Hyderabad: Indian Institute of Chemical Technology (IICT) has transferred an IND-ready phytopharmaceutical technology, developed from ‘Gymnema sylvestre’, for treating diabetic foot ulcers to a private firm, moving the botanical formulation towards regulatory submissions and clinical evaluation in India and the US.‘Gymnema sylvestre’ is commonly called ‘Gurmar’ or ‘Gudmar’ in Hindi, which means “sugar destroyer”. In Telugu, it is called ‘Podapatri’.Under the technology transfer agreement, the private firm, Viridis Biopharma Pvt Ltd, would take up the next phase of development, including submissions to Central Drugs Standard Control Organization (CDSCO) and US Food and Drug Administration (FDA).The technology, developed by researchers of IICT’s department of applied biology under the leadership of Dr Anthony Addlagatta, also has potential applications in other chronic wounds and inflammatory skin disorders. IND-ready means a drug candidate or research compound has completed all necessary preclinical laboratory and animal testing, manufacturing assessments, and documentation.From Gymnema to IND-ready formulationThe programme was supported under the CSIR Phytopharmaceutical Mission Phase-III, aimed at translating scientifically validated botanical products into therapies with potential clinical use.According to IICT, the research has undergone botanical standardisation, pharmacological evaluation, mechanism-of-action studies, analytical characterisation, pharmacokinetic studies, formulation development, GMP process development, stability evaluation and GLP-compliant safety studies. The development has also resulted in patent protection in India and international jurisdictions.The studies together have generated what the institute described as a comprehensive IND-ready data package for the standardised botanical therapeutic.IICT director Srinivasa Reddy said the transfer was part of the institute’s efforts to move scientific research towards healthcare applications.“The successful development of this IND-ready phytopharmaceutical formulation highlights the strength of our scientific capabilities and our focus on evidence-based botanical drug discovery. We are delighted to continue our partnership with Viridis Biopharma to take this promising technology towards clinical development and global regulatory pathways, including USFDA,” he said.Viridis to take drug towards clinical evaluationCSIR and Viridis Biopharma have a long-standing association that began with a technology transfer from CSIR-IIIM, and the latest agreement extends that partnership.Viridis would now undertake regulatory development of the diabetic foot ulcer formulation, with the objective of advancing it into clinical evaluation.Viridis Biopharma director (Technical) Anslem de Souza said, “We are excited to be involved in the commercial development of this technology, which fulfils a gap in currently available treatment and is in line with Viridis’ portfolio for advanced wound management.”The agreement takes the publicly funded research through another stage of the development chain — from scientific discovery and intellectual property generation to technology transfer, regulatory development and proposed clinical evaluation.IICT said the programme was also part of its effort to build capabilities in phytopharmaceutical development, translational research, technology commercialisation and evidence-based botanical drug development.
