Eli Lilly and Company Presents at Bernstein 2020 Operational Decisions Conference, Nov-16-2020 11:00 AM - NYSE:LLY

NYSE:LLY

**- Andrew Adams discussed bamlanivimab, a single-agent 700-milligram COVID antibody, and its combination with etesevimab.

• The combination therapy shows better reduction in viral load compared to the monotherapy, but both show equivalent effects on symptoms and hospitalization.

• The monotherapy may lead to treatment failures due to resistant variants, but these variants also appear in the placebo group.

• The combination therapy reduces the emergence of resistant variants, potentially leading to a longer-lasting treatment.

• Eli Lilly is considering second-generation antibodies with improved potency and half-life.

• The company is exploring the use of neutralizing antibodies for other viruses like dengue, Ebola, and HIV, but the high mutation rates of HIV and influenza make it challenging.

• Eli Lilly is also developing RNA-based therapies, including a collaboration with Dicerna for siRNA candidates in the cardiometabolic space.**

**- Jeffrey Emmick discussed the Phase III program for tirzepatide, aiming to replicate the A1c reduction and weight loss seen in Phase II trials with tolerability similar to pure GLP-1 receptor agonists.

• The Phase III program uses a slow stepwise dose escalation (2.5 mg every 4 weeks) to improve tolerability and reduce discontinuations.

• Tolerability in the 10 mg Phase II data was similar to Trulicity, and similar extended dose escalation algorithms have been used successfully with other GLP-1 receptor agonists.

• The SURPASS program will provide the first readout soon, with more readouts expected in the late first quarter and early second quarter of the following year.

• Hypoglycemia risk with tirzepatide is low, with no severe cases reported in Phase II studies and minimal occurrences when using the contemporary definition (plasma glucose <54 mg/dL).

• For obesity, the SURMOUNT 1 trial, evaluating the same doses as the diabetes program, completed enrollment in October 2020.

• Three additional SURMOUNT studies will start next year, evaluating weight loss in a broader population, including patients with and without diabetes.

• The SURPASS cardiovascular outcome trial, initiated in June, will compare tirzepatide to Trulicity for both noninferiority and superiority.

• A Phase II study in NASH is ongoing, with plans for a Phase III study if results are positive.

• Jeffrey Emmick noted the potential for tirzepatide to impact ectopic fat accumulation in the liver and improve insulin sensitivity independently of weight loss.**