Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep

Author: Vandana Singh | August 14, 2024 12:29pm

On Wednesday, Acelyrin Inc. (NASDAQ:SLRN) confirmed that it was completing a 33% reduction in its workforce.

On June 30, the Agoura Hills, California-based company had $635.2 million in cash, cash equivalents, and short-term marketable securities. The cash runway extends to mid-2027.

“Consistent with our commitment to disciplined capital allocation, we have decided to focus our efforts toward rapidly advancing lonigutamab through late-stage development with our existing cash resources,” said Mina Kim, CEO.

Meanwhile, Acelyrin will cease developing izokibep. The company is on the hunt for a partner to help develop the drug.

Acelyrin reported data from the Phase 3 trial of izokibep in hidradenitis suppurativa (HS). Izokibep demonstrated statistically significant responses across multiple efficacy endpoints at 12 weeks.

• In higher-order endpoints, 25% of patients achieved HiSCR90, compared to 9% on placebo (p-value=0.0009), and 22%  achieved HiSCR100, compared to 8% on placebo.
• HiSCR90 and HiSCR75 are defined as at least a 90% or 75% reduction from baseline in the total abscess and inflammatory nodule count.
• The primary endpoint was measured at 12 weeks; Acelyrin continued dosing patients in a placebo-controlled manner through week 16.
• The company has data from two-thirds of patients in week 16, and the preliminary data demonstrates the continued deepening of HiSCR responses over time.
• No new safety signals for izokibep were observed. The most common adverse events were mild-to-moderate injection site reactions, headache, nasopharyngitis, fatigue, and diarrhea.
• There were no cases of candida infection, liver toxicity, or suicidal ideation/behavior in the izokibep treatment arm.

Acelyrin will complete the ongoing psoriatic arthritis (PsA) and HS trials but will suspend new investments in these indications.

Strategic Shift: The company is prioritizing lonigutamab, signalling a “strategic shift” from izokibep.

“Combined with a reduction in force, this strategic shift allows us to extend our cash runway to mid-2027 and fully fund both Phase 3 trials for lonigutamab,” Kim said.

Acelyrin has completed the Phase 1 proof-of-concept portion of the ongoing lonigutamab trial, and the dose-ranging Phase 2 portion in thyroid eye disease patients continues.

The Phase 2 trial tests different doses and dose regimens to establish a minimum effective dose and enable the selection of the optimal dose and dose regimen for the Phase 3 program. Dose administration every three or four weeks is now being tested.

Acelyrin plans to forgo the originally planned Phase 2b/3 trial design and move directly into a Phase 3 program, potentially with concurrent trials, which is anticipated to be initiated in the first quarter of 2025.

The company will hold an end-of-Phase 2 meeting with the FDA later this year.

Price Action: SLRN stock is down 17.4% at $3.93 at last check Wednesday.

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