Renewed Interest in Multiple Sclerosis Drug

MS: Did a pharma giant back away from a drug candidate too soon?

A potential new multiple sclerosis (MS) drug has shown positive phase 2a results, just four months after its German pharma sponsor Merck KCaA backed away from a co-development agreement.

Apitope, a British/Belgian biotech company, this week said that its lead product candidate, ATX-MS-1467, reduced total and new T1 Gadolinium enhancing (Gd+) lesions in MS patients, and reduced the volume of those lesions, as measured using MRI.

The results are encouraging news for the company, which last October re-acquired the full rights to the drug following a seven-year agreement with Merck KGaA, in which the German pharma giant took over development of the drug and planned to oversee its commercialization.

Apitope CEO Keith F. Martin, PhD, MIoD, MRPharmS, expressed confidence about the future prospects of his company’s drug candidate.

“We are delighted with these positive results that confirm both clinical findings in our phase 1b trial as well as preclinical results showing significant decreases in MRI detected lesions and disability in a standard multiple sclerosis model,” said Martin, in a press release.

The treatment consists of four synthetic peptides derived from myelin basic protein. The therapy is designed to alter the body’s autoimmune response in order to limit myelin attacks. The drug is meant to target around 70% of MS patients who fit a specific genetic profile.

The phase 2a study looked at the drug’s impact on 19 patients with relapsing MS. ATX-MS-1467 was administered intradermally every two weeks for 20 weeks.

In addition to reductions in Gd+ lesions, patients also had improved Multiple Sclerosis Function Composite (MSFC) scores, no serious treatment-related adverse events were reported, and the drug’s adverse event profile was described as mild.

The drug was previously tested in a pair of phase1 trials, wherein the ATX-MS-1467 was administered to patients with secondary progressive MS and relapsing MS. Those results, plus the new phase 2a results, ought to catch the attention of the industry, said Jeremy Chataway MA, PhD, FRCP, a consulting neurologist, who works at the National Hospital for Neurology and Neurosurgery, in London.

“While these patients were only treated for 20 weeks, results in a phase 2b study with a longer treatment period will be interesting,” Chataway said, in an Apitope press release.

When Merck first partnered with Apitope in 2009, the company made an upfront payment and agreed to fund development costs and make milestone payments. That amount ended up totaling about $169 million.

However, Merck decided last fall to give up on the Apitope partnership, even before the phase 2b results were in. The company did not release a statement at the time explaining its decision to drop the arrangement.

For its part, Apitope said Merck’s decision freed up the company to have more flexibility and control over ATX-MS-1478’s development. The company said it would be pursuing future partnerships to help fund further development of the therapy. The current target date for commercial launch of the drug is 2026.

In addition to ATX-MS-1478, Apitope’s pipeline also includes two other MS drugs, as well as potential therapies for Grave’s Disease, Factor VIII intolerance, and uveitis.

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