vTv recently provided its 2Q18 update via press release. The company reported $1.2 million in cash and cash equivalents as of June 30, down considerably from $6.5 million at the end of March 2018 and $32.5 million at the end of 2Q17. In our view, this is a concerning cash position and trajectory, though the company highlighted an additional $10 million capital line from MacAndrews & Forbes in its press release. During 2Q18, vTv terminated its phase 3 STEADFAST trial for azeliragon in mild Alzheimer’s due to a lack of efficacy – this is obviously extremely disappointing for the company and we hope this does not negatively impact the viability of vTv or its diabetes candidates. The company posted a net loss of $9.6 million in 2Q18, on par with a loss of $10.0 million in 1Q18.
vTv highlighted that phase 2 patient dosing has begun for the JDRF-sponsored phase 1/2 SimpliciT1 Study (n=126) of oral glucokinase activator TTP399, examining change in A1c at 12 weeks (expected completion January 2019). Preliminary phase 1 results (n=5) in this extremely small study were presented at ADA 2018, demonstrating that TTP399 was well-tolerated (no severe hypoglycemia or DKA), glycemic control was improved, and insulin bolus levels were reduced. The extremely small sample size precludes intense interpretation, but these results are nevertheless encouraging given increased buzz around adjunct therapy for type 1 diabetes and the massive unmet need.
Oral GLP-1 candidate TTP273 is in phase 2b development with Chinese company Huadong Medicine, which hopes to commercialize the product in China. To our knowledge, the trial – to be conducted in the US and China – has not yet been initiated or posted to ClinicalTrials.gov. TTP273 completed a phase 2 study in January 2017 (presented at EASD 2017), and this follow-up study is investigating the finding that lower doses of TTP273 might be more effective – which could mean a milder side-effect profile without compromised efficacy.
We’re excited about the prospect of multiple oral GLP-1 agonists coming to market: Novo Nordisk’s oral semaglutide is on track for a 2019 filing with FDA. As a small molecule, TTP273 could carry some interesting differences in terms of gut absorption and formulation, and we’re very much looking forward to more data. Two oral candidates should mean far more patients on GLP-1 agonists overall, and we see plenty of headroom for commercial success from both.
--by Martin Kurian, Ann Carracher, and Kelly Close