- Amplia Therapeutics’ (ATX) pre-investigational new drug (IND) interaction with the US Food and Drug Administration is given the green light
- The company sought the FDA’s feedback on the design of its planned clinical study of its AMP945 treatment for first-line patients with advanced pancreatic cancer
- The FDA advised Amplia the design of the trial is generally acceptable, including selection of the first-line patient population
- Amplia has already secured an orphan drug designation from the FDA covering the use of AMP945 in the treatment of patients with pancreatic cancer which grants seven years exclusivity and a waiver of FDA fees
- Amplia Therapeutics last traded at 12 cents
Amplia Therapeutics’ (ATX) pre-investigational new drug (IND) interaction with the US Food and Drug Administration has been given the green light.
Amplia requested a pre-IND meeting to discuss the company’s proposed development plans with the division of oncologic diseases for its focal adhesion kinase inhibitor, AMP945.
The company sought the FDA’s feedback on the design of its planned clinical study of the treatment for first-line patients with advanced pancreatic cancer, which was scheduled to commence recruitment in the current quarter.
The FDA advised Amplia the design of its trial is generally acceptable, including selection of the first-line patient population.
It also confirmed Amplia’s understanding that dose selection for the two-stage expansion phase of the trial should be based on a combined view of safety, efficacy and pharmacodynamics across a wide range of doses.
However, the FDA did recommend further pharmacokinetic sampling to interrogate patient exposures more thoroughly to AMP945, gemcitabine and nab-paclitaxel.
Despite the setback, Amplia said the recommendation could be readily applied without delaying the trial.
Overall, the FDA dubbed Amplia’s pre-clinical data supportive of both the trial and a future marketing application in the proposed indication.
Amplia’s CEO and Managing Director Dr John Lambert said the company was pleased to receive FDA’s timely and helpful feedback.
“This pre-IND advice provides early insight into FDA’s priorities and equips us to address these proactively,” Dr Lambert said.
“It also allows us to enter our planned clinical study reassured that our intent to bring first-line patients into the trial is reasonable and acceptable.”
Amplia has already secured an orphan drug designation from the FDA covering the use of AMP945 in the treatment of patients with pancreatic cancer which grants seven years exclusivity and a waiver of FDA fees.
Amplia Therapeutics last traded at 12 cents at 12:52 pm AEST.