There was a much longer gap than I expected since my last post, so I’d like to start by looking at some updates in the clinical trial space for Sjogren’s Syndrome.
The first trial I would like to look at is the abatacept (Orencia) phase 3 trial, which I have blogged about several times, and the news isn’t good. First, the listing on clinicaltrials.gov was updated to move the estimated completion date back 4 years. Rumors are that the trial had disappointing data, and that Bristol-Myers Squibb is trying to figure out next steps. As this is the only systemic SS treatment that could have possibly been made available in the next several years, this is a setback if the rumors are proven true. Unfortunately, there is more bad news from the clinical trial pipeline:
- A phase 2 trial of the biologic Lulizumab from Bristol-Myers Squibb was terminated due to an inability to meet objectives.
- A phase 2 trial for prezalumab (MEDI5872) failed to reach its objectives and the drug has been dropped from development by AstraZeneca.
- The long and winding story of Baminercept, a protein that failed in RA trials in 2008, has concluded for SS with a failed phase 2 trial.
It’s not all bad news however, as there have been several success stories:
- Novartis had a very successful phase 2 trial of ianalumab (VAY736), a biologic drug, and is working on a phase 3 trial. This is a brand new biologic drug, and if the abatacept trial does indeed fail, ianalumab could well be the first approved systemic treatment for SS patients, though it is still years away.
- Another Novartis drug, CFZ533, has also completed a phase 2 trial, and another phase 2 trial is pending.
- RSLV-132, a patented molecule from Resolve Therapeutics designed to reduce inflamation, successfully reduced fatigue (a challenging symptom to treat) in a phase 2 study of SS patients. A phase 3 study is in the works.
- A phase 2 trial for Petesicatib (RO5459072), a small molecule Cathepsin S inhibitor, has concluded. While the results have been posted, I have been unable to find a summary or future actions.
There are still several drugs in active trials including:
- A phase 3 trial for IVIG is currently underway for SS-related neuropathies. This treatment has been available off-label, but a successful trial could mean better insurance coverage for SS patients.
- A small phase 2 trial for Parsaclisib, a kinase inhibitor.
On the dryness side, there are some dry eye treatments making their way through the clinical pipeline:
- LO2A, an eye drop made by a German company, is currently in a phase 4 trial in Israel following a successful phase 2 trial.
- DNase eye drops had a successful phase 1/2 trial earlier this year.
- TearSolutions is doing well with their own phase 2 trial for their eye drop product Lacripep and eying a larger phase 3 trial to follow.
- TrueTear, a device to stimulate tear flow from Allergan, is in a phase 2 trial for SS patients.
- Levocarnitine, a drug used to treat patients with kidney disease, is in an early phase 2 trial for dry eye in SS patients.
If you know of any other interesting clinical trial updates, feel free to reach out to me.