Acura Pharmaceuticals, Inc (NASDAQ:ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that topline results from cohort 2 of clinical study AP-LTX-400 (Study 400) confirmed that LTX-04P tablets, a hydromorphone hydrochloride immediate-release tablet using the Company’s new LIMITX oral abuse deterrent technology, successfully retarded the release of the active opioid ingredient when four, six and eight intact tablets were ingested. The Company previously announced similar abuse deterrent findings from cohort 1 of Study 400 for a 3 tablet dose of LTX-04P but that additional formulation development will be required for LTX-04P to deliver a sufficient amount of the active ingredient to patients when one or two tablets are administered. The Company expects to resume clinical testing of a new formulation of LTX-04 in the fourth quarter of 2016 following completion of ongoing reformulation work and a discussion with the U.S. Food and Drug Administration (FDA) regarding the results of Study 400.
The patented LIMITX technology works by neutralizing stomach acid as increasing numbers of tablets are swallowed and relying on stomach acid to play a role in the release of the active ingredient from micro-particles contained in the tablets.
Cohort 2 of Study 400 studied 4, 6 and 8 tablet dosage subgroups of LTX-04P against the marketed comparator product, DILAUDID. Cohort 1 studied 1, 2 and 3 tablet dosage subgroups. Study 400 measured the rate and extent of absorption of the active drug ingredient into the blood stream with the maximum drug concentration, or Cmax, typically associated with an increase in drug abuse. Subjects in Study 400 had an average 22% reduction in relative Cmax when 3 or more tablets were ingested as shown in the table below.
|Study 400 – Mean Ratio of Cmax (ng/mL) by Dosing Group|
Compared to the 1 Tablet Group for the Same Formulation
| || ||Dosing in mg|| ||DILAUDID|| ||LTX-04P|| ||Change|
|2 Tablet Group|| ||2x|| ||1.9x|| ||2.2x|| ||15%|
|3 Tablet Group|| ||3x|| ||4.8x|| ||3.8x|| ||-22%|
|4 Tablet Group|| ||4x|| ||6.4x|| ||4.8x|| ||-25%|
|6 Tablet Group|| ||6x|| ||6.2x|| ||5.2x|| ||-15%|
|8 Tablet Group|| ||8x|| ||8.4x|| ||6.8x|| ||-18%|
| ||Average 3-8|| || || || || || || ||-22%|
All Subjects in cohort 2 had extent of drug absorption (measured by AUC) for LTX-04P comparable to DILAUDID when the same number of tablets were ingested. Likewise, the time to maximum plasma concentration, or Tmax, was comparable at all doses. All doses in Study 400 were generally well tolerated with no serious adverse event reported.
Dr. Al Brzeczko, Acura’s Vice President of Technical Affairs commented, “We are excited the dosing levels studied in cohort 2 of Study 400 confirmed the LIMITX technology concept of reducing Cmax as higher, more abused doses are ingested. Study 400 provided us with a wealth of data that we will mine to adjust our formulation to achieve better performance for the one and two tablet doses. We will also look to see if we can improve upon the abuse deterrent performance as well.”
“To see this level of abuse deterrence with our first test formulation is wonderful for this new technology,” noted Bob Jones, President and CEO of Acura. “We look forward to completing our analysis of Study 400, finishing our reformulation and getting back in the clinic as soon as possible.”
The Company continues to advance its reformulation work on the LIMITX technology micro-particles to improve the drug delivery with one and two tablets and hopes to have a dialogue with the FDA regarding these results and the next clinical phase under its Fast Track development designation for LTX-04. (Original Source)
Shares of Acura opened today at $2.46, up $0.01 or -0.30%. ACUR has a 1-year high of $6.75 and a 1-year low of $1.61. The stock’s 50-day moving average is $2.76 and its 200-day moving average is $2.38.
On the ratings front, Acura has been the subject of a number of recent research reports. In a report issued on May 3, FBR analyst Vernon Bernardino reiterated a Buy rating on ACUR, with a price target of $10, which implies an upside of 306.1% from current levels. Separately, on April 13, Roth Capital’s Michael Higgins reiterated a Buy rating on the stock and has a price target of $6.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Michael Higgins have a total average return of -11.9% and -11.3% respectively. Bernardino has a success rate of 35.3% and is ranked #3854 out of 3903 analysts, while Higgins has a success rate of 30.8% and is ranked #3719.
Acura Pharmaceuticals, Inc. operates as a pharmaceutical company, which engages in the research, development and commercialization of products intended to address medication abuse and misuse, utilizing its proprietary aversion and impede technologies. It operates its business through the research, development and manufacture of innovative abuse deterrent, orally administered pharmaceutical products.