Okogen, Inc., a clinical-stage biotechnology company focused on developing innovative therapies for infectious diseases, today announced that the Central Drugs Standard Control Organisation (CDSCO), India's national drug regulatory authority, has authorized the EMERALD study, the Company's Phase 1/2 clinical trial evaluating Treyegen™ (OKG-0303) for the treatment of acute infectious conjunctivitis.
The authorization is a significant milestone in the development of Treyegen™ (OKG-0303) and transitions the program into clinical evaluation. The approved EMERALD study follows years of formulation development, manufacturing, nonclinical research and regulatory engagement, establishing the pathway to generate the clinical data required to support future regulatory and commercial development.
"Every successful development program is defined by a series of execution milestones that increase the probability of success and build greater value," said Joshua Moriarty, Chief Executive Officer of Okogen. "Receiving CDSCO authorization is among the most significant milestones achieved by Treyegen™ (OKG-0303) since the program was conceived and reflects years of disciplined execution across our scientific, manufacturing, clinical and regulatory organizations.”
Treyegen™ (OKG-0303) is being developed as a novel ophthalmic therapy designed specifically for both the viral and bacterial forms of acute infectious conjunctivitis. Unlike conventional approaches directed toward presumed viral disease, presumed bacterial disease or symptomatic management alone, Treyegen™ (OKG-0303) combines antiviral, antibacterial and symptom-relieving activities in a single investigational therapy addressing the disease's broad clinical presentation. The EMERALD Phase 1/2 study is expected to generate one of the most comprehensive clinical datasets assembled for an investigational therapy in acute infectious conjunctivitis, including evaluations of safety, systemic pharmacokinetics, virologic and microbiologic activity, and clinical efficacy. The program will enroll more than 300 patients, with data expected later this year.
"Our objective has never been simply to develop another ophthalmic anti-infective," Moriarty added. "We set out to develop a therapy designed for the way acute infectious conjunctivitis is actually encountered in clinical practice, where physicians often need to make treatment decisions before the underlying cause has been definitively established. We believe that complexity makes it one of the most challenging infectious diseases in ophthalmology, but it also makes it an ideal proving ground for our host-directed antiviral platform. If we can demonstrate meaningful clinical benefit across this diverse disease state, we believe it has important implications well beyond ophthalmology."
India represents an ideal environment for the clinical evaluation of acute infectious conjunctivitis given its high disease burden, internationally recognized ophthalmic investigators and extensive clinical research infrastructure. The EMERALD study will be conducted at leading ophthalmic centers across the country including the Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi.
"Acute infectious conjunctivitis is uniquely challenging because it encompasses a broad range of viral and bacterial pathogens that often cannot be distinguished at initial presentation. That complexity makes it an ideal disease in which to evaluate a therapy designed to address the broad clinical presentation of infection rather than a single organism. Success in this setting would provide important validation of both Treyegen™ (OKG-0303) and the broader therapeutic potential of the ranpirnase platform," said David A. Hollander, MD, MBA, Chief Medical Officer of Okogen. "The breadth of data generated through the EMERALD study will help guide future development decisions while further defining the clinical profile of Treyegen™ (OKG-0303). We appreciate the rigorous scientific review conducted by CDSCO and look forward to advancing this program."
Okogen expects to begin enrolling subjects in the EMERALD study in the coming weeks and intends to provide additional updates as the clinical program reaches key development milestones.
Okogen also recently launched its new corporate website at www.okogen.com. The website reflects the Company's focus on its host-directed antiviral platform and provides updated information on Treyegen™ (OKG-0303) and the Company's development programs.
About Treyegen™ (OKG-0303)
Treyegen™ (OKG-0303) is an investigational ophthalmic therapy being developed for the treatment of acute infectious conjunctivitis. The proprietary formulation combines ranpirnase, a host-directed antiviral, tobramycin, a broad-spectrum antibacterial agent, and oxymetazoline, which reduces ocular redness, into a single investigational therapy designed to address the broad clinical presentation of acute infectious conjunctivitis. Okogen believes this differentiated approach has the potential to simplify treatment decisions while providing physicians with a comprehensive therapeutic option for patients presenting with acute infectious conjunctivitis.
About Okogen
Okogen, Inc. is a clinical-stage biotechnology company developing a broad-spectrum, host-directed antiviral platform built around ranpirnase. The Company is advancing ranpirnase-based therapies across four therapeutic pillars: ophthalmology, medical countermeasures, systemic antivirals and dermatology. Its development strategy positions ophthalmology as the lead clinical proving ground for the platform, with the goal of applying clinical insights, formulation expertise and manufacturing capabilities across a broader portfolio of antiviral therapies. For more information, visit www.okogen.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the development, clinical evaluation, regulatory progress, potential benefits and commercialization of Treyegen™ (OKG-0303). These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Okogen undertakes no obligation to update any forward-looking statements except as required by applicable law.
SOURCE: Okogen
