Bayer ready to take rival to Astellas' Veozah to regulators after phase 3 hat trick

Bayer's hot flash drug elinzanetant has struck phase 3 gold again by relieving vasomotor symptoms, setting up the pharma to approach regulators about following Astellas’ Veozah to market.

The German drugmaker kicked off the year with a pair of late-stage wins from the OASIS 1 and OASIS 2 trials, which assessed the molecule against four co-primary endpoints that looked at the severity and frequency of hot flashes after four and 12 weeks of treatment.

Now, Bayer has announced that in the OASIS 3 study, elinzanetant successfully hit the primary endpoint of demonstrating a statistically significant reduction in the frequency of moderate to severe hot flashes at Week 12.

The study of 628 postmenopausal women also assessed the long-term safety profile of the oral, once-daily drug over 52 weeks, which Bayer said was “overall consistent with previously conducted studies and published data on elinzanetant.”

As with its two predecessor trials, Bayer didn’t provide any specific data on how the drug performed, meaning it remains unclear how elinzanetant ranks against Astellas’ Veozah. Instead, the company only said the results from all three studies will be “presented at upcoming scientific congresses.”

Still, Bayer clearly believes it has the goods. Armed with data from the OASIS trilogy of studies, the pharma will make approval applications to regulators for elinzanetant as a treatment for moderate to severe vasomotor symptoms—a term for hot flashes—associated with menopause.

“OASIS 3 was designed to address the important question of the long-term profile of elinzanetant,” Bayer Global Head of R&D Christian Rommel, Ph.D., said in this morning’s release. “With the positive topline results of OASIS 3 adding to the existing evidence from OASIS 1 and 2, elinzanetant has consistently shown positive data across all phase 3 clinical trials in the treatment of moderate to severe VMS associated with menopause.”

Astellas secured FDA approval for Veozah last year, having brought on the drug as a part of the 2017 acquisition of Ogeda. Bayer entered the race in 2020 when it bought KaNDy Therapeutics, which was working on elinzanetant.

Both molecules are designed to bring relief for hot flashes without using hormones. However, elinzanetant has a slightly different mechanism than Veozah, acting on neurokinin-1 (NK-1) and 3 rather than just neurokinin-3.

Other researchers have linked antagonism of NK-1 to effects on insomnia and mood disorders unrelated to menopause, suggesting Bayer’s dual-target approach may help improve sleep. Bayer’s decision to keep the phase 3 data under wraps for now means the clinical impact of the mechanism still remains unclear.

Bayer also has another study, OASIS 4, underway that is expanding the phase 3 program to assess elinzanetant in women whose hot flashes are caused by endocrine therapy for breast cancer.