Loading...
Loading...
Ampio Pharmaceuticals, Inc.
today announced an update on the phase III, multicenter,
double-blind STEP study of Ampion™ for osteoarthritis of the knee.
Ampio Pharmaceuticals Logo.
The STEP study enrolled 538 patients, 269 patients received Ampion™ and 269
patients received saline vehicle control. There were two primary endpoints: 1.
Efficacy in reducing pain, as measured by the WOMAC A pain subscore and 2.
Safety of Ampion™ as measured by adverse events (AEs). The WOMAC C Function
subscore was examined as a secondary endpoint. Changes in pain and function
from baseline between Ampion™ and saline treatment groups were analyzed using
a mixed model, adjusted for baseline score. Safety was examined in the safety
dataset while efficacy was analyzed in the per-protocol (PP) population, in
which patients met all entry criteria and had no major protocol deviations.
There were 475 patients included in the PP population (242 received Ampion™
and 233 received saline vehicle control).
Review of the data from the STEP study confirmed that 382 (72%) patients
received study medication that had fallen below the product specification
temperature range. The average length of exposure below this temperature range
was 16.1 hours (maximum: 36.3 hours). This technical difficulty was out of
the control of Ampio (Sponsor) and affected our ability to perform the
statistical analysis according to plan. We believe the temperature deviations
that were present in the 72% of patients likely affected the level of active
ingredients in the injected dose of Ampion™. Despite this difficulty efficacy
was demonstrated in patients with the most severe form of OA (KL IV, where the
number of patients was sufficient for statistical analysis) for which the only
current alternative therapy is knee joint replacement.
The company plans to present safety data From the Australian phase I and Phase
II studies as well as the SPRING, STEP and Multiple Injections studies for the
BLA. Efficacy data for the BLA will be drawn from the SPRING and Multiple
Injections Study. The company plans to submit the BLA before the end of Q1
2015.
Efficacy:
Although the majority of patients received study drug that had fallen below
recommended temperature ranges, some important information on the efficacy of
Ampion™ could be gleaned from this trial.
o The treatment effect differed based on the temperature excursion from the
recommended range (interaction p < 0.001). Patients receiving study drug
with temperature excursions had varying treatment effects depending on the
lowest temperature that was reached during transport of the study drug.
o There was a significant interaction observed between OA severity, as
measured by Kellgren-Lawrence grade, and treatment effect (interaction p <
0.001). The strongest effects of Ampion™ were observed in the patients
with severe OA of the knee (Kellgren-Lawrence grade IV, KL IV), for which
there are no current drug therapies available:
o Over one-third of patients enrolled were Kellgren-Lawrence grade IV
(n=185).
o The change in WOMAC A Pain from baseline to week 20 for all 185 KL IV
patients, inclusive of temperature excursions, was trending towards
significantly greater reductions in pain following treatment with
Ampion™ (-0.86), than that of saline vehicle control (0.66), p =
0.08. The change in WOMAC C Function from baseline to week 20 was
also trending towards significantly greater improvements in function
following treatment with Ampion™ (-0.84), than that of saline
(-0.64), p = 0.07.
o In KL IV patients with temperature excursions (134 patients),
significantly greater reductions in pain were reported following
treatment with Ampion™ (-0.85) compared to saline (-0.58), p = 0.04.
Likewise, there was a significantly greater improvement in function
following treatment with Ampion™ (-0.87) compared to saline (-0.59),
p = 0.03.
Safety:
o Overall, there were 249 adverse events (AEs) reported: 118 (44%) in
Ampion™ and 131 (49%) in Saline control.
o The most common AE was arthralgia (joint pain), reported in 13% and
11% in the patients treated with Ampion™ and saline, respectively.
o The majority of AEs were of minor severity (118 events, 47%),
followed by moderate (115 events, 46%) and severe (16 events, 6%).
Minor, moderate, and severe adverse events were similar in patients
treated with Ampion™ (24%, 22%, 3%, respectively) compared to saline
(20%, 21%, 3%).
o No serious adverse events (SAE) were reported related to study drug.
Loading...
Loading...
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in