Category Archives: SM04554

Biosplice Therapeutics, Dalosirvat, Samumed, SM04554

Biosplice Therapeutics: Rebrand of Samumed

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Update: February 2022

Samumed Ends Hair Loss Program

The biggest disgrace in the history of the hair loss world just happened. At least on par with the past failures of Histogen, Aderans and Intercytex. Update 2023: And now Follica too.

Biospice (formerly Samumed) just layed off its staff and axed its baldness program. After fooling us for a decade and implying that FDA approval was close. Their insane valuation was always a red flag. But I still got carried away after they finished Phase 3 clinical trials in 2021.

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, SM04554, Wnt/Beta-Catenin

Samumed’s Compound Structure

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I have covered Samumed and its SM04554 compound to treat hair loss dozens of times in the past. The company’s Phase 3 Trials end in 2020.

Samumed is aiming to treat numerous medical and cosmetic conditions via activating and/or modulating the Wnt signaling pathway. Of all those targeted conditions, androgenic alopecia is the furthest ahead and the only one that is currently in Phase 3 Trials:

Samumed Pipeline 2019
Samumed Pipeline: https://www.samumed.com/pipeline/default.aspx

Samumed Compound Structure

A few days ago, a reader named “Thomas” emailed me about a new Samumed patent (Publication date = November 22, 2018; Filing date = December 27, 2017).

Thomas pointed out something very interesting. For the first time ever, Samumed has published the chemical structure of its main Wnt/ß-catenin signaling compound. Right under the section titled “Abstract” in the above linked new patent.

Samumed Compound Molecule
Samumed’s Compound Chemical Structure.

Samumed has a decade-long online trail of numerous filed patents, with the vast majority of them including the names of their key scientists John Hood and Sunil Kumar. I have not tried to go through all of these online patent documents, especially those not focused on androgenetic alopecia (male pattern hair loss).

So I am not certain if the above chemical compound structure image is the first time that it has ever been released. It is also not clear if all of  Samumed’s products will be very close in structure to the above compound image. The company has published compound images in the past that look very different from the above (e.g., the one in here for cancer treatments; another in here for Indazole-3-carboxamides and their use as Wnt/β-catenin inhibitors and more).

It would be useful if readers (especially the Chemistry experts on here) provide relevant feedback to this post. For example:

  • What does this compound’s molecular structure mean and how is it unique from other compounds (Samumed ones and non-Samumed ones) that modulate Wnt/ß -catenin signaling?
  • How does this latest compound image differ from other related compound images that Samumed has published in the past?
  • If this really is the first time that this particular image has been released by Samumed, why so late in the process?