Adocia 2Q16 – Strategic commitment to focus exclusively on diabetes; Phase 1b results for HinsBet human insulin expected in 3Q16; Results from phase 1b pump study of BioChaperone Lispro expected in 4Q16 – July 21, 2016

Adocia provided its 2Q16 update via press release this morning. Reported below are our top five highlights from the update.

1. Adocia reiterated its strategic decision to commit itself exclusively to diabetes therapy, launching a new BioChaperone Glucagon project and discontinuing its non-diabetes projects.

2. Adocia highlighted the announcement of positive results from three trials of its Lilly-partnered ultra-rapid-acting BioChaperone Lispro vs. Lilly’s Humalog (insulin lispro). Results from a phase 1b pump study of BioChaperone Lispro are expected in 4Q16.

3. Adocia expects to initiate a clinical trial of BioChaperone Combo (insulin glargine/insulin lispro) in 3Q16.    

4. Adocia shared that results are expected in 3Q16 from a phase 1b study of HinsBet (BioChaperone human insulin) and a phase 3 study of BioChaperone PDGF-BB, a wound-healing project for diabetic foot ulcers.

5. Adocia had cash and cash equivalents of €61 million (~$68.9 million) as of June 30, down from €64.2 million (~$73.1 million) in 1Q16 and €72.8 million (~$81 million) in 2Q15.

Top Five Highlights

1. Adocia reiterated its strategic decision to commit itself exclusively to diabetes therapy. The company announced in June that it would discontinue its non-diabetes programs and launch an exciting new BioChaperone Glucagon project, which is slated to begin clinical trials in 1H17. Adocia cited the strong potential for growth and rich opportunities in the diabetes market as the reason for this transition, and we couldn’t be more enthusiastic about their renewed commitment to this field, despite the increasingly high bar for new diabetes therapies.

2. Adocia highlighted the announcement of positive results from three trials of its Lilly-partnered ultra-rapid-acting BioChaperone Lispro vs. Lilly’s Humalog (insulin lispro). These include: (i) full results from a phase 1b study (n=38) presented at this year’s ADA demonstrating superior postprandial control with BioChaperone Lispro compared to Humalog in patients with type 1 diabetes (a 42 mg/dl PPG difference at one hour and a 27 mg/dl PPG difference at two hours); (ii) topline results from a second phase 1b study (n=50) demonstrating similar improvements in postprandial control with BioChaperone Lispro over Humalog in patients with type 2 diabetes; and (iii) topline results from a phase 1 study (n=15) suggesting an accelerated PK/PD profile for BioChaperone Lispro compared to Humalog in healthy Japanese subjects under euglycemic clamp.

• Results from an ongoing phase 1b trial in patients using BioChaperone Lispro in an insulin pump are expected in 4Q16. The trial (n=80) includes two parts. Part A involves a 14-day crossover trial (n=36) evaluating postprandial control and a variety of PK/PD parameters vs. Humalog in pumps in patients with type 1 diabetes. Part B (n=44) will evaluate PK/PD, pump compatibility, and safety of BioChaperone Combo vs. Humalog administered via two different pumps (Roche’s Accu-Chek Spirit and Medtronic Paradigm Veo) and administered via syringe in a four-period crossover study. The trial is expected to complete in October 2016.

3. Adocia expects to initiate a clinical trial of BioChaperone Combo (insulin glargine/insulin lispro) in 3Q16.  This is a slight delay from the 2Q16 expected launch of the trial reported in the company’s 1Q16 update. Adocia previously stated that it planned to launch two clinical studies of BioChaperone Combo and we are curious whether a second trial will be launched later. Adocia presented promising results for BioChaperone Combo at this year’s ADA  demonstrating that the product produced lower post-meal glucose peaks (72 mg/dl vs. 95 mg/dl) and reduced postprandial glucose excursions at one hour (-24 mg/dl) compared to Lilly’s Humalog in a double-blind, randomized, crossover mixed-meal study (n=28). If the upcoming study is positive, we are curious whether this product could eventually be included in the Lilly partnership as well. Adocia has previously noted that the results of this upcoming study, if positive, are intended to inform the design of a phase 3 clinical program.

4. Adocia shared that results are expected in 3Q16 from a phase 1b study of HinsBet (BioChaperone human insulin) and a phase 3 study of BioChaperone PDGF-BB, a wound-healing project for diabetic foot ulcers. The HinsBet study (n=36) is a randomized, double-blind, three-treatment, three-period cross-over trial comparing the effectiveness of HinsBet on post-meal glycemic control versus Lilly’s Humulin (human insulin) and Humalog (insulin lispro). The study is expected to complete in August 2016, according to ClinicalTrials.gov. The BioChaperone PDGF-BB study (n=252) in India is a multicenter, randomized, parallel group, double blind trial comparing the effectiveness of BioChaperone PDGF-BB on foot ulcer wound closure, vs. the standard of care saline solution. It’s unclear if and when this trial completed, as it is still listed as recruiting with an expected completion date of December 2015 on ClinicalTrials.gov.

5. Adocia had cash and cash equivalents of €60.9 million (~$68.9 million) as of June 30, down from €64.2 million (~$73.1 million) in 1Q16 and €72.8 million (~$81 million) in 2Q15. This reflects Adocia’s ongoing investment in the clinical development of its many pipeline projects. Since 2Q15, the company reports a 70% increase in operating expenses, 81% of which were dedicated to R&D.

-- by Abigail Dove, Helen Gao, Emily Regier, and Kelly Close