Anthrax vaccine (third generation) (Altimmune)

GAITHERSBURG, Md., May 08, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that members of the Company’s management team will participate and be available for 1x1 meetings at the following investor conferences: JMP Securities Life Sciences Conference in New York, NY Tuesday, May 16, 2023 Fireside chat at 9:00 am Eastern Time The session will be webcast and can be accessed by visiting the Events section of the Altimmune website. Piper Sandler Spring Biopharma Symposium in Boston, MA Thursday, May 18, 2023 One-on-one meetings only About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The Company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. For more information, please visit . Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on Twitter Altimmune Investor & Media Contact: Richard Eisenstadt Chief Financial Officer Phone: 240-654-1450 reisenstadt@altimmune.com

Shares in Altimmune fell over 53% on Tuesday after mid-stage study data raised concerns over the safety of the company's experimental obesity drug pemvidutide. Results showed that compared to placebo, 10 times more participants who received the peptide-based GLP-1/glucagon dual receptor agonist at the highest dose discontinued treatment due to adverse events (AEs).The findings come from an interim analysis of the MOMENTUM trial, which is designed to evaluate three different doses of pemvidutide in approximately 320 non-diabetic subjects with obesity, or who are overweight and have at least one comorbidity. They were randomised to receive weekly pemvidutide at doses of 1.2mg, 1.8mg and 2.4mg or placebo. A pre-specified interim analysis was conducted after 160 participants completed 24 weeks of treatment.Those given pemvidutide 2.4mg achieved mean weight loss of 10.7% at 24 weeks, while the 1.2mg and 1.8mg cohorts saw respective weight decreases of 7.3% and 9.4%. About half of responders in the two higher dose arms achieved ≥10% weight loss, while roughly one-fifth of patients in these groups lost ≥15% of their weight at week 24. By comparison, patients in the placebo arm lost only 1% of their body weight over that time.The company noted there was also greater mean weight loss across all dose groups among those who weighed at least 115kg at baseline, a group that made up three-quarters of the analysis population. This included weight loss of 11.9% in the higher-dose arm. In addition, Altimmune highlighted "robust reductions" in serum lipids as well as waist circumference. It said there were also clinically meaningful declines in blood pressure, without meaningful increases in heart rate.Half of dropouts tied to GI effectsUpper gastrointestinal (GI) events such as nausea and vomiting comprised the majority of AEs. The company said they were typically mild-to-moderate in severity and dose-related. Results showed that 11 patients in the 2.4mg cohort, or 26.8%, discontinued treatment due to AEs, versus one patient in the placebo arm. There was one serious AE of nausea and vomiting requiring rehydration in the high-dose arm. Meanwhile, rates of lower GI events including diarrhoea and constipation were "notably low," Altimmune said. Approximately half of the withdrawals across the pemvidutide dose groups were attributed to GI side effects.The drugmaker noted that the discontinuations occurred "almost entirely" in the first 16 weeks of treatment, but unlike other incretin trials, the MOMENTUM study protocol did not allow for dose reductions due to intolerability. Fasting glucose levels also rose slightly after 24 weeks in both the mid- and high-dose groups, compared to baseline, but the change was not significant. "This AE profile was observed in the absence of dose titration at the 1.2mg and 1.8mg doses and with a limited four-week dose titration at the 2.4mg dose," the company noted.CEO Vipin Garg suggested that the low- and mid-dose pemvidutide groups "used without dose titration would be attractive options for primary care physicians," adding "we have the opportunity to improve further upon the profile…by utilising higher doses in patients with more severe degrees of obesity, by allowing dose reduction and by employing a more prolonged titration for doses higher than 1.8mg in our future trials."Altimmune also conducted a 12-week Phase Ib trial to assess the safety profile of weekly pemvidutide in 54 overweight or obese subjects with type 2 diabetes. The company said glucose homeostasis was maintained throughout, with no significant changes in fasting glucose or HbA1c and no hyperglycaemic AEs. Rates of GI AEs were low, and there were no serious AEs with pemvidutide or AEs leading to study discontinuation.Garg said the 48-week MOMENTUM trial is slated to complete in the fourth quarter and that the company is initiating a Phase II biopsy trial of the drug in nonalcoholic steatohepatitis (NASH) in mid-2023.