Biodel's Concentrated Insulin BIOD-531 Demonstrates Superior Glucose Control Following Standardized Meals Compared to Marketed

Biodel's Concentrated Insulin BIOD-531 Demonstrates Superior Glucose Control 
Following Standardized Meals Compared to Marketed Insulins in
a Phase 2 Clinical Trial in Patients With Type 2 Diabetes 
Phase 2a Clinical Trial Data Demonstrate That a Single Dose of
BIOD-531 Provides Superior Glucose Control After Two Consecutive
Standardized Meals Compared to Humalog (R) Mix 75/25 and Humulin(R) R
U-500; Conference Call and Webcast Will Be Held in Conjunction With
Third Quarter Fiscal Year 2014 Financial Results Update on Monday,
August 11, 2014 at 5:00 pm EDT 
DANBURY, CT  -- (Marketwired) -- 08/11/14 --  Biodel Inc. (NASDAQ:
BIOD) announced positive preliminary results from Study 3-152, a
Phase 2a clinical trial comparing Biodel's proprietary, concentrated
insulin formulation BIOD-531 to Humalog® Mix 75/25 and Humulin® R
U-500 in patients with type 2 diabetes with moderate insulin
resistance who use between 50 and 200 units of insulin per day.  
Data Highlights 


 
--  BIOD-531 was associated with superior glucose control compared to
    Humalog® Mix 75/25 throughout the day of observation.
--  BIOD-531 was also associated with superior glucose control compared to
    Humulin® R U-500.
--  BIOD-531 dosed 20 minutes after the start of the standardized breakfast
    also resulted in superior glucose control compared to either Humalog®
    Mix 75/25 or Humulin® R U-500 dosed prior to the meal. 
--  Mean visual analog scores and absolute severity scores were low for all
    participants, suggesting excellent injection site tolerability.

