FDA Clearance Received for
Trial to Begin
Insignis Therapeutics and HLK Pharmacin Receive FDA IND Clearance to Initiate a Phase 1 Trial With IN-001 for Oral Anaphylaxis Treatment
Trial to initiate this quarter with data anticipated in 2021
Insignis Therapeutics (“Insignis”), a biotech company focused on developing innovative therapeutics for anaphylaxis treatment and HLK Pharmacin, a global drug development company, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IN-001, an oral formulation of an epinephrine prodrug for life-saving treatment of allergic reactions, including anaphylaxis. Under this IND, Insignis in collaboration with its strategic partner, HLK Pharmacin, is prepared to initiate a Phase 1 study with IN-001 (known as HLK-0006 within HLK Pharmacin) and intends to have clinical data in first half of 2021.
The Phase 1 single dose study in healthy volunteers will compare IN-001 orally dissolving tablet (epinephrine prodrug) vs the current standard of care, EPIPEN (epinephrine injection). If successful, under the 505(b)(2) regulatory pathway, Insignis and HLK Pharmacin would begin preparations to initiate a pivotal study in the second half of 2021.
“The FDA clearance of our IND represents an important milestone for Insignis and our strategic partner HLK Pharmacin as we advance the development of IN-001 to provide people living with severe allergies an oral prodrug version of epinephrine for life-threatening emergencies such as when anaphylaxis strikes,” commented Mingbao Zhang, PhD, Chief Executive Officer and Founder of Insignis Therapeutics. “The global anaphylaxis injectable epinephrine market is a multi-billion dollar opportunity that is continuing to grow with the increase in prevalence and incidence of anaphylaxis. We believe that IN-001 has the potential to provide patients with a more discreet, convenient and fast acting alternative to current emergency injectable treatment options.”