Blog: ALTIMMUNE, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – Marketscreener.com

Item 7.01 Regulation FD Disclosure

On September 14, 2022, Altimmune, Inc. (the “Company”) issued a press release
announcing results from its Phase 1b study of ALT-801 (pemvidutide) in subjects
with non-alcoholic fatty liver disease (NAFLD). The Company intends to host a
conference call and live webcast to discuss the results on September 14, 2022 at
8:30 a.m. E.T. The Company has made available a slide presentation to accompany
the call, a copy of which is being furnished as Exhibit 99.2 to this Current
Report on Form 8-K.

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached
hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liabilities of
that section, nor shall they be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended, except as expressly set forth by
specific reference in such a filing. The Company undertakes no obligation to
update, supplement or amend the materials attached hereto as Exhibit 99.2.

Item 8.01 Other Events

On September 14, 2022, the Company announced results from a 12-week, Phase 1b
study of pemvidutide (proposed INN, formerly known as ALT-801), an
investigational glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist.

The trial was a randomized, double-blind, placebo-controlled study, with Dr.
Stephen A. Harrison, Medical Director, Pinnacle Research, serving as the
Principal Investigator. Ninety-four (94) subjects were randomized 1:1:1:1 to 1.2
mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 12 weeks. No
dose titration was used with 1.2 mg or 1.8 mg dose, while a short 4-week dose
titration was employed at the 2.4 mg dose. The primary efficacy endpoint was the
percent reduction in liver fat content from baseline, and the key secondary
efficacy endpoint was the percent weight loss from baseline. The trial was
conducted as a NAFLD clinical trial, and the dietary and exercise interventions
that are standard for obesity trials were not employed.

Subjects were randomized and treated at 13 sites across the U.S. Mean BMI at
baseline was 36 kg/m2 and mean liver fat content, as measured by MRI-PDFF, was
approximately 22%. Twenty-seven (29%) subjects had type 2 diabetes at baseline,
and approximately 75% of trial subjects were of Hispanic ethnicity.

The trial met its primary endpoint in all pemvidutide treatment groups. At the
1.8 mg dose (with and without diabetes), pemvidutide achieved a mean relative
reduction of liver fat content of 68.5%, with 94.4% of subjects achieving a 30%
reduction in liver fat, 72.2% achieving a 50% reduction in liver fat, and 55.6%
of subjects achieving normalization of liver fat, defined as liver fat fraction
of 5% or less. In addition, mean serum alanine aminotransferase (ALT) levels
declined in all subjects, and in subjects with baseline serum ALT above 30 IU/L,
levels declined more than 17 IU/L at all dose levels and 27.0 IU/L in the 2.4 mg
dose cohort.

The trial also met its key secondary endpoint in all pemvidutide treatment
groups. Employing an efficacy estimand, mean weight losses of 4.9%
(placebo-adjusted 4.7%) in subjects without diabetes and 4.4% in subjects with
diabetes (placebo-adjusted 3.9%) were achieved at the 1.8 and 2.4 mg doses,
respectively.

Pemvidutide was reported to be generally well tolerated. Gastrointestinal events
comprised the majority of the adverse events (AEs). Even without dose titration,
the symptoms experienced by subjects were predominantly mild and transient in
nature and consistent with known GLP-1 class effects. No serious or severe AEs
were reported. Two subjects treated with pemvidutide discontinued treatment due
to AEs [1 (4.3%) at 1.8 mg and 1 (4.2%) at 2.4 mg], both secondary to
gastrointestinal intolerability. No clinically significant ALT elevations
(defined as an increase to 3-fold or greater the upper limit of normal) were
observed. Glycemic control was unaffected, with no clinically meaningful changes
in HbA1c or fasting glucose. Clinically meaningful reductions in systolic blood
pressure were observed, along with the 2-3 beat per minute increase in heart
rate typical for GLP-1 class of drugs.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

No.     Description

99.1      Press Release of Altimmune, Inc. dated September 14, 2022

99.2      Slide Presentation of Altimmune, Inc. dated September 14, 2022

104     Cover Page Interactive Data File (embedded within the Inline XBRL document)

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