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Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep
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Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep
Aug 14, 2024 9:45 AM

On Wednesday, Acelyrin Inc. ( 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 ( SLRN ) will cease developing izokibep. The company is on the hunt for a partner to help develop the drug.

Acelyrin ( SLRN ) 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 ( SLRN ) 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 ( SLRN ) 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 ( SLRN ) 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 ( SLRN ) 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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