September 26, 2026 – Aspartes Pharmaceuticals Announces Completion of Phase 1 Clinical Study Evaluating ASP-001 ODT Formulations.
September 26, 2026 – Aspartes Pharmaceuticals Announces Completion of Phase 1 Clinical Study Evaluating ASP-001 ODT Formulations.
Denny Medjedovic founded Aspartes Pharmaceuticals in 2023 and serves as its Chief Executive Officer. Since its founding, Aspartes has focused on developing therapies for serious pediatric and rare neurological diseases with high unmet need.
Denny leads the company’s strategic direction. In early 2025, Aspartes began developing ASP-001, a novel pediatric orally disintegrating tablet formulation of flunarizine for the treatment of alternating hemiplegia of childhood (AHC). Under his leadership, the program has advanced through early research and development, formulation and clinical development activities, completion of a Phase 1 clinical trial, and early interactions with regulatory agencies. He works closely with clinicians, researchers, patient advocates, and development partners to guide the program and address the significant unmet need faced by patients and families living with AHC.
Denny studied Pharmaceutical Chemistry at the University of Toronto before leaving the program at age 17 to start Aspartes.
Harish K. Pimplaskar, MS, MBA, is Senior Vice President, CMC at Aspartes Pharmaceuticals and a seasoned pharmaceutical executive with more than three decades of leadership across drug development, manufacturing, regulatory strategy, and CDMO oversight.
Harish has played pivotal roles in advancing multiple programs through INDs, IMPDs, NDA submissions, and regulatory approval, including leadership on Cardamyst® at Milestone Pharmaceuticals and Northera® at Chelsea Therapeutics. Across his career, he has overseen complex CMC operations, technology transfer, CDMO partnerships, and product development initiatives spanning specialty and orphan indications. Widely recognized for his depth of expertise in pharmaceutical sciences and development, Mr. Pimplaskar has also authored numerous publications, holds multiple patents, and brings experience from leadership roles at Axsome Therapeutics, Upsher-Smith Laboratories, Pfizer Consumer Health, and MDRNA.
Harish holds a Bachelor of Pharmacy degree from University of Pune, M.S. degree in Pharmaceutics from the University of Rhode Island, and a Master of Business Administration degree from Averett University.
Paul Glidden previously served as Vice President of Manufacturing (CMC) at Zogenix (formerly Modis Therapeutics) and subsequently supported new product development at UCB during the post‑acquisition transition. At Modis/Zogenix, he led the development of Kygevvi™ for thymidine kinase 2 deficiency, an ultra‑rare genetic disorder, culminating in FDA approval in 2026 and a positive CHMP opinion in 2025.
Paul is a cofounder of La Jolla NanoMedical and BioVascular and has held Vice President–level development roles at those companies and at Angiosyn, with responsibility for early clinical development, nonclinical programs, manufacturing, and quality. His work has spanned multiple therapeutic areas, including oncology, vascular disease, hematology, and ophthalmology. Earlier in his career, he served as Director of Pharmacology and Toxicology at ISTA Pharmaceuticals, contributing to the approval of three drug products, and began his career at Alpha Therapeutic Corporation supporting cardiovascular and hematologic therapies.
Paul holds a B.S. in Biochemistry and Biophysics from Oregon State University and a Ph.D. in Pharmacology and Toxicology from the University of California, Irvine.
