser treat­ment. The com­pa­ny antic­i­pates a topline read­out before the end of 2024

Valo would like to thank the patients and tri­al inves­ti­ga­tors for their par­tic­i­pa­tion and con­tri­bu­tions to the study. 

We are encour­aged by the full enroll­ment of our Phase 2 tri­al ahead of our pro­ject­ed time­line, a strong tes­ta­ment to the poten­tial that new ther­a­pies could bring for patients felt by the health­care providers par­tic­i­pat­ing in this tri­al,” said Valo’s Chief Med­ical Offi­cer, Vic­tor Shi, MD. We are so grate­ful to the Spec­tra tri­al inves­ti­ga­tors, rec­og­niz­ing the oppor­tu­ni­ty and con­fi­dence in iden­ti­fy­ing a more effec­tive or con­ve­nient ther­a­py over cur­rent ther­a­peu­tic options, for their sup­port through tri­al enroll­ment completion.” 

Dia­bet­ic retinopa­thy has an esti­mat­ed preva­lence of approx­i­mate­ly 11 mil­lion peo­ple in the Unit­ed States and remains an under­served ill­ness, espe­cial­ly in ear­li­er stages of the dis­ease,” said Graeme Bell, Inter­im Chief Exec­u­tive Offi­cer of Valo Health. The study of OPL-0401 for oral deliv­ery rep­re­sents the poten­tial for sig­nif­i­cant improve­ment in the treat­ment of this pro­gres­sive and debil­i­tat­ing dis­ease. In addi­tion, we lever­aged Valo’s Opal Com­pu­ta­tion­al Plat­form™, our end-to-end drug dis­cov­ery and devel­op­ment plat­form, to iden­ti­fy bio­mark­ers that may pre­dict which patients are like­ly to progress to the next stage of DR, and are hope­ful to gain fur­ther insights from Spec­tra that could poten­tial­ly ben­e­fit future patients and clin­i­cal tri­al design and execution.”

Valo used its Opal Plat­form and unique access to real-world evi­dence to eval­u­ate the dia­bet­ic retinopa­thy patient pop­u­la­tion and OPL-0401 and its poten­tial. The company’s inter­nal pipeline of prod­uct can­di­dates and dis­cov­ery pro­grams uti­lize Opal, and the learn­ings from these pro­grams are inte­grat­ed and uti­lized to fur­ther devel­op its com­pu­ta­tion­al capabilities. 

There remains a tremen­dous unmet need for safe and effec­tive oral ther­a­peu­tics that can slow the pro­gres­sion of NPDR and PDR and improve dia­bet­ic retinopa­thy sever­i­ty lev­els,” said Charles C. Wykoff, MD, PhD, Direc­tor of Research at Reti­na Con­sul­tants of Texas in Hous­ton and Spec­tra Lead Inves­ti­ga­tor. Today, physi­cians often delay treat­ing patients with NPDR with cur­rent FDA-approved ther­a­peu­tics because of the need for repeat­ed intrav­it­re­al injec­tions. Spec­tra is a well-designed, proof of con­cept study that I hope will yield pos­i­tive results for patients with NPDR.”

About OPL-0401
OPL-0401 is a ROCK (Rho kinase) 1 and 2 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 (spon­sored by Sanofi pri­or to our acqui­si­tion of the pro­gram) 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-0401 is an inves­ti­ga­tion­al agent and has not been approved by the U.S. Food and Drug Admin­is­tra­tion (FDA), and its safe­ty and effi­ca­cy have not been established.

About Valo Health
Valo Health, Inc is a tech­nol­o­gy com­pa­ny focused on uti­liz­ing large scale data and AI-dri­ven com­pu­ta­tion to dis­cov­er and devel­op ther­a­peu­tics. 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 end-to-end drug dis­cov­ery and devel­op­ment plat­form with a uni­fied archi­tec­ture designed to trans­form data into valu­able insights that may accel­er­ate dis­cov­er­ies and enable Valo to advance a robust pipeline of pro­grams, ini­tial­ly focused on car­dio­vas­cu­lar meta­bol­ic renal, oncol­o­gy, and neu­rode­gen­er­a­tive dis­ease. Found­ed by Flag­ship Pio­neer­ing and head­quar­tered in Boston, MA, Valo also has offices in Lex­ing­ton, MA, and New York, NY. To learn more, vis­it val​o​health​.com.

Investors: Graeme Bell, gbell@​valohealth.​com
Media: Kate Clay­ton, kclayton@​valohealth.​com