Archive for the ‘cholesterol’ Category

May
18

New cloud hovers over class of ‘good cholesterol’ drugs

Posted under Blog, cholesterol, Companies, CTEP inhibitors, Diagnostics, Eli Lilly, Funding, HDL, heart disease, heart drug, John LaMattina, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Pipeline, Startups, Universities, Videos by Ryan McBride

Fresh doubts have cropped up for raising "good cholesterol" to combat heart attack risk, after a new study showed that patients genetically programmed to have higher levels of HDL cholesterol didn't appear to be more protected from heart disease than those with low levels. The news comes as Merck ($MRK) and Eli Lilly ($LLY) are spending millions of dollars to develop HDL-raising treatments, aiming to deliver on the blockbuster potential of the CETP drug class.

"I'd say the HDL hypothesis is on the ropes right now," said outside observer Dr. James A. de Lemos, a professor at the University of Texas Southwestern Medical Center, as quoted by The New York Times.

The HDL mechanism took a recent blow last week when Swiss drug giant Roche ($RHHBY) announced that it was nixing development of its contender designed to raise good cholesterol to thwart heart disease because of absent efficacy, following previous failures at Pfizer ($PFE) and Abbott ($ABT). Informed of the new genetic study revealed this week in The Lancet, Merck and Lilly representatives told the Times that the companies were both undeterred and continuing with their massive CETP programs. Yet the findings have dampened expectations for the drugs.

"This will have a sobering effect, it would have to," said John LaMattina, a senior partner at PureTech Ventures and former Pfizer R&D chief, as quoted by Bloomberg. "HDL has always been a controversial area. You have a question that you have to be willing to commit over a billion dollars in order to get the answer, and that is a very daunting commitment."

With billions of dollars in development costs and potential revenues on the line, expect scientists inside and outside of biopharma companies to take heed of the findings and dig deeper into the role of HDL in heart disease. As the Times notes, mouse studies showed that HDL carried cholesterol out of the arteries. But scientists will now look into whether HDL is an indicator or driver of reduced heart-attack risk.

- read the NYT's article
- and Bloomberg's report

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Apr
20

Alnylam scores efficacy data with PCSK9 drug

Posted under ALN-PCS, Alnylam Pharmaceuticals, Amgen, Blog, cholesterol, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, PCSK9 drugs, Pharmaceuticals, Pipeline, RNAi, Startups, Universities, Videos by rmcbride

Alnylam Pharmaceuticals' ($ALNY) stock rose this morning after the developer of gene-silencing drugs touted early-stage trial data on its RNA-interference drug that zeros in on one of the hottest targets in biotech. The data show that the small company has a horse in the race to advance PCSK9-targeting drugs as a brand new category of treatments for lowering LDL cholesterol.

The Cambridge, MA-based company's stock had jumped 5.6% as of 10:48 a.m. ET after Alnylam revealed the Phase I trial results early this morning.

The Phase I study met its primary goal of safety and tolerability of the treatment, called ALN-PCS, which was given to patients without cholesterol-lowering statins. And patients on the drug in the 32-person study had an average drop in LDL or "bad" cholesterol of 41% compared with baseline and placebo as well as a mean reduction in PCSK9 protein levels of 68% in the highest dose group. Alnylam says it plans to find a partner for the program before moving ahead with mid-stage trials with the drug.

Alnylam isn't as advanced in clinical development with its PCSK9-targeting drug as AMG 145, Amgen's ($AMGN) contender, or REGN727, which is Sanofi ($SNY) and Regeneron's ($REGN) drug that targets the protein. However, Alnylam's program could attract a partner interested in having a stake in PCSK9 drugs, which could offer an alternative cholesterol-lowering treatment for patients who don't respond to existing drugs such as statins. Analysts say the PCSK9-targeting class could be worth billions of dollars per year if they make it onto the market.

Alnylam also noted that ALN-PCS uses the company's next-generation lipid nanoparticle delivery technology, and the upbeat results from the company's small study could bode well for other drugs in its pipeline that use the delivery tech, such as ALN-TTR02. Delivery challenges have dogged the RNAi field, and Alnylam has been working on providing data that its next-gen drugs can overcome some of the hurdles that plagued programs of the past.

