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Viking sails next-gen oral weight loss drug toward phase 2 after posting 5% weight reduction

As Novo Nordisk races to get an oral successor to the weight loss sensation Wegovy through clinical trials, Viking Therapeutics is raising its sails for an attack.

The biotech unveiled data from a phase 1 multiple ascending dose study of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. After 28 days of daily dosing, 25% of the eight patients who received 20 mg doses of VK2735 saw their body weight fall by 5% or more, Viking reported in a March 26 release. This rose to 57% in the seven patients who received 40 mg doses.

None of the patients who received lower doses of 2.5 mg, 5 mg or 10 mg managed to reach this level of weight loss, according to the data. All treatment-emergent adverse events were mild or moderate in severity, the company noted, as were all gastrointestinal events.

The biotech has already added an additional cohort to the study to assess an even higher dose and is also planning a phase 2 study beginning in the second half of the year, Viking CEO Brian Lian, Ph.D., told analysts on a call this morning.

“Based on the encouraging trajectory of weight loss observed in this study, and the lack of a plateau at 28 days for higher dose cohorts, we believe that further benefits might be anticipated from longer dosing periods and with potentially higher doses,” Lian explained.

Investors gave a warm welcome to the readout, sending Viking’s shares up 17% to $81 when the markets opened on Tuesday.

The readout for the oral formulation of VK2735 comes a month after Viking reported phase 2 data for an injectable version of the drug that demonstrated weight loss of up to 14.7% after 13 weeks of treatment.

When asked this morning how the company envisages the two versions of VK2735 being used, Lian told analysts that the potential niche for an oral treatment would be as a “lead-in to an injectable, more in the primary care setting.”

“If somebody didn’t want to start with an injectable therapy, maybe they could start with an oral for some temporary period of time and then when they see weight loss, realizing the [subcutaneous version] might generate better weight loss, it would probably reduce their resistance to transitioning to an injectable,” Lian added.

Earlier this month, William Blair analysts suggested that the efficacy bar for oral VK2735 should sit at between 4% and 5%, meaning today’s results appear to be on track. However, the analysts used the same note to “reiterate our thesis that the majority of VK2735’s valuation resides in the subcutaneous formulation, which had demonstrated competitiveness against Eli Lilly’s Zepbound.”

Viking isn’t the only one hoping to translate injectable weight loss success into oral delivery. Earlier this month, Novo Nordisk unveiled early phase 1 data suggesting that the next-gen oral weight loss drug amycretin could induce 13.1% weight loss after 12 weeks. Unlike VK2735, which is a dual GLP-1/GIP agonist, Novo Nordisk’s amycretin is a dual agonist of GLP-1 and amylin receptor.

https://www.fiercebiotech.com/biotech/viking-sails-next-gen-oral-weight-loss-drug-toward-phase-2-after-first-clinical-win

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