Liponex Inc. reported that more than 20 per cent of patients saw a rise in "good cholesterol" of more than 10 per cent after using the lower dose levels of its lead drug candidate.
The Ottawa-based biopharmaceutical company is currently conducting Phase I/II clinical trials for CRD5, a drug which is being developed to treat heart disease and raise high-density lipoprotein (HDL) or "good cholesterol" levels in the body.
The overall mean HDL increase was five per cent at both the one-gram and three-gram dosing levels, but Liponex noted that patient-to-patient variation was high.
"While some patients had a negative response, over 20 per cent of patients achieved more than a 10 per cent rise in HDL at the lower dose levels," the company said in a release.
The company pointed specifically to the positive effects of proton pump inhibitors (PPI) such as ranitidine and lansoprazole, which reduce gastric acid production and reduce the acidity of the stomach, on CRD5 efficacy. Patients that regularly took PPI drugs such as Zantac or Prevacid during the trial showed a 16-per-cent HDL increase at the one-gram dose and a 14-per-cent HDL increase at the three-gram dose.
Liponex said CRD5 was shown to be safe in patients with dyslipidemia, a lipoprotein metabolism disorder which may cause lipoprotein overproduction or deficiency, with the exception of those patients who had had gastrointestinal problems after taking its higher-dose five-gram drugs. The company had in January halted tests on its five-gram dosage after reporting the adverse effects in test subjects.
"We are very encouraged by these results. We are seeing the best effect in patients that can most benefit from CRD5, at dose levels that are commercially viable," Liponex chief executive Bill Dickie. "These results, particularly the impact of proton pump inhibitors on CRD5 efficacy, support our ongoing preclinical studies and guide our strategy to optimize the formulation and dosing regimen for CRD5 clinical development."
The company said it would continue to work on CRD5's sensitivity to pH levels in the body, and announced an additional clinical trial with results expected in the first quarter of 2008.
At closing, Liponex's share price was 38 cents.
Last month, Liponex's shares plunged after the company announced disappointing results in its trials of CRD5. The company saw a phenomenal 250-per-cent jump in its share price in the previous four months after Pfizer pulled its "good cholesterol" torcetrapib drug from the market, putting Liponex's CRD5 in the lead as the first good cholesterol-increasing drug on the market.
To read more about Liponex and its market opportunity, click Pfizer's Fizzle to read a story from December by OBJ reporter Krystle Chow.