VTV Therapeutics 'Close To The Finish Line' On What FDA, Diabetes Patients Want: An Adjunct Therapy To Insulin

Steve Holcombe transitioned from telecom to biotech back when vTv Therapeutics Inc VTVT was just a startup. Now, 18 years in, he’s finally seeing the fruits of his labor.

“We’re getting close to the finish line,” Holcombe, the CEO of VTV, told Benzinga. “We’re getting close to a therapy that we think the FDA would like to see, that the patient population would like to see.”

VTV’s Lead Program

The therapy he refers to is VTV’s TTP339, an insulin-adjunct therapy for Type 1 diabetics. In mid-February, the company reported positive results from the drug’s Phase 2 trial.

TTP339 was initially designed for Type 2 diabetes, but after running a successful Phase 2 trial, VTV decided that the Type 2 market was too crowded and cost-competitive — and starting a Phase 3 trial would be expensive.

“We turned our attention to the Type 1 market, where all they have is insulin,” Holcombe said, noting a dearth of competition.

“In the past several years, the only advancements have been in technology — insulin pumps or continuous glucose monitors. Diabetic patients are looking for other therapies to take alongside insulin to get to target levels during the day.”

In the recent study, the drug met the FDA’s highest requirement for approval by lowering hemoglobin A1c levels. It also reduced the quantity of insulin patients were taking, kept patients in sweet-spot glucose levels longer and triggered no statistically significant rates of hypoglycemia or ketoacidosis — side effects that consistently trip up other diabetes programs.

VTV plans to coordinate with the FDA on registration trials in the next few months and hopes for feedback by the end of the second quarter. If all goes according to plan, Phase 3 trials will begin by the end of 2020.

“We have a unique opportunity because there are no approved adjunct therapies in the market today, so we could be the first there if we keep up the momentum,” Holcombe said. “We have what we think the agency is looking for.”

See Also: vTv Therapeutics Reports Positive Midstage Trial Results For Type 1 Diabetes Drug

Other VTV Programs

Apart from its core program in Type 1 diabetes, VTV is conducting a Phase 2 trial for dementia in patients with Type 2 diabetes.

The drug, Azeliragon, was initially designed to treat Alzheimer’s in all patients but failed to demonstrate effects distinct from those of the placebo. That program was discontinued in March 2018, but management salvaged the molecule. It spun off a new program in the more targeted patient group, which uniquely responded to the drug in the first study.

VTV will announce results from the Azeliragon trial in the first half of 2021.

VTV's Market Opportunities

Both of VTV’s leading programs boast large addressable markets. TTP399 could be marketed to 1.5 million Type 1 diabetics in the U.S. and 30 million worldwide. For Azeliragon, the number of dementia patients with diabetes tallies 20 million.

“We think they’re both multibillion-dollar opportunities,” Holcombe said, citing the specific opportunity in Type 1 diabetes. “We could be the first adjunct therapy to insulin in the U.S. Pricing for those would probably be comparable to what Type 2 [adjunct] oral therapies are out there — about $4,000 to $6,000 per year.”

Holcombe said that, after completing the current trials, VTV may try to expand its TTP399 patient population to young adults or teenagers. It might also examine other dementia-related indications for Azeliragon.

VTV's Finances, Partnerships

At this point, VTV has the financial resources to execute its plans, the CEO said. 

“We definitely don’t need capital,” Holcombe said. “We’ve been successfully raising capital for 18-plus years … I think we’ve got different mechanisms to advance this program by ourselves or with partners.”

VTV is unique in that it discovers its own small molecules, but it doesn’t go entirely solo. Management has a few collaborators for R&D, and it is seeking additional partnerships with pharmaceutical companies scaled for development and commercialization.

Holcombe said he “doesn’t envision growing a commercial organization.”

VTV's Policy Opportunities

VTV has some internal catalysts of its own coming up in the next few quarters, but it could also benefit from external activity. The insulin market has become a frequent target of politicians. Policymakers criticize pricing, reimbursement models and insurance coverage, and they have a huge platform in the coming presidential election.

“From a policy point of view, we think people would like to see some alternatives to insulin that can reduce the amount or be taken on top of [insulin doses],” Holcombe said.

VTV thinks it has the alternatives the nation is looking for.