Roche Fast-Tracks Obesity Drug Development, Eyes Over $3B Sales Potential

At its Pharma Day, Swiss pharmaceutical giant Roche Holdings AG RHHBY outlined five priority therapeutic areas: neurology, oncology and hematology, immunology, ophthalmology, and cardiovascular, renal, and metabolism diseases.

The company shared an ‘initial set of assets designated for acceleration based on exceptional potential.’

To maximize potential, the company plans to expedite enrollment with additional clinical trial sites, reallocate resources, and expand into additional indications.

Also Read: Roche Misses Out On Weight-Loss Blockbuster Drug, Now Playing Catch-Up In Booming Market.

The selected fast-tracked programs include:

• CT-388 (RG6640) for obesity entered the Phase 2 stage of development in patients with or without type 2 diabetes and comorbidities.
• Roche expects a commercial launch for CT-388 beyond 2028.
• Trontinemab is currently in Phase 2 for Alzheimer’s. Potential launch in 2025-2028.
• Anti-TL1A Inflammatory Bowel Disease candidate in Phase 3 stage of development.

Roche’s push into the obesity space follows the success of competitors like Novo Nordisk A/S NVO and Eli Lilly And Co LLY, which have seen significant demand for weight-loss drugs like Wegovy and Zepbound.

Additionally, Roche highlighted the financial potential of its obesity drug candidates, projecting that early-stage assets acquired from Carmot Therapeutics (CT-388/CT-996/CT-868) could generate over 3 billion Swiss francs ($3.55 billion) in annual sales.

In July, Roche announced topline results from two arms of an ongoing multi-part Phase 1 clinical trial for CT-996 for type 2 diabetes and obesity.

The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks.

In line with its broader strategy, Roche plans to cut drug development costs by 20% and reduce the time it takes for drugs to move from discovery to the end of Phase 3 trials by 40%, aiming to launch 20 transformative medicines by 2030.

The company is targeting three times as many patients during the 2020-2029 period.

Monday, Roche agreed to acquire a portfolio of next-generation CDK inhibitors for breast cancer from Regor Pharmaceuticals.

Regor will receive an upfront cash payment of $850 million and is eligible for additional milestone cash payments.

Roche’s Genentech will be responsible for clinical development, manufacturing, and commercialization worldwide.

Regor will continue to manage the two ongoing Phase 1 trials to their completion.

The deal is expected to close in the fourth quarter of 2024.

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