 
Many type 2 diabetes patients in clinical practice are treated with
pre-mixed insulins, such as Humalog® Mix 75/25, in order to receive
both basal and prandial insulin in a single injection. Pre-mixed
insulin is commonly dosed before breakfast and before dinner and is
usually used in patients who are not candidates for an intensive
basal-bolus insulin regimen that would require four or more
injections per day. Humulin® R U-500 is the only concentrated insulin
available in the U.S. and is usually used to treat type 2 diabetes
patients with severe insulin resistance who require very high doses
of insulin -- typically greater than 200 units per day.   
BIOD-531 is an ultra-rapid-acting formulation of recombinant human
in
sulin (RHI) at a concentration of 400 units/ml (U-400) combined
with EDTA, citrate and magnesium sulfate. In the Phase 1 Study 3-150,
the results of which were released in February 2014, BIOD-531
administered to non-diabetic, obese volunteers demonstrated
ultra-rapid absorption and onset of action in comparison with
Humalog® Mix 75/25 and Humulin® R U-500, and had an extended duration
of action that is expected to be suitable for basal insulin needs.  
The recently completed Study 3-152 was designed to test the
hypothesis that a single dose of BIOD-531 would confer better
postprandial glucose control for two consecutive meals compared to
Humalog® Mix 75/25 when administered to type 2 diabetes patients with
moderate insulin resistance.   
In Study 3-152, glucose profiles were assessed after single
subcutaneous injection of 0.6 U/kg doses of the study drugs
administered with a standardized breakfast on separate days in a
randomized four arm cross-over sequence in which subjects received
pre-meal BIOD-531, pre-meal Humalog® Mix 75/25, pre-meal Humulin® R
U-500 and post meal BIOD-531. In order to assess the duration of
glucose lowering, subjects received a standardized lunch at 330
minutes (5.5 hours) after breakfast dosing with no insulin
administered at that time. Glucose levels were measured every five
minutes during the 720 minutes (12 hours) after test insulin dosing
at breakfast.  
The results of the current study demonstrate that the
ultra-rapid-acting profile with an extended duration of action of
BIOD-531 seen in Study 3-150 may translate into clinically meaningful
benefits of superior mealtime and basal coverage for type 2 diabetes
patients with moderate insulin resistance.  
Pre-Meal Administration of BIOD-531 vs. Pre-Meal Administration of
Humalog® Mix 75/25 
BIOD-531 was associated with superior glucose control compared to
Humalog® Mix 75/25 throughout the day of observation. A single dose
of BIOD-531 administered immediately before breakfast (pre-meal)
achieved significantly lower mean glucose concentrations than did
Humalog® Mix 75/25 administered immediately before breakfast. The
mean glucose concentration after breakfast was 167.8 +/- 10.4 mg/dl
with BIOD-531 treatment compared to 205.1 +/- 8.3 mg/dl with Humalog®
Mix 75/25 treatment (p < 0.001). Mean glucose concentrations were
also significantly improved after lunch with pre-meal BIOD-531. Over
the course of the entire day of observation, pre-meal BIOD-531 was
associated with an average glucose concentration of 177.8 +/- 11.9
mg/dl compared to 225.1+/- 10.7 mg/dl with Humalog® Mix 75/25
treatment (p < 0.001). The percentage of glucose readings within
the target range of 70-180 mg/dl was increased more than two-fold
following BIOD-531 treatment (46.3 +/- 8.4%) compared to Humalog® Mix
75/25 treatment (20.6 +/- 5.9 %; p=0.002). Likewise, the
post-breakfast area under the curve for the glucose excursion and the
mean maximal glucose concentrations after breakfast and after lunch
were significantly improved with pre-meal BIOD-531 treatment compared
to Humalog® Mix 75/25 treatment. 
Pre-Meal Administration of BIOD-531 vs. Pre-Meal Administration of
Humulin® R U-500
BIOD-531 was also associated with superior glucose control compared
to Humulin® R U-500. Mean glucose concentrations after the
standardized breakfast were 167.8 +/- 10.4 mg/dl with BIOD-531
treatment compared to 193.1 +/- 8.3 mg/dl with Humulin® R U-500
treatment (p=0.006). Over the entire day of observation, mean glucose
concentrations were 177.8 +/- 11.9 mg/dl with BIOD-531 treatment
compared to 197.2 +/- 8.8 mg/dl with Humulin® R U-500 treatment
(p=0.042). Over the course of the entire day of observation, glucose
concentrations were in the target range of 70-180 mg/dl 46.3 +/- 8.4%
of the time with BIOD-531 treatment compared to 29.1 +/- 6.1% of the
time with Humulin® R U-500 treatment (p=0.032).  
Post-Meal Administration of BIOD-531 vs. Pre-Meal Administration of
Humalog® Mix 75/25 and Pre-Meal Administration of Humulin® R U-500
BIOD-531 dosed 20 minutes after the start of the standardized
breakfast also resulted in a superior glucose control compared to
either Humalog® Mix 75/25 or Humulin® R U-500 dosed prior to the
meal. Mean glucose concentrations over the course of the day were
178.3 +/- 11.2 mg/dl for post-meal BIOD-531 treatment compared to
225.1 +/- 10.7 for pre-meal Humalog® Mix 75/25 treatment (p <
0.001). The percentage of readings within the 70-180 mg/dl target
range was 46.2 +/- 7.6% for post-meal BIOD-531 treatment compared to
20.6 +/- 5.9% for pre-meal Humalog® Mix 75/25 treatment (p=0.003) and
29.1 +/- 6.1% for pre-meal Humulin® R U-500 treatment (p=0.040).  
Safety and Tolerability
Mean visual analog scores and absolute severity scores were low for
all participants, suggesting excellent injection site tolerability.
There were no statistically significant differences in 100 mm visual
analog scores among the treatment groups.   
Dr. Alan Krasner, chief medical officer of Biodel, stated: "Many
patients with type 2 diabetes who use pre-mixed insulins such as
Humalog® Mix 75/25 may not achieve adequate prandial control due to
the slow absorption of currently available, pre-mixed insulin
formulations. These dat
a released today validate the benefits of the
ultra-rapid-acting onset of action of BIOD-531 seen in our previous
Phase 1 study and clearly demonstrate the clinical superiority of
this profile on post-prandial glucose control compared to Humalog®
Mix 75/25 and Humulin® R U-500. The longer-term coverage provided by
BIOD-531 was superior to the comparators as seen in lower glucose
levels after the standardized lunch and the benefits are maintained
even when dosed after the meal. This unique pharmacokinetic and
pharmacodynamic profile, coupled with its high concentration and low
injection volume has the potential to confer clinically significant
benefits to a sub-optimally served population of patients with type 2
diabetes."  
Dr. Errol De Souza, president and chief executive officer of Biodel,
stated: "BIOD-531 is a valuable asset within Biodel's expanding
portfolio. It appears from these data that BIOD-531 may have utility
both in the niche but rapidly growing segment of insulin resistant
patients largely treated by endocrinologists and currently served by
Humulin® R U-500, as well as in the much larger segment of patients
currently using pre-mixed insulins and often managed by primary care
physicians. We are working with the FDA to define the clinical
development program that will best characterize and assess this
unique formulation so that we can rapidly advance BIOD-531 into later
stage clinical trials. We look forward to updating you in the fourth
quarter of 2014 on the data from the ongoing Phase 2 Study 3-151 in
severely insulin resistant patients and the path forward for this
exciting product opportunity." 


