Pfizer and Eli Lilly said today they are gearing up to resume the Phase III clinical program for tanezumab after nearly five years—with Pfizer expecting to receive $200 million upfront from Lilly as a result.
The resumption of tanezumab development comes as the FDA has lifted a partial clinical hold on the chronic pain treatment. The agency’s decision followed a review of nonclinical data intended to characterize the sympathetic nervous system response to tanezumab.
“We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” Steve Romano, M.D., svp and head of global medicines development at Pfizer’s Global Innovative Pharmaceuticals Business, said in a statement.
Tanezumab is a humanized monoclonal antibody designed to selectively target nerve growth factor (NGF), a regulator of pain processing and sensitivity. Tanezumab selectively binds to NGF, inhibiting it from activating pain-signaling neurons.
The partial clinical hold had been in effect for tanezumab and all other anti-nerve growth factor antibodies since December 2012, following adverse changes in the sympathetic nervous system of mature animals.
Studies in terminal cancer pain involving tanezumab were allowed to proceed. However, the partial hold affected all anti-NGF compounds in development, including the Johnson & Johnson Phase III candidate fulranumab, and the Phase II candidate fasinumab (REGN475/ SAR16487), being developed by Regeneron with Sanofi.
In January, J&J CEO Alex Gorsky identified fulranumab as one of 10 ten new product filings the company anticipated between 2013 and 2017. The company is planning four Phase III studies of fulranumab—none of which was yet open for participant recruitment as of earlier this month, according to ClinicalTrials.gov. No current or planned trials involving fasinumab were listed on the website, though seven older trials involving the compound have been completed, terminated, or withdrawn.
In placing a partial clinical hold, the FDA modified what was originally a complete clinical hold placed on tanezumab and the other anti-NGF compounds two years earlier at the agency’s request.
The request followed Pfizer’s June 2010 suspension of a Phase III clinical trial for the drug candidate in patients with osteoarthritis (OA), after what the company said was a small number of reports that osteoarthritis patients receiving tanezumab experienced worsening of their disease and needed joint replacements. Pfizer halted two additional clinical trials a month later.
In previous clinical studies assessing more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy versus placebo and other select commonly used pain medicines, Pfizer and Lilly said.