Equipped with $160M series A, Alveus debuts into crowded obesity development landscape

Looking to overcome some of the limitations of existing obesity drugs, Alveus Therapeutics has debuted with nearly $160 million in hand and an impressive roster of executives ready to take the biotech’s mission forward.

Alveus, which launched Thursday under the stewardship of former I-Mab CEO Raj Kannan, is aiming to advance an undisclosed number of obesity candidates, with the dual-acting asset ALV-100 leading its current development roster. 

The biotech cites pitfalls common to the obesity medications approved today, such as frequent dosing, tolerability issues and weight-loss maintenance over time, as reasons to embark on its development journey.

Alveus is starting out the gate with a $159.8 million series A financing round, which will buoy mid-stage development of ALV-100 and help support investigational new drug (IND) filings for “several early proprietary development candidates,” including a “highly selective” amylin peptide agonist, the company said in a Jan. 8 press release.

The fundraising was led by New Rhein Healthcare Investors, Andera Partners and Omega Funds. French pharma giant Sanofi also chipped in, alongside Kurma Partners, Avego BioScience Capital and other unnamed investors, Alveus said in its launch announcement.

“Obesity is one of the fastest-growing global healthcare challenges, and today’s therapies leave patients struggling to maintain weight loss over time,” CEO Kannan said in a statement. “ALV-100 and our amylin-based pipeline are being developed to deliver durable efficacy with infrequent dosing, improved tolerability, and meaningfully better body-composition outcomes.”

Alveus' lead candidate ALV-100 is a bifunctional glucose-dependent insulinotropic polypeptide (GIP) receptor antagonist and glucagon-like peptide-1 (GLP-1) receptor agonist fusion protein that Alveus figures can deliver potent and durable weight loss while improving tolerability and “targeting key limitations of current chronic therapies,” the company said.

Of the class of approved incretin drugs for obesity, Novo Nordisk’s Wegovy (semaglutide) targets GLP-1 exclusively, while Eli Lilly’s Zepbound (tirzepatide) acts on that hormone receptor and also as an agonist to the GIP receptor. 

The strategy of going after both targets has proven popular with other developers looking to throw their hats into the obesity ring, such as Amgen with its flagship obesity candidate MariTide. Meanwhile, Novo last summer elected not to take a GLP-1/GIP co-agonist analog forward despite a positive phase 2 trial, citing “portfolio considerations.”

Both agonism and antagonism of the GIP receptor can promote weight loss, though debate remains as to which method of action should be preferred.

Apart from ALV-100, Alveus is emerging with an early portfolio based on “highly selective amylin biology,” the company said in its release Thursday. The biotech is dabbling in both injectable and oral administration and gave special mention to ALV-200, a highly selective amylin receptor 3 (AMYR3) peptide agonist that has now entered the IND-enabling stage.

Alveus added that its portfolio includes small oral molecules and “multifunctional formats” in addition to the main therapies it highlighted in its launch announcement.

“New Rhein founded Alveus to combine a world-class team, cutting-edge science, clinical insight, and an unwavering focus on long-term patient outcomes through the treatment of metabolic disorders,” Nayan Parekh, chairman of Alveus’ board, said in the release. “With this Series A funding, we are accelerating the development of therapies that have the potential to set new standards of care in a therapeutic area with one of the largest health-economic burdens driven in part by the failure to sustain durable weight-loss or health outcomes.”

Alveus’ CEO Kannan is in good company at the biotech’s helm, as he's flanked by several veterans in the metabolic medicine field.

Jacob Jeppesen, Ph.D., who formerly worked as VP and therapy area head for Type 2 diabetes and cardiovascular disease research at Novo Nordisk, has assumed the role of chief scientific officer and head of R&D at Alveus. Meanwhile, Brian Bloomquist, Ph.D., former VP of diabetes, obesity and complications external innovation at Eli Lilly, is serving as the new company’s chief business and strategy officer.

Alveus’ chief technical officer is Xiao-Ping Dai, Ph.D. Aside from holding the same role at IVERIC, she previously served as chief technologist at WuXi Advanced Therapies and held leadership roles at Celgene and Bristol Myers Squibb, Alveus noted.

Obesity remains a highly enticing development target for the industry, with the market for commercial therapies only continuing to grow despite Novo and Lilly boasting a significant head start on the competition.

Large pharmaceutical companies and smaller biotechs alike are getting in on the action, with both Roche and Lilly striking obesity deals earlier in the week.

In Roche’s case, the Swiss drugmaker agreed to pay $100 million to secure a license to certain patents related to the oral GLP-1 candidate it gained in its $2.7 billion buyout of Carmot Therapeutics. The move may help form a bulwark against potential future patent litigation as Roche advances its obesity development goals, Leerink Partners analysts observed.

As for Lilly, the Indianapolis-based pharma on Tuesday struck a research collaboration—potentially worth up to $1.3 billion—with Nimbus Therapeutics to work on a new oral medication for obesity and other metabolic diseases.

Separately, Arrowhead Therapeutics this week reported early-phase data on a pair of gene silencing drug candidates for weight loss.