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Like most four-and-a-half-year-olds, Lev Bielski loves playing with his big sister, spelling his favorite pastime “pool” on the letter board, and cuddling with his parents on movie nights.
But it’s been a long journey for the golden-haired “surfer bro” who loves splashing in the water at surf camp and trying on Dad’s volunteer firefighter gear.
Up until four months ago, Lev was self-harming until he was black and blue, unable to make eye contact and keeping to himself in a corner all day. He was inching dangerously close to being confined by a punishing helmet and sedated with heavy antipsychotic meds to mitigate his severe autism that left him incapable of functioning by himself.
The outlook was bleak for the tormented tyke, who showed symptoms before he was a year old.
His parents, Gabriella and Matthew Bielski, chased every therapeutic intervention and specialist across the country for years, to no avail. The family desperately needed a lifeline, as no medication is approved to address the core symptoms related to autism.
“Half my day was running a business and half was holding him down and trying to keep him from hurting himself — we had no solution,” Matthew Bielski told The Post.
That was until research led the anguished couple to Yamo Pharmaceuticals, a decade-old clinical-stage biopharmaceutical company dedicated to treating the core symptoms of autism spectrum disorder with its “miracle drug” called L1-79.
They managed to get Lev the therapy before FDA approval thanks to the FDA’s expanded-access program — and the results, they said, were immediate.
“It was the next day,” Bielski said. “It was right away and other people in all the phases said the same thing.”
“It changed everything for us,” he added, beaming over Lev’s “life-changing transformation.”
Overjoyed over his “miracle kid,” Bielski predicted the drug will be the “Ozempic of autism.”
What separates this investigational oral therapy from other treatments is its focus on brain signaling involved in social interaction, rather than just the behaviors surrounding autism.
With FDA fast track designation, Yamo said L1-79 is poised to become the first FDA-approved therapy for the core symptoms of autism, with the potential to transform the lives of millions. And as the drug moves into crucial Phase 3 trials, Bielski is determined to see that happen.
“We hope that the FDA works closely with Yamo because right now there’s zero solutions, and this has the best shot of being that,” he said.
The determination of a dad
The 42-year-old Wall Street honcho is drawing on his family’s history of fighting for survival to protect his son.
The Hamptonite is a descendant of the legendary Bielski brigade of partisans. The band of four Jewish brothers rescued 1,200 Jews from certain death and eliminated Nazis while hiding deep inside the Belarussian Naliboki forest during the Holocaust.
His family story was immortalized in the movie “Defiance,” with Liev Schreiber portraying his fearless grandpa Zus.
“I grew up with stories of survival and fighting back,” Bielski, founder and CEO of a leading ETF issuer, Defiance ETFs, said of his formative memories. That’s become a mandate he carries with him today to fight for Lev and the scores of other kids fighting for a chance at a better life.
‘He’s excited to take it’
With about one out of every 31 kids diagnosed with autism, the “groundbreaking” drug could change millions of lives, according to Dr. Tom Megarian, a veteran pediatric neurologist and CMO & EVP of Clinical Development at Yamo.
Early trials were promising.
Phase 2 results from a 12-week study presented last year showed what Yamo described as “unprecedented” gains in socialization, alongside critical strides in communication skills and speech patterns, with parents describing an overnight transformation.
“He went from the least affectionate kid to the most affectionate kid almost overnight.”
Matthew Bielski
“As a clinician practicing in this space for 30 years, I’ve never seen that level of improvement in that short a period of time. I haven’t even seen that level of improvement in that many children over years of therapy,” said Dr. Megarian.
“Our biggest barrier right now is getting the funding that we need to move forward,” he added.
Yamo boasted a highly favorable safety profile — a key distinction from the potentially serious side effects associated with antipsychotic medications.
“The benefit has been almost miraculous, and there have been no serious side effects,” Dr. Eric Bartky, a child, adolescent and adult psychiatrist who treats Lev, told The Post, noting the positive outcomes for mild to severe cases.
It’s what every parent dreams of.
Jarret Niesse gushed that “it was a couple of days” before witnessing his daughter Payton’s revolutionary shift, while Payton’s mom, Corrie, cried, “She wouldn’t stop talking… I could have a conversation with her. It was wonderful.”
Payton dreams of more time on the meds. “I want to be back on that medicine,” said the teen, noting the potential to help scores of others go through life.
Taking the oral formula administered twice a day is a highlight for Lev. “He’s excited to take it because he kind of knows it’s helping him,” said Bielski.
Hebrew for “heart,” Lev is certainly living up to his name, according to his dad, who noted that his son loves to hug and be engaged with the world around him.
“He went from the least affectionate kid to the most affectionate kid almost overnight.”
Every child deserves a chance to connect with their parents, the Bielskis said.
But even with the all-important FDA fast track designation, Yamo still needs $75 million in order to move to the pivotal Phase 3 trials with enough meds to support the full study.
Family resolve paid off, and Bielski is betting big on the revolutionary drug. Along with his wife, he’s personally investing in Yamo.
“I vowed to put the same energy and focus as I did into building my $15 billion business and help this drug company take its best shot at improving countless lives,” he said. “That includes the single mother raising a child with profound autism who may not have access to specialists.”
He also decided that Defiance would launch the first-of-its-kind Autism Impact ETF — symbol ASD — in which all net advisory profits for the first two years are donated to autism-related causes.
“The capital markets need to be opened up to autism drug development. Developing drugs for autism is difficult, risky and expensive,” said the investor. “But if investors don’t finance those risks, promising treatments may never receive the trials they need.”
While little 35-pound Lev may not have the physical stature of his great-grandpa and his brothers, Bielski asserted that he possesses the same spirit in fighting on the other battlefield: his health.
Since he started eating solid food — including veggies — for the first time under the drug four months ago, Lev has scored “a lot of massive big wins that I didn’t expect for decades,” admitted Bielski.
It’s the simple pleasures now that are the most meaningful for struggling families.
“For the first time in seven years, my son looked me in the eyes and said ‘good morning,’” beamed Maria, whose kid did beautifully during a Phase 2 trial.
Chris Milcsik said he used to feel like he was stuck in a washing machine agitator — but transformed during a one-month trial, from angry to “amicable.”
For Dr. Bartky, the future looks bright.
“Now there is more hope for families of children with autism, as there is always hope,” said the doc. “Imagine multiplying one Lev by millions — imagine that world.”
