Upcoming events – Bayer’s lung cancer effort and Apricus and Zealand try again

Welcome to your weekly digest of approaching regulatory and clinical readouts, including Bayer trying to beef up its presence in oncology as it advances a cyclin-dependent kinase inhibitor in small cell lung cancer.

Meanwhile, Apricus Biosciences and Zealand Pharma are looking to repeat pipeline success by generating positive phase II data with follow-up projects in the first quarter. Apricus hopes to show that fispemifene can modulate testosterone levels via the endocrine system, while Zealand wants prove itself worthy in hospital cardiovascular medicine.

Bayer’s lung cancer pill

While non-small cell lung cancer treatment is being revolutionised by checkpoint inhibitors, the small cell form lags behind, with chemotherapy agents still dominating the list of approved drugs. However, several companies are trying to change this, among them Bayer, whose cyclin-dependent kinase (CDK) inhibitor roniciclib should soon report phase II results.

The Concept-SCLC trial, which combined the project with chemotherapy in first-line SCLC, had a primary completion date of December 2015. Bayer hopes to show an improvement in progression-free survival versus placebo.

However, even if the results are positive roniciclib already looks like it might be behind the curve – Bristol-Myers Squibb’s PD-1-inhibiting juggernaut Opdivo is in phase III for SCLC and, if approved, looks certain to eclipse the drugs currently forecast to top the sales charts in 2020.

There are no forecasts available yet for roniciclib, and Bayer has been keeping quiet beyond reporting promising data from a phase Ib/II study at last year's European Cancer Congress.

CDK inhibitors got a boost last year with approval of Pfizer’s Ibrance in breast cancer (Palbo puts cyclin back on the agenda, February 04, 2015). Ibrance is also in phase II in lung cancer, but in NSCLC.

Moving away from the low-T gel

Apricus has the good fortune of having a product on the market in the form of Vitaros. It also has the misfortune that this erectile dysfunction product has underwhelmed.

Fispemifene, a follow-up, could help, however. This pill is in late phase II to treat sexual dysfunction in men with suppressed testosterone levels, or “low T”, a space that has been dominated by topical gels like AbbVie’s AndroGel and injections like Bayer’s Nebido. These products carry cardiovascular risk for patients and the potential for secondary exposure of family members ("Low-T" panel likely to lean towards risk aversion, September 4, 2014).

In the oral testosterone-modulating space fispemifeme trails Lipocine's LPCN 1021, a formulation of testosterone absorbed in the gastrointestinal tract due an FDA decision on June 28. Where Apricus’s pill differs is its mechanism of action – it blocks oestrogen production via the pituitary gland, which the company believes could normalise testosterone levels without prostate-related side effects.

The phase IIb study due to read out in the first quarter tested a 450mg once-daily dose of fispemifene against placebo over eight weeks, with the primary outcome being patients’ change in erectile function.

A successful readout could have Apricus in the partnering sights of sexual health specialists. Although the “low-T” space is largely genericised, a differentiated product with a better safety profile has a shot of reinvigorating the market.

First, do no harm

Zealand has benefited from its lixisenatide franchise, which Sanofi markets as Lyxumia, and could soon follow with the insulin combination LixiLan. The company's next developmental catalyst looks to be results from a phase II trial of danegaptide in preventing cardiac reperfusion injury.

After myocardial infarction the return of blood flow thanks to percutaneous coronary interventions and other medical techniques can damage ischaemic heart muscle cells because of contractile abnormalities.

Danegaptide is a gap junction modulating peptide. The Danish group’s hypothesis is that the lack of oxygen during myocardial infarctions reduces the permeability of the cellular gap junctions that allow electrical impulses to flow through heart muscle tissue and maintain normal contractile function. Reopening the gap junctions through use of danegaptide before or during cardiovascular interventions could prevent injury.

The phase II trial in 600 patients, randomised to one of two doses of danegaptide or placebo, will measure the myocardial salvage index following an ST-elevation myocardial infarction. This measure involves magnetic resonance imaging just after reperfusion and at three months to assess the total size of damaged tissue.

Analysts from Goldman Sachs reckon successful readout could trigger partnering talks with big pharma groups that have a focus on cardiology and hospital medicine, like Johnson & Johnson or The Medicines Company.

To contact the writer of this story email Madeleine Armstrong or Jonathan Gardner in London at news@epvantage.com or follow @medtech_ma or @ByJonGardner on Twitter

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