Category Archives: Samumed

Biosplice Therapeutics: Rebrand of Samumed

Biosplice Therapeutics
Biosplice Therapeutics Logo.

In a surprising twist, Samumed just rebranded itself as Biosplice Therapeutics (San Diego). CEO Osman Kibar has stepped down. The new CEO is Cevdet Samikoglu. In 2021, the company is supposed to release much anticipated results of Phase 3 clinical trials for its hair loss product.

Biosplice Therapeutics (formerly Samumed)

Biosplice also just raised $150 million in new equity financing investment. This latest round of financing will allow the company to accelerate the development and launch of its osteoarthritis drug candidate Lorecivivint.

The name Biosplice (rather than Samumed) more closely resembles the company’s alternative pre-mRNA splicing technology. It seems like splicing has becoming the company’s new buzzword or brand. Rather than the prior Wnt signaling pathway. From their updated site:

“Biosplice’s mission is to restore health by delivering first-in-class therapies that harness alternative splicing.”

Biosplice’s small molecule technology will make use of alternative splicing to target the CLK/DYRK family of kinases. Oncology and cancer treatment (Cirtuvivint) will be a key focus area of research. Alzheimer’s disease and other degenerative condition will also remain key target areas of treatment.

The renamed company already has a short wikipedia entry.

Dalosirvat (formerly SM04554)

I was initially concerned at the rebranding and the new company’s focus shifting away from the Wnt pathway. However, then I noticed that their androgenetic alopecia drug has been renamed from SM04554 to Dalosirvat.

In my opinion, this is good news. If their soon-to-release Phase 3 clinical trial results are expected to be poor, why go through a product renaming?

Update: The guys on HLT seem skeptical. Some think that the renamed company might be preparing itself for an initial public offering (IPO).

Regarding Dalosirvat, the redone website says:

“The ongoing phase 2/3 study is fully enrolled with data availability expected in 2021.”

More information on the Wnt pathway activator Dalosirvat hair growth molecule can be found here.

Samumed Expects 2021 or early 2022 FDA Approval

I have covered Samumed (US) close to 20 times on this blog. In 2018, the company started Phase 3 clinical trials for its androgenetic alopecia (SM04554) topical product.

Samumed Pipeline 2019
Samumed pipeline. Androgenetic Alopecia is third from bottom.

Can Samumed Release Hair Loss Product in 2022?

Yesterday, Samumed’s CEO Dr. Osman Kibar gave an interesting interview to Fierce Biotech (h/t reader “John Doe”). The most relevant part of this interview for us is:

“Its alopecia treatment is close behind, with approval anticipated in late 2021 or early 2022.”

Not a surprise as far as time frame goes, but Mr. Kibar seems confident that they will get approval. I am assuming he agreed with the above sentence in the interview or was quoted as such.

Not sure if other CEOs “anticipate” approval chances before Phase 3 trials are complete. I am hoping that Samumed has seen good results during the first year of ongoing Phase 3 trials in order to warrant this confidence.

The interview also has some interesting information about the scientific reasoning behind why Samumed’s products are safe despite targeting the critical Wnt pathway.