LIR Life Sciences (CSE: SKNY; OTCPK: BBCMF) has announced that it has entered into a services agreement with closely held Oxygen Handel GmbH (OH), a specialized preclinical and regulatory development organization, to initiate Phase 0 strategic development planning for the company’s transdermal metabolic therapeutics pipeline.
Under the agreement, OH will conduct an FDA-focused regulatory and development roadmap designed to evaluate the optimal approval pathway for LIR’s transdermal GLP-1 and GLP/GIP-based therapeutic candidates, including assessment of potential 505(b)(2) regulatory pathways, bridging strategies to existing approved molecules, formulation development requirements, and preclinical and clinical study sequencing.
In a statement, Edward Mills, CEO of LIR, commented, “This agreement is an important operational milestone for us. As our pipeline continues to expand beyond individual molecules into a broad transdermal delivery platform, it becomes increasingly important to establish a clear and efficient regulatory and preclinical roadmap. We view this as the foundation for systematic advancement of multiple product candidates.”
