Allegro Ophthalmics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to commence two Phase II clinical studies of integrin peptide therapy ALG-1001.
The new trials, which will be the fifth and sixth studies of ALG-1001, will be carried out in patients with wet age-related macular degeneration (wet AMD) and symptomatic vitreomacular traction (VMT).
The company had already completed two Phase I studies of ALG-1001 including one monotherapy study in each of diabetic macular edema (DME) and wet AMD.
Allegro Ophthalmics co-founder and chief technical officer Vicken Karageozian said the FDA approval validates the company's preclinical data, multiple Phase I study results as well as Phase II clinical study design.
"In just over three years, we've rapidly and methodically gone from compound discovery to Phase II clinical trials," Karageozian said.
"We are optimistic that this drug will continue to show efficacy and provide meaningful therapeutic benefit to patients with vascular eye diseases such as wet AMD and VMT."
Two Phase Ib/IIa studies are currently in progress, with one being a combination study in DME.
So far, all data secured from studies both in human and animals, showed that integrin peptide therapy is safe, well-tolerated and efficacious.
ALG-1001 mainly target integrins which play a major role in cell signalling and regulating cellular shape, motility as well as the cell cycle.