- here's Alnylam's release
- and an RTTNews report

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Mar
26

Sanofi, Regeneron report stellar LDL drug data as race heats up

Posted under Amgen, Blog, cholesterol, Companies, Diagnostics, Funding, Lipitor, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Startups, Universities, Videos by John Carroll

With an eye to keeping its lead on Amgen ($AMGN), Sanofi ($SNY) and Regeneron ($REGN) today noted that their rival PCSK9 inhibitor triggered a significant drop in LDL levels among patients with a high level of the "bad" kind of cholesterol. Responding to the promising Phase II data, Sanofi R&D chief Elias Zerhouni vowed to pivot into a late-stage program in the second quarter.

The key numbers for Sanofi were recorded in two groups among the 183 patients recruited for the study. In one group patients taking SAR236553/REGN727 in a subcutaneous injection twice a month registered a 72% mean drop in LDL compared to a 5% drop in the placebo arm. A separate cohort taking the twice-monthly treatment along with 80 mg of Lipitor saw a 73% reduction compared to an 18% drop for the Lipitor-only arm.

"I've not seen anything like this in all my days of research," says James McKenney, CEO of National Clinical Research and the lead investigator, who has been studying drugs for three decades. "This is so impressive."

The mid-stage data reflected an improvement over early-phase results, adds McKenney. In an interview with FierceBiotech he added that the longer you give the drug to a patient, the more efficacious it becomes. And one of the central objectives of this study was to zero in on the best dosage and frequency of treatment.

"No one else has finished the Phase II," he added. "We're the first ones out."

"There are a lot of implications for people who receive gold standard statins and either don't respond in a way that gives them a vigorous reduction or can't tolerate high doses, experiencing muscle pain and weakness," added McKenny. "That's the group that is an obvious low-hanging fruit that needs additional help. And this product based on what we found can give them a remarkable and dramatic additional lowering" of LDL. Later, he added, investigators will be able to assess the potential health benefits for the broader population.

Just how big that market might be triggered some chatter on Twitter over the weekend, with at least one analyst raising concerns that only a small subpopulation of patients could benefit from LDL drugs like the ones Amgen and Sanofi/Regeneron are investigating. But in a recent note, Jefferies analyst Biren Amin reportedly noted estimates that 77 million U.S. adults have high levels of LDL, with an estimated 3.4 million high-risk patients that could benefit most from a treatment like this.

According to their release, serious adverse events occurred in one patient receiving placebo and three patients in the active treatment arms, including a patient on active treatment who experienced a skin rash diagnosed as leukocytoclastic vasculitis.

"Based on this finding and the results of our Phase II trials, Sanofi and Regeneron plan to initiate the SAR236553/REGN727 Phase III program in the second quarter," says Zerhouni.

- here's the press release

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Mar
22

Developers spotlight huge potential of new class of cholesterol drugs

Posted under Amgen, Blog, cholesterol, cholesterol drug, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Regeneron Pharmaceuticals, Startups, Universities, Videos by John Carroll

Previewing the upcoming meeting of the American College of Cardiology meeting in Chicago, Reuters goes in-depth on a new class of potential blockbusters that will muscle its way into the R&D spotlight. The drugs inhibit the PCSK9 protein, offering a fresh approach to dramatically reducing levels of "bad" cholesterol.

At the top of the list of contenders is Regeneron Pharmaceuticals' ($REGN) REGN 727, which reduced LDL up to 65% in clinical trials. On Sunday, Amgen ($AMGN) will produce early-stage data on its anti-PCSK9 program, called AMG 145. And Reuters adds that Merck ($MRK) and others will muscle rivals in the field for attention as well.

Mani Mohindru, an analyst with Think Equity, tells Reuters that she "can't believe the cardiologists won't be in awe of the LDL reductions."

The developers certainly seem to be in awe of the potential of a new class of drugs that could be offered to millions of patients. "PCSK9 is one of the most exciting targets in cardiovascular drug development today," said Michael Severino, Amgen's chief medical officer.

- here's the story from Reuters

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Archive for the ‘cholesterol’ Category

New cloud hovers over class of ‘good cholesterol’ drugs

Alnylam scores efficacy data with PCSK9 drug

Sanofi, Regeneron report stellar LDL drug data as race heats up

Developers spotlight huge potential of new class of cholesterol drugs