Celestial Therapeutics Receives NIAID, NIH SBIR Fast Track PH II Grant
Image courtesy of NIAID
Celestial Therapeutics Inc. (“Celestial”), an innovative IND stage biotechnology company developing next-generation mRNA vaccines and groundbreaking dual modal broad-spectrum antiviral/anti-inflammatory therapeutics to treat, prevent and cure infectious diseases, inflammatory conditions and cancers, is pleased to announce that it has been awarded a Phase II fast track SBIR grant from the National Institutes of Health’s (NIH’s) National Institute of Allergy and Infectious Diseases (NIAID). The grant, valued up to $1,643,140, will provide non-dilutive funding for the development of a novel dry powder inhalation therapeutic, CT-02, based on Celestial’s proprietary lipid platform for the treatment and prevention of Respiratory Syncytial Virus (RSV) infections.
The first phase of the grant award, which totaled $290,117, has been successfully completed. A final report was submitted to NIH and the project was approved to proceed to Phase II. The Phase I study found CT-02 to be much safer and more effective against RSV infections when administered via inhalation as a dry powder therapeutic at significantly lower doses than Ribavirin which was used as a positive control. CT-02 demonstrated potent anti-inflammatory action in addition to its antiviral action, while exhibiting both preventive and therapeutic effects. CT-02 significantly reduced the RSV viral load in cotton rats which are the gold standard for evaluating antiviral activity against RSV. In addition, CT-02 led to a significant decrease in inflammation in the larynx, trachea and lungs of infected cotton rats, whereas, Ribavirin did not lower inflammation in cotton rats infected with RSV. This data clearly demonstrated superior safety and efficacy of CT-02 for the treatment of RSV infections as compared to Ribavirin which is the only approved antiviral currently on the market for the treatment of RSV infections in high-risk infants and immunocompromised patients. Ribavirin has limited efficacy and serious toxicity issues and is typically administered as a continuous aerosol over 12 to 18 hours per day for 3 to 7 days. Per Verified Market Reports: (https://www.verifiedmarketreports.com/product/ribavirin-market/), Ribavirin market size was valued at USD 1.5 Billion in 2024 and is forecasted to grow at a Compounded Annual Growth Rate (CAGR) of 4.2% from 2026 to 2033, reaching USD 2.1 Billion by 2033.
Having safe and effective therapeutics for the treatment and prevention of RSV infections for all age groups remains an unmet need. Even though, prophylactic monoclonal antibodies (mAbs) against RSV namely, Palivizumab and Nirsevimab have been approved for prophylactic therapy for newborns and infants, these mAbs have not been approved for older people and are not suitable for therapeutic intervention for the treatment of RSV once an active infection has been established. Similarly, RSV vaccines namely, Abrysvo and Arexvy which have been approved for adults >60 years of age, are prophylactic and are not suitable for intervention once an active infection has been established. Human RSV infections have an estimated global incidence of 33 million cases in children younger than 5 years with up to 234,000 dying of the disease each year. Although often characterized as a pediatric disease, RSV infection in adults aged 65 years or older represent a substantial health burden. Failures of late-phase trials for vaccines and therapies based on mAbs underscore the need to develop novel interventions for RSV. To address this urgent medical need, Celestial is developing an innovative therapeutic that has the potential for prophylaxis and treatment of RSV and other viral infections in all age groups worldwide.
Dr. Ajay Gupta, Celestial’s CEO states “There is a huge unmet medical need to develop safe and effective products for the prevention and treatment of respiratory infections. Our novel therapeutic product is not only an effective broad spectrum antiviral agent but also a potent anti-inflammatory while serving as both a prophylactic and a therapeutic. We are very excited about securing this Phase II non-dilutive funding from NIAID/NIH as it supports our mission, science, innovation and our product development strategy. This funding will help us to complete some of the IND-enabling studies on a non-dilutive basis and will enable us to advance this program towards human clinical trials”.
About Celestial Therapeutics
Celestial Therapeutics is developing novel and groundbreaking anti-viral/anti-inflammatory therapeutics and mRNA vaccines/therapeutics to treat, prevent and cure infectious diseases, inflammatory conditions and cancers. Celestial’s mission is to effectively treat respiratory viral infections & inflammation, cancers, save lives, reduce healthcare costs and address unmet medical needs. Founded in 2019, Celestial has rapidly built a diverse portfolio based on innovative innate immunity platform technologies. Celestial’s lead therapeutic, CT-02 is a first-in-class of a new class of broad spectrum anti-infective/anti-inflammatory drugs initially being developed for the treatment of Respiratory Syncytial Virus. Celestial is also developing next generation mRNA vaccines and therapeutics for a variety of indications based on its novel and proprietary mRNA platform. The Celestial team consists of industry veterans and prominent academicians with a proven track record.
To learn more, visit https://www.celestialtherapeutics.com
Contacts:
Celestial Therapeutics
Leontis Teryazos - CFO