 
                                                                            
----------------------------------------------------------------------------
 Blood Glucose Profiles of BIOD-531 Vs. Humalog®Mix 75/25 or Humulin®R U-500
                    Following Standardized Meal Challenges                  
----------------------------------------------------------------------------
                Efficacy                                                    
    Meal        Parameter              Treatment Group Comparison           
                            ------------------------------------------------
                                        Humalog®Mix  Humulin®R              
                               BIOD-       75/25       U-500       BIOD-    
                             531Before  Before Meal Before Meal   531After  
                              Meal (A)      (B)         (C)       Meal (D)  
                                                                            
                                                                            
----------------------------------------------------------------------------
                                                                            
----------------------------------------------------------------------------
            Change BGAUC0-                                                  
After        120min(mg.min/   7140 +/-   10302 +/-    8160 +/-    7319 +/-  
 Breakfast*  dl)                962         1051        533         889     
            ----------------------------------------------------------------
            Change BGAUC0-                                                  
             330min(mg.min/  23526 +/-   33751 +/-   30158 +/-   23833 +/-  
             dl)                3054        2396        2342        3846    
            ----------------------------------------------------------------
            Avg BG0-         167.8 +/-   205.1 +/-   193.1 +/-   173.4 +/-  
             330min(mg/dl)      10.4        8.3         8.3         11.6    
            ----------------------------------------------------------------
            BGMaximum0-      192.9 +/-   233.7 +/-   212.8 +/-   195.3 +/-  
             120min(mg/dl)      12.3        12.5        7.0         10.7    
            ----------------------------------------------------------------
            Percent                                                         
             Values5-330min                                                 
             Within 70- <                                                   
             80 mg/dl Range   52.7 +/-    28.0 +/-    33.5 +/-    48.6 +/-  
             (%)                10.3        9.1         9.5         10.3    
----------------------------------------------------------------------------
                                                                            
----------------------------------------------------------------------------
After       Avg BG5-         186.3 +/-   241.9 +/-   200.7 +/-   176.4 +/-  
 Lunch**     390min(mg/dl)      15.0        15.3        11.6        14.9    
            ----------------------------------------------------------------
            BGMaximum0-      237.6 +/-   297.3 +/-   256.3 +/-   230.4 +/-  
             120min(mg/dl)      15.5        16.1        13.4        14.4    
            ----------------------------------------------------------------
            Percent                                                         
             Values0-390min                                                 
             Within 70- <                                                   
             80 mg/dl Range   41.1 +/-    13.6 +/-    25.7 +/-    43.8 +/-  
             (%)                9.1         6.4         6.9         9.8     
----------------------------------------------------------------------------
                                                                            
----------------------------------------------------------------------------
Overall     Avg Glucose0-                                                   
 Test        720min(mg/dl)   177.8 +/-   225.1 +/-   197.2 +/-   178.3 +/-  
 Period                         11.9        10.7        8.8         11.2    
            ----------------------------------------------------------------
            Percent                                                         
             Values5-720min                                                 
             Within 70- <                                                   
             80 mg/dl Range   46.3 +/-    20.6 +/-    29.1 +/-    46.2 +/-  
             (%)                8.4         5.9         6.1         7.6     
----------------------------------------------------------------------------
                                                                            
----------------------------------------------------------------------------
 
                                                                          
--------------------------------------------------------------------------
 Blood Glucose Profiles of BIOD-531 Vs. Humalog®Mix 75/25 or Humulin®R U- 
                 500 Following Standardized Meal Challenges               
--------------------------------------------------------------------------
                Efficacy                                                  
    Meal        Parameter             Treatment Group Comparison          
                           -----------------------------------------------
                                               P Value                    
                           -----------------------------------------------
                           (A) vs
. (B) (A) vs. (C) (B) vs. (D) (C) vs. (D)
--------------------------------------------------------------------------
                                                                          
