HOLLY SPRINGS — Less than two years after launching, a small Triangle biotech startup is kicking off its first human trial in Malaysia for a novel drug therapy treating pruritus, or chronic itchy skin.

Avior Bio, a clinical-stage pharmaceutical company developing drugs for distressed neurological conditions, has initiated its first dose after receiving the green light from the Malaysian Ministry of Health.

Its lead product — AV104 — is based on Avior’s patent-pending delivery technology called Speedit Transmucosal Film to treat severe pruritus.

“With the initiation of our first-in-human study, we are at a pivotal juncture at Avior,” said Niraj Vasisht, founder and CEO of Avior Bio. “We decided to pursue Malaysia as a clinical site,” he added, “because of their top-notch clinical services, significant cost advantage, and our ability to speed up the clinical development.”

The goal is to submit an investigational new drug application to the U.S Food and Drug Administration,  targeting a Phase 2 trial in the United States starting early next year, he said.

A debilitating condition

Pruritus is a common condition that occurs simultaneously with chronic liver disease. It’s estimated that more than 2.5 million patients suffer from the “intractable and persistent” itch, causing insomnia, depression, and scratching that results in skin abrasions and bleeding.​

It also affects an estimated 11 million people suffering from atopic dermatitis, like eczema, and another four million in kidney disease.

No FDA-approved therapies are currently available for pruritis.

“Avior is striving to be the first to market,” said Vasisht.

Vasisht has a 20-year track record in the industry. Before starting up Avior, he served as chief technology officer with Biodelivery Sciences International, where he co-led the development and approval of three commercial products and helped raise $160 million in capital through equity, partnerships and debt financing.

Niraj Vasisht, founder and CEO of Avior Bio. — Avior Bio photo

He also worked as director at San Antonio-based Southwest Research Institute where he contributed to the early-stage development of nutraceuticals and a pharmaceutical.

In 2018, he retired to pursue his dream of starting his own company and developing new products with “big impact.”

“Encouraged by my friends and family, I set up exploring neurological ailments where I conducted most of my drug development work,” he recalled.

Interestingly, he first learned about pruritis — not from studying liver disease — but through a friend’s daughter suffering from refractory atopic dermatitis, meaning the condition is persistent and does not respond to treatment.

“Hoping to help her with existing drugs, I was surprised to learn that there was no approved therapy in the United States. Soon after I came up with a plan to develop the drug, and Avior was born.”

To date, Avior has raised $1.5 million through a dilutive pre-series A finance round through angel investors, friends and family. The North Carolina Biotechnology Center has also provided a $250,000 loan.

The startup has an office in Holly Springs with five employees. Vasisht said he’s also looking for a commercial place to set up a cGMP (current Good Manufacturing Practice) production facility in the Research Triangle. “We hope that this facility will be a fully integrated office and clinical manufacturing suite,” he said.​

The University of North Carolina Wilmington’s Yousry Sayed, Ph.D., president of Quality Chemical Laboratories, is one of Avior’s  angel investors. “If the data looks as good as the preclinical studies, the product will have tremendous positive implications in the 2.5 million suffering from pruritus-associated liver disease,” he said.

(c) North Carolina Biotechnology Center