Sanofi - 25년 1분기 실적발표 (1Q25 Earnings)

press-release.pdf

0.27MB

 

2025-04-24 Sanofi의 25년 1분기 실적발표

2025_04_24_Sanofi_Q1_2025_Results.pdf

4.23MB

 

실적 숫자는 별로 관심 없고 I&I 분야 업데이트 사항들 기록

 

amlitelimab (OX40L mAb)

• Preliminary results from the TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) in patients with moderateto-severe asthma showed that amlitelimab achieved clinically meaningful and durable efficacy on exacerbations, lung function, and symptoms, particularly in heterogeneous inflammation. However, the primary endpoint of exacerbations at high dose did not reach statistical significance due to the nature of this limited phase 2 study. As a result, subsequent endpoints are exploratory. In certain subgroups, including patients with high eosinophils and elevated neutrophils, the reduction in exacerbation reached more than 70%. Amlitelimab was generally well tolerated with no new safety concerns identified. Full results will be presented at a forthcoming medical meeting.

• The COAST 1 (clinical study identifier: NCT06130566) and SHORE (clinical study identifier: NCT06224348) phase 3 studies, part of the OCEANA study program in AD have completed patient recruitment ahead of schedule. The recruitment of patients proceeded efficiently, providing the opportunity to optimize the overall sample sizes and robustness of the studies. The OCEANA program is anticipated to read out in 2026 and will provide the foundation for potential regulatory submissions.

 

TIDE-Asthma 임상 2상 결과는 PR로 이미 발표했던 내용. 통계적 유의성은 없었음.

특정군에서 좋은 시그널이 나와서 임상 3상 진행 계획.

 

COAST1과 SHORE 임상 3상은 등록 마감.

 

Amlitelimab 임상 진행 현황:

HS 적응증 임상 2상 결과가 예상되던 시점인데, Amlitelimab에는 언급 없었고 Brivekimig에 언급이 있었음.

Amlitelimab HS 적응증 효능이 안나와서 HS 적응증에 대해서는 Brivekimig으로 집중하겠다고 함. (아래 참고)

 

 

brivekimig (TNFxOX4OL Nanobody® VHH)

• Preliminary results from the HS OBTAIN phase 2 study (clinical study identifier: NCT05849922) in patients with hidradenitis suppurativa (HS) naïve to biologics showed that brivekimig achieved its primary objective1 and showed clinically meaningful improvements in HiSCR50 and other endpoints. The safety profile was in line with expectations with no new safety concerns identified in the 28-week treatment period. Brivekimig, combining dual tumor necrosis factor alpha and OX40 ligand (OX40L) inhibition will be prioritized for further development in HS as OX40L monotherapy (amlitelimab) did not show comparable efficacy in the HS phase 2 study (clinical study identifier: NCT06118099). Full results will be presented at a forthcoming medical meeting.

• The T1D OBTAIN phase 2 study (clinical study identifier: NCT06812988) of brivekimig compared with placebo to preserve βcell function in adults (part A) and adolescents (part B) recently diagnosed with type 1 diabetes and on insulin therapy commenced dosing the first patient.

 

HS OBTAIN는 결과가 좋게 나와서 HS 적응증에서 Brivekimig을 우선순위로 개발하겠다.

결과는 추후 학회 발표 예정이라고 함.

 

Brivekimig 임상 진행 현황:

 

 

balinatunfib (oral TNFR1si)

Preliminary results from the SPECIFIC-PSO phase 2 study (clinical study identifier: NCT06073119 ) in patients with psoriasis showed that balinatunfib was generally well tolerated across doses with no new safety concerns and the potential for differentiated safety. Further, balinatunfib achieved clinically relevant PASI-75 responses, with efficacy levels comparable to other oral medicines in psoriasis. However, the primary endpoint of PASI-75 did not reach statistical significance due to the nature of this limited phase 2 study. As a result, subsequent endpoints are exploratory. With the results obtained, balinatunfib could be well suited for combinations and internal assessments and external discussions are ongoing on potential combinations, including fixed-dose combinations in various diseases. Full results will be presented at a forthcoming medical meeting.

 

Oral TNFR1 inhibitor는 SPECIFIC-PsO 임상 2상에서 통계적 유의미한 PASI-75 결과를 확인하지 못했다고 함.

임상 2상의 제한적인 영향이 크다고 하는데, combination 얘기하는거 보니 만족스럽지는 않았던것 같음.

(사실상 중단?)

RA 적응증 임상 2상 결과는 25년 하반기 예상. (LSLV가 7월 15일이기는 한데, 그닥 기대감 안갖아도 될듯?)

 

Balinatufib 임상 진행 현황:

 

Lunsekimig (IL-13 x TSLP Nanobody® VHH)

PR 언급은 없지만, Presentation 자료에 Asthma, AD, COPD 진행중이다 정도로 나와 있는 정도

IL-13랑 TSLP는 이미 증명된 MoA에다가 nanobody라 tissue penetration 그마나 낫지 않을까

 

 

관심있게 봐야되는 예상 마일스톤:

25년 상반기:

- Balinatufib in RA

- Itepekimab in COPD

25년 하반기:

- Itepekimab in COPD

정도 밖에 없는것 같고 나머지는 죄다 26년에나 기대되는 마일스톤들.