Biotech vTv believes small molecule GLP-1 pill can take on big players

US biotech vTv Therapeutics was showcasing mid-stage trial results from its oral small molecule GLP-1 pill at this year's American Diabetes Association conference, as it searches for partners to fund further development.

In an interview with pharmaphorum, Carmen Valcarce, chief scientific officer at the North Carolina biotech said things are stacking up well for the drug known as TTP273, based on stage 2 data presented at the conference in San Diego.

The hope is that TTP273 could be developed into a pill to rival Novo Nordisk’s late-stage oral formulation of its semaglutide GLP-1, with the advantage of lower risk of gastrointestinal side-effects.

TTP273 already met efficacy endpoints, improving glycaemic control compared with placebo in phase 2, but vTv needs a late stage trial to confirm data about efficacy, safety and side-effects– something that it does not have the financial muscle to fund.

Valcarce said the small molecule nature of TTP273 makes it ideal for an oral formulation. Novo Nordisk’s next generation GLP-1 semaglutide is a larger peptide-based drug, which is more difficult to absorb through the gut.

Phase 2 trial results from oral semaglutide showed 13% of low-dose patients had nausea, with 37% at a high dose.

Nausea occurred in 6% and 24% in the low and high dose groups respectively, while diarrhoea occurred in 7% and 23% of patients in low and high dose respectively, according to phase 2 trial results from oral semaglutide reported at last year’s ENDO conference.

Meanwhile results from vTv’s LOGRA study of TTP273 showed 3.4% of 59 patients in an afternoon dosing schedule cohort experienced nausea, with rates of 5% in a 60-patient twice-daily dosing schedule arm. There were no cases of vomiting in either arm.

There were also lower rates of diarrhoea on LOGRA, occurring in 3.4% and 11.7% in the afternoon dose and twice daily dose groups respectively.

Valcarce said: “We are not seeing nausea and vomiting, which is a problem with some of the other (GLP-1s)”.

She was cagey about which companies vTv has approached, although she suggested that Novo Nordisk may be too preoccupied with development of semaglutide to consider a partnership.

Another goal is to work out the best dosing schedule – TTP273 has already been tested as a twice daily or daily treatment, but could be developed as a longer-acting treatment with already-available pill technology, Valcarce said.

“We started talking to people earlier this year when we saw the results from the phase 2 study, but it is a time consuming process.”

“It could be good for [companies] already in diabetes, but for those who want to be in diabetes this would an excellent programme – we are talking to everybody.”