April 14, 2021
1 min learn
Holcombe is CEO of vTv Therapeutics. Valcarce is chief scientific officer of vTv Therapeutics.
The FDA granted breakthrough remedy designation for TTP399 as an adjunctive remedy to insulin for the remedy of kind 1 diabetes, in line with a press launch from vTv Therapeutics.
TTP399 is an investigational oral, once-daily glucokinase activator. Breakthrough remedy designation relies on FDA’s willpower that preliminary scientific proof signifies that an investigational remedy could display substantial enchancment on a number of vital endpoints relative to obtainable therapies for a severe or life-threatening situation. As soon as granted, breakthrough remedy designation offers a sponsor with added assist and the potential to expedite growth and evaluation timelines for a promising new investigational medication.
“This FDA breakthrough remedy designation is a crucial milestone within the growth of TTP399 for the remedy of kind 1 diabetes, a severe, life-threatening and lifelong situation impacting the day-to-day lives of greater than one million Individuals,” Steve Holcombe, CEO of vTv Therapeutics, stated within the launch. “Hypoglycemia stays a number one reason behind morbidity and potential mortality within the remedy of kind 1 diabetes. Affected person and prescriber worry of hypoglycemia usually precludes tight glycemic management, and this FDA designation highlights the potential of TTP399 to handle this severe unmet medical want. We look ahead to working with the FDA as we advance the event of TTP399, and specifically as we start pivotal trials later this yr.”
As Healio previously reported, findings from the section 2 Simplici-T1 trial demonstrated that TTP399, when added to optimized insulin remedy, was proven to cut back HbA1c amongst adults with kind 1 diabetes throughout a 12-week trial compared with placebo plus insulin. The tablet was related to a placebo-subtracted HbA1c discount of 0.32% at 12 weeks compared with placebo.
“This can be the primary adjunctive remedy that may assist individuals enhance their glycemic management with out rising the chance for hypoglycemia,” Carmen Valcarce, PhD, chief scientific officer of vTv Therapeutics, advised Healio in October when the findings had been offered. “Worry of hypoglycemia is what retains individuals from reaching their goal objectives. That’s the main take-home message.”
Extra findings from the Simplici-T1 trial confirmed that TTP399 demonstrated a positive security profile, with irregular ranges of serum or urine ketones detected much less steadily amongst individuals assigned TTP399 vs. placebo.