Vical Presents Phase 1 VL-2397 Data at the June ASM Microbe 2017 Meeting Supporting Advancement to Phase 2
June 05 2017 - 6:30AM
Vical Incorporated (Nasdaq:VICL) announced that the company
presented clinical data from its completed first-in-human Phase 1
trial of its novel antifungal, VL-2397 at the American Society of
Microbiology (ASM) Microbe 2017 meeting in New Orleans. The results
indicate that VL-2397 appeared to be safe and well tolerated with
favorable plasma pharmacokinetic (PK) profiles in healthy subjects.
Vical is planning to initiate a Phase 2 trial in patients with
invasive aspergillosis in the fourth quarter of 2017.
Mammen “Anza” P. Mammen, Jr., M.D., Vical’s
Senior Vice President, Clinical Development, presented the poster,
“Phase 1 Safety and Pharmacokinetics Study of VL-2397, a Novel
Antifungal Agent.” The Phase 1 trial of VL-2397, was a randomized,
double-blind, placebo-controlled trial designed to evaluate
safety, tolerability and PK of single and multiple ascending doses
of intravenous VL-2397 in healthy volunteers. A total of 96
subjects ranging in age from 19 to 55 were enrolled into 11
cohorts; subjects completed all study visits.
Safety findings revealed neither
treatment-related serious adverse events nor Grade 4
Treatment-Emergent Adverse Events (TEAEs) at any dose. The most
common TEAEs were infusion site reactions. Dosing in two subjects
was discontinued after dose 2 in the highest once-daily (1200 mg)
dose cohort due to Grade 3 generalized rash (the only Grade 3 AE in
the trial) and Grade 1 creatinine elevation, respectively. VL-2397
appeared to be well tolerated up to the 1200 mg dose. The PK
analysis demonstrated low variability between subjects within a
cohort and between cohorts receiving the same dose. No VL-2397
accumulation was observed with any dose, including the final cohort
with dosing of 300 mg every 8 hours for 7 days followed by 600 mg
daily for 21 days.
“Invasive aspergillosis is a very serious fungal
infection involving the lungs and other organs in susceptible
hosts, and it is associated with a high mortality rate. Current
therapies can have toxicities and cause drug interactions, and
response rates are often suboptimal,” said Peter G. Pappas, M.D.,
F.A.C.P., Director of the Mycoses Study Group and Professor of
Medicine in the Division of Infectious Diseases and Department of
Medicine at the University of Alabama in Birmingham. “New treatment
options are urgently needed for these patients. The profile of
VL-2397 emerging from Phase 1 is encouraging, so if safety and
efficacy can be demonstrated in patients with invasive
aspergillosis in Phase 2, it could be very promising.”
Additionally, Laura Kovanda from Astellas Pharma
Inc. and the University of Liverpool presented the poster,
“Population Pharmacokinetic Modeling of VL-2397, a Novel Systemic
Antifungal Agent: Analysis of a Single and Multiple Dose Phase 1
Study.” The PK from single and multiple ascending dose cohorts in
the Phase 1 study of VL-2397 were combined to construct a
population PK model. A total of 1462 plasma samples from 64
subjects were included. The data indicate that VL-2397 has
non-linear saturable binding kinetics. Height was the only
covariate with a significant relationship to clearance. The PPK
model can be used to optimize dosing by bridging the kinetics to
efficacious pharmacodynamic targets.
VL-2397 was also featured in an oral
presentation and two additional poster presentations at the
conference. The abstracts are available through the conferences
online program planner:
- Sean Sullivan, Ph.D. Vical’s Senior Executive Director,
Pharmaceutical Sciences, will presented “Development of VL-2397 as
a Novel Antifungal Drug Candidate to Treat Invasive Aspergillosis,”
providing an overview of the product profile, lead indication,
preclinical data and the Phase 1 trial. The slides presented by Dr.
Sullivan will be made available on Vical’s website.
- Dr. Sullivan also presented the poster, “Characterization of
Potential Drug Interactions and Off-Target Activities of VL-2397, a
Novel Antifungal Agent against Invasive Aspergillosis.” Results of
these studies suggest that VL-2397 has a low propensity for
drug-drug interactions because it does not tend to exert a
time-dependent inhibitory effect on the CYP isozymes tested, and at
the drug exposure levels tested, appears to have a very low
potential for off-target activity with a variety of cellular
proteins. This is consistent with VL-2397’s novel Sit1-dependent
mechanism of action and suggest it may provide an effective
therapeutic option for treating patients with invasive
aspergillosis.
- Nathan Wiederhold, Pharm.D. from the University of Texas Health
Science Center San Antonio, presented the poster, “The Novel
Antifungal VL-2397 Demonstrates Efficacy in an In
Vivo Model of Invasive Candidiasis Caused by Wild-Type and
Multi-Drug Resistant Candida glabrata.” In this NIH-sponsored in
vivo study, VL-2397 demonstrated efficacy in an experimental model
of invasive candidiasis caused by C. glabrata. Its efficacy,
as measured by reductions in kidney fungal burden, was evident
against infections caused by both wild-type and multi-drug
resistant isolates. The results demonstrate the therapeutic
potential of VL-2397 against invasive C. glabrata infections.
The FDA has granted Vical Qualified Infectious
Disease Product (QIDP), Orphan Drug and Fast Track designations for
VL-2397 in the treatment of invasive aspergillosis. Under the QIDP
designation Vical has been able to interact regularly with the FDA
on the Phase 2 trial design and a potential expedited development
pathway for VL‑2397.
About VicalVical develops
biopharmaceutical products for the prevention and treatment of
chronic or life-threatening infectious diseases, based on its
patented DNA delivery technologies and other therapeutic
approaches. Additional information on Vical is available at
www.vical.com.
Forward-Looking StatementsThis
press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ
materially from those projected. Forward-looking statements include
anticipated developments in clinical programs, including the plans,
timing of initiation, and enrollment for clinical trials. Risks and
uncertainties include whether Vical or others will continue
development of VL-2397; whether Vical will be able to
obtain regulatory allowances or guidance necessary to proceed with
proposed clinical trials or implement anticipated clinical trial
designs; whether on-going or planned clinical trials will be
initiated or completed on the timelines Vical currently expects,
whether any product candidates will be shown to be safe and
efficacious in clinical trials; whether Vical will have access to
sufficient capital to fund its planned development activities;
whether Vical will seek or gain approval to market any product
candidates; and additional risks set forth in the Company's filings
with the Securities and Exchange Commission. These forward-looking
statements represent the Company's judgment as of the date of this
release. The Company disclaims, however, any intent or obligation
to update these forward-looking statements.
Contact:
Andrew Hopkins
(858) 646-1127
Website: www.vical.com
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