--------------------------------------------------------------------------
            Change BGAUC0-                                                
After        120min(mg.min/                                               
 Breakfast*  dl)              0.001       0.228       0.002       0.319   
            --------------------------------------------------------------
            Change BGAUC0-                                                
             330min(mg.min/                                               
             dl)              0.003       0.036       0.004       0.051   
            --------------------------------------------------------------
            Avg BG0-                                                      
             330min(mg/dl)   < 0.001      0.006       0.001       0.031   
            --------------------------------------------------------------
            BGMaximum0-                                                   
             120min(mg/dl)   < 0.001      0.050      < 0.001      0.082   
            --------------------------------------------------------------
            Percent                                                       
             Values5-330min                                               
             Within 70- <                                                 
             80 mg/dl Range                                               
             (%)              0.026       0.074       0.067       0.172   
--------------------------------------------------------------------------
                                                                          
--------------------------------------------------------------------------
After       Avg BG5-                                                      
 Lunch**     390min(mg/dl)   < 0.001      0.205      < 0.001      0.060   
            --------------------------------------------------------------
            BGMaximum0-                                                   
             120min(mg/dl)   < 0.001      0.212      < 0.001      0.101   
            --------------------------------------------------------------
            Percent                                                       
             Values0-390min                                               
             Within 70- <                                                 
             80 mg/dl Range                                               
             (%)              0.002       0.072       0.001       0.042   
--------------------------------------------------------------------------
                                                                          
--------------------------------------------------------------------------
Overall     Avg Glucose0-                                                 
 Test        720min(mg/dl)                                                
 Period                      < 0.001      0.042      < 0.001      0.058   
            --------------------------------------------------------------
            Percent                                                       
             Values5-720min                                               
             Within 70- <                                                 
             80 mg/dl Range                                               
             (%)              0.002       0.032       0.003       0.040   
--------------------------------------------------------------------------
                                                                          
--------------------------------------------------------------------------
 

 
Data presented are the Mean +/- SEM from twelve subjects randomized. One of 
these subjects discontinued after treatment with Humalog® Mix 75/25 and     
Humulin® R U-500 only. Blood glucose was measured every 5 minutes.          
BG: Blood glucose; Change BG: Change in blood glucose from baseline; AUC:   
Area under the glucose response curve                                       
*Test insulin was administered only for the breakfast meal                  
**No insulin treatment was administered at lunch (330 min after injection)  
----------------------------------------------------------------------------

