What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of effect size, with 39% of patients in the 50-mg EFX group showing a one-stage or greater improvement in fibrosis with no worsening of MASH, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 100% at midday.
Veru weight loss study hits primary endpoint, stock drops
Positive data for Veru Inc.’s enobosarm lend more weight to the potential progress of the company’s body-mass preservation program in patients taking Wegovy (semaglutide). Top-line data of the phase IIb Quality study of enobosarm, a selective androgen receptor modulator that acts much like testosterone, showed a statistically significant reduction in the loss of lean mass in those taking Wegovy. Those participants lost on average 71% less lean mass than patients who were taking only Novo Nordisk A/S’ Wegovy, meeting the study’s primary endpoint. They also lost an average of 27% more fat mass than those just taking Wegovy. The company’s stock (NASDAQ:VERU), which had risen dramatically in the past month, had dropped 49% at midday to 62 cents per share.
AB2 Bio, Nippon Shinyaku in $686M deal for IL-18 hyperinflammation
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year. That will be followed by development milestones of up to $150 million and commercial milestones and royalties of up to $500 million. Tadekinig is a recombinant IL-18 binding protein that AB2 Bio is developing for a number of IL-18 mediated hyperinflammatory disorders. The deal with Nippon Shinyaku is for primary pediatric IL-18-driven hyperinflammation, an inherited disorder that if left untreated can lead to multi-organ failure and death. There are an estimated 1,000 patients in the U.S. who require chronic therapy. Currently there is no FDA approved drug for treating the disease.
Biohaven’s pre-acquisition deeds lead to $60M payout for Pfizer
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Company Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022. The U.S. Department of Justice alleged that, beginning in March 2020, Biohaven paid speaker honoraria to health care professionals and treated them to meals at high-end restaurants as an inducement to prescribe Nurtec ODT (rimegepant), violating the anti-kickback statute and knowingly causing false claims to be submitted to Medicare and other federal health care programs. Pfizer ended the speaker program when it acquired Biohaven.
Neurons send immune cells to the pancreas to regulate glucose
The liver and pancreas are the main actors in glucose metabolism, but not the only ones. Muscles, adipose tissue and the brain play different roles. However, the prize for the best new actor in glucagon production goes to the innate lymphoid cells, which, according to a study published in Science, respond to intestine neuron signals traveling to the pancreas to control glucose. “Immune cells could contribute to processes that have nothing to do with infection. But most importantly, immune cells contribute to metabolism,” senior author Henrique Veiga-Fernandes, principal investigator at Champalimaud Centre for the Unknown in Lisbon, told BioWorld.
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