AyuVis Research, Inc., a six-year-old Fort Worth biotech startup and TechFW incubator client, said Monday it won a special designation from the federal Food and Drug Administration for a drug it’s developing to prevent chronic lung disease in prematurely born babies.
The FDA gives “Orphan Drug Designation” to drugs and biologics – products made from natural sources – produced for the treatment, prevention or diagnosis of rare diseases and conditions that affect fewer than 200,000 people in the United States.
The designation creates financial incentives such as partial tax credit for clinical trial expenses, waiver of $2.2 million new drug application fee, and eligibility for seven years of marketing exclusivity beyond the time provided by a strong patent, AyuVis said.
The company said the FDA awarded it the Orphan Drug Designation for AyuVis’ drug AVR-48 for the prevention of bronchopulmonary dysplasia.
BPD can lead to long-term respiratory, psychological disabilities, and death.
Babies with BPD require ventilators or other supplemental oxygen, but those treatments damage their lungs and release substances that cause inflammation and tissue damage, AyuVis said.
AVR-48 works to modify the immune system by decreasing the inflammatory response and preventing development of BPD, “which should result in lives being saved, improvement in the quality of life of survivors and reduced hospital costs,” AyuVis said.
“We are very excited and encouraged that the FDA approved AVR-48 for a condition that has a huge medical need globally,” said Suchismita Acharya, PhD, CEO of AyuVis, which she founded in 2014.
“The recognition by the FDA is validation of our science and will facilitate our strategic partnership discussions. The designation also can mark young companies as preferable to investors because it might be expected to have reduced competition. This is great motivation to our extraordinarily talented scientific, clinical and business team to march toward our goal to the clinic and beyond.”
AyuVis said it plans its first-in-human Phase 1 clinical trial in 2021. To reach the marketplace, AyuVis will produce AVR-48 for clinical trials, finish pre-clinical studies, and conduct Phases 1, 2a and 2b clinical trials, AyuVis said.
“With positive clinical results, there is the opportunity to receive Accelerated Approval from the FDA, which could preclude a Phase 3 trial.”Acharya started AyuVis on a search for solutions to antibiotic resistance to drugs and target clinical needs in serious and life-threatening indications.
Before AyuVis, Acharya spent 11 years at Alcon Labs and led projects from early discovery to pre-clinical and clinical stages of development in diseases such as glaucoma, age-related Macular Degeneration, and viral conjunctivitis.
The AyuVis team includes David Riley, M.D., MBA, chief medical officer; Keith Bryant, MBA; Dale Christensen, PhD, is director of early development; Russell Bromley, director of operations; Stella Robertson, PhD, drug development advisor; Ranjan Misra, business advisor, and Darlene Boudreaux, CFO.