— Data Showed ALKS 3831 Significantly Attenuated Antipsychotic-Related Weight Gain —
— Alkermes Plans to Initiate Phase 2 Study in Mid Calendar 2013 —
The multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight in 106 healthy volunteers following three weeks of once-daily, oral administration of ALKS 3831, compared to olanzapine alone or placebo. Data from the study showed that patients administered ALKS 3831 demonstrated significantly less weight gain compared to patients taking olanzapine. Weight gain is a common and clinically relevant side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.1
Based on the positive results of the phase 1 study,
“Based on these encouraging results, we are very excited to advance ALKS
3831 as one of our proprietary clinical candidates as we continue to
expand Alkermes’ strength as a developer of novel CNS medications for
unmet patient needs,” said Richard Pops, Chief Executive Officer of
“Antipsychotic-induced weight gain is a common side effect and area of
medical concern in the treatment of patients with schizophrenia. We
believe a combination therapy that could reduce the metabolic side
effects of olanzapine, without inhibiting olanzapine’s antipsychotic
activity, would provide significant value to physicians and patients,”
stated
The phase 1, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight following three weeks of oral administration of ALKS 3831 in a study that included 106 healthy, normal-weight male volunteers. ALKS 3831 was generally well tolerated in the study, and the safety and tolerability results for ALKS 3831 were similar to those observed with olanzapine alone. Healthy volunteers who received ALKS 3831 gained an average of 2.5 kg (5.5 lbs), while subjects who received olanzapine alone gained an average of 3.4 kg (7.5 lbs). The difference between the ALKS 3831 treatment group and the control group receiving olanzapine alone was statistically significant over the three-week study period (p=0.014), with a trend indicating the potential for even greater differentiation over longer study periods.
About ALKS 3831
ALKS 3831, a proprietary drug compound for the treatment of schizophrenia, is the combination of ALKS 33, a potent opioid modulator, and the established antipsychotic agent, olanzapine. Weight gain is a common and clinically relevant side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.1 The weight gain side effect from atypical antipsychotics may be associated with the onset or exacerbation of diabetes and dyslipidemia, which are known risk factors for cardiovascular disease and mortality.2
In preclinical models, an ALKS 3831 regimen was shown to mitigate olanzapine-induced weight gain without affecting olanzapine’s ability to demonstrate efficacy in a standard preclinical model used to assess antipsychotic activity. In another preclinical study, ALKS 3831 was shown to attenuate olanzapine-induced weight gain and abdominal adipose accretion.
About
Note Regarding Forward-Looking Statements
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning the planned future development of ALKS 3831, including the expected timing of the phase 2 study; and the therapeutic value of ALKS 3831 and ALKS 33. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees; the company’s business is subject to significant risk and uncertainties, and there can be no assurance that its actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: whether preclinical
and early clinical results for ALKS 3831 and ALKS 33 will be predictive
of future clinical study results; whether future clinical trials for
ALKS 3831 will be completed on time or at all; whether there will occur
potential changes in cost, scope and duration of the ALKS 3831 clinical
development program; whether ALKS 3831 or ALKS 33 could be shown
ineffective or unsafe during clinical studies, and the company may not
be permitted by regulatory authorities to undertake new or additional
clinical studies for ALKS 3831 or ALKS 33; and those risks described in
the company’s Annual Report on Form 10-K for the year ended
ZYPREXA® is a registered trademark of
1Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S,
Duggan L, Kissling W, Leucht S. Olanzapine versus other atypical
antipsychotics for schizophrenia. Cochrane Database of Systematic
Reviews. 2010, Issue 3. Art. No.: CD006654.
2
Source:
Alkermes Contacts:
For Investors:
Rebecca
Peterson, +1 781 609 6378
or
For Media:
Jennifer Snyder,
+1 781 609 6166