 
Study Design
Study 3-152 was a single-blinded, four-arm cross-over study. Twelve
subjects were randomized and 11 patients completed the study. The
patients evaluated in this study were a typical population with type
2 diabetes who used between 50-200 units of insulin per day with mean
age of 55 years old, mean baseline HbA1c of 9%, mean weight of 99 kg,
and mean BMI of 33.5 kg/m2. Subjects were washed out of background
diabetes medications (including insulins) and admitted to the
research unit the evening before study drug dosing. Overnight, blood
glucose concentration was stabilized at the target range of 100 +/-
20 mg/dl using intravenous insulin. The intravenous insulin was
discontinued no later than 15 minutes before a standardized breakfast
in the morning. Each subject came in for the following four
treatments administered subcutaneously on separate days assigned in a
random order: (a) BIOD-531 immediately before the meal (pre-meal);
(b) Humalog® Mix 75/25 pre-meal; (c) Humulin® R U-500 pre-meal; and
(d) BIOD-531 twenty minutes after the start of the meal (post-meal).
The dose for each session was 0.6 U/kg. After the breakfast, glucose
concentrations were measured every 5 minutes throughout the day for a
total of 720 minutes (12 hours) after insulin dosing. In order to
assess the duration of glucose control of the test insulins, the
subject received a standardized lunch 330 minutes (5.5 hours) after
breakfast dosing but did not receive a lunch-time dose of insulin.
Injection site toleration was assessed with a 100 mm visual analog
scale and severity scores.  
About BIOD-531
Biodel's concentrated insulin BIOD-531 contains 400 units per
milliliter (U-400) of recombinant human insulin formulated with EDTA,
citrate and magnesium sulfate. Based on its unique combination of
ultra-rapid absorption with a basal duration profile, BIOD-531 may
provide superior meal-time glucose control for patients using
Humulin® R U-500 and pre-mixed insulins such as Humalog® Mix 75/25.
Furthermore, for patients using pre-mixed prandial/basal insulins,
BIOD-531 could enable patients to minimize injection volume while
benefitting from the ultra-rapid onset of action.  
The current unmet medical need for a concentrated ultra-rapid-acting
insulin formulation exists among a subset of type 2 diabetes patients
who demonstrate severe insulin resistance and require greater than
200 units of insulin daily to meet their insulin needs. Currently Eli
Lilly's Humulin® R U-500 is the only concentrated insulin product on
the U.S. market. Humulin® R U-500 concentrated insulin has a
suboptimal pharmacokinetic and pharmacodynamic profile for prandial
coverage, with a more delayed onset than U-100 regular human insulin
or rapid-acting insulin analog formulations.  
Eli Lilly and Novo Nordisk market preparations of human insulin or
rapid-acting analog prandial insulins pre-mixed with
intermediate-acting basal neutral protamine insulins in a variety of
ratios such as 70/30, 75/25 and 50/50. Pre-mixes provide basal and
bolus therapy with fewer injections per day. Pre-mixed prandial/basal
insulins have a suboptimal pharmacokinetic and pharmacodynamic
profile with a more delayed onset than prandial U-100 regular human
insulin or rapid-acting insulin analog formulations. Pre-mixes
represent approximately thirty percent of the more than $8 billion
global rapid-acting prandial insulin market.  
Conference Call and Webcast Information 
Biodel's senior management will host a conference call in conjunction
with Third Quarter Fiscal Year 2014 Financial Results Update on
Monday, August 11, 2014 at 5:00 p.m. Eastern Daylight Time to discuss
these results and provide a company update. Live audio of the
conference call will be available to investors, members of the news
media and the general public by dialing +1 (877) 407-7181 (Toll-Free
US & Canada) or +1 (201) 689-8047 (International). To access the call
by live audio webcast, please log on to the investor section of the
company's website at www.biodel.com. An archived version of the audio
webcast will be available on Biodel's website or by dialing +1 (877)
660-6853 (Toll Free US & Canada) or +1 (201) 612-7415 (International)
and entering conference ID number 13588552.  
About Biodel Inc.  
Biodel Inc. is a specialty biopharmaceutical company focused on the
development and commercialization of innovative treatments for
diabetes that may be safer, more effective and more convenient 
for
patients. Biodel's product candidates are developed by applying
proprietary technologies to existing drugs in order to improve their
therapeutic profiles. More information about Biodel is available at
www.biodel.com.   
Safe-Harbor Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include statements about future activities
related to the clinical development plans for the company's drug
candidates, including the potential timing, design and outcomes of
clinical trials; and the company's ability to develop and
commercialize product candidates. Forward-looking statements
represent our management's judgment regarding future events. All
statements, other than statements of historical facts, including
statements regarding our strategy, future operations, future clinical
trial results, future financial position, future revenues, projected
costs, prospects, plans and objectives of management are
forward-looking statements. The words "anticipates," "believes,"
"could," "estimates," "expects," "intends," "may," "plans,"
"potential," "predicts," "projects," "should," "will," "would" and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. The company's forward-looking statements are
subject to a number of known and unknown risks and uncertainties that
could cause actual results, performance or achievements to differ
materially from those described or implied in the forward-looking
statements, including, but not limited to, the success of our product
candidates, particularly our proprietary formulations of injectable
insulin that are designed to be absorbed more rapidly than the
"rapid-acting" mealtime insulin analogs presently used to treat
patients with type 1 and type 2 diabetes and our glucagon
presentation that is intended to treat patients experiencing severe
hypoglycemia; our ability to conduct pivotal clinical trials, other
tests or analyses required by the U.S. Food and Drug Administration,
or FDA, to secure approval to commercialize a proprietary formulation
of injectable insulin or a stable glucagon presentation; the success
of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a stable
glucagon presentation; our ability to secure approval from the FDA
for our product candidates under Section 505(b)(2) of the Federal
Food, Drug, and Cosmetic Act; the progress, timing or success of our
research, development and clinical programs, including any resulting
data analyses; our ability to develop and commercialize a proprietary
formulation of injectable insulin that may be associated with less
injection site discomfort than Linjetaâ„¢ (formerly referred to as
VIAject®), which is the subject of a complete response letter we
received from the FDA; our ability to enter into collaboration
arrangements for the commercialization of our product candidates and
the success or failure of any such collaborations into which we
enter, or our ability to commercialize our product candidates
ourselves; our ability to protect our intellectual property and
operate our business without infringing upon the intellectual
property rights of others; the degree of clinical utility of our
product candidates; the ability of our major suppliers to produce our
products in our final dosage form; our commercialization, marketing
and manufacturing capabilities and strategies; our ability to
accurately estimate anticipated operating losses, future revenues,
capital requirements and our needs for additional financing; and
other factors identified in our most recent report on Form 10-Q for
the quarter ended December 31, 2013. The company disclaims any
obligation to update any forward-looking statements as a result of
events occurring after the date of this press release. 
BIOD-G  
CONTACT: 
John Graziano
+1-646-378-2942
 
 
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