lactic acid injection (STA363) / Stayble Therap - LARVOL DELTA

STA363 in the Treatment of Lumbar Disc Herniation (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Stayble Therapeutics | Recruiting ➔ Completed

Trial completion • Musculoskeletal Diseases

STA-02: Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain (clinicaltrials.gov) - P2 | N=110 | Completed | Sponsor: Stayble Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

A Proof-of-Concept Study on the Effects of STA363 on Low Back Pain in Patients with Degenerative Disc Disease. (PubMed, Spine (Phila Pa 1976)) - "While MRI results were consistent with fibrosis of the NP after treatment with STA363, these changes did not translate into any significant effects on LBP in DDD patients as compared with patients injected with placebo."

Journal • Back Pain • Fibrosis • Immunology • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Stayble Therapeutics engages Ferghana Partners to support partnering activities [Google translation] (Cision) - "Stayble Therapeutics AB...announces today that the Company has entered into an agreement with the transaction advisor Ferghana Partners ('Ferghana') ahead of the upcoming clinical results from the phase 2b study STA363 with patients suffering from chronic back pain caused by degenerative disc disease. Assuming positive results, Ferghana will assist Stayble with international partnering activities for STA363, accelerate such activities and complement Stayble's current resources....In the study, all patients have recently completed their follow-ups, and top line results are expected to be presented in November or early December 2023."

Licensing / partnership • P2b data • Trial status • Back Pain • CNS Disorders • Pain

First patient included in Stayble Therapeutics' clinical phase 1b study in disc herniation [Google translation] (Cision) - "Stayble Therapeutics AB...announces today that the first patient has been included in the Company's clinical phase 1b study with STA363 for the treatment of herniated discs....The Phase Ib trial for herniated discs is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability. Furthermore, it will measure the effect on disc volume, leg pain and disc intensity as secondary objectives....After an injection of STA363/placebo, four follow-up sessions are carried out, first after one week followed by one, three and six months. The overall results of the study are expected to be presented at the end of H1 2024. The study is being conducted at four clinics in Poland in collaboration with the crown tract research company Cromsource."

Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

STA363 in the Treatment of Lumbar Disc Herniation (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Stayble Therapeutics

New P1 trial • Musculoskeletal Diseases

STA-02: Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: Stayble Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ Sep 2023

Enrollment closed • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

90% have completed twelve-month follow-up in Stayble Therapeutics' ongoing Phase IIb study [Google tanslation] (Cision) - "Stayble Therapeutics AB...today that approximately 90% of all patients in the Company's ongoing phase IIb study in degenerative disc diseases have completed their twelve-month follow-up. The study continues to be of high quality with a low drop-out rate. In connection with all patients completing their six-month visit in February 2023, Stayble was able to secure all critical data to evaluate the phase IIb study's primary efficacy objective. As a result of the continued low number of dropouts from the study, Stayble has now successfully completed the twelve-month follow-up in approximately 90% of the patient population. This means that all critical data from the six-month follow-up and most of the study's data have been secured. The study continues according to plan and Stayble intends to present top-line data from the study during Q4 2023."

P2b data • Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Stayble presents further positive interim data [Google translation] (BioStock) - P2b | N=126 | NCT04673461 | Sponsor: Stayble Therapeutics | "...Stayble Therapeutics presented positive interim data for 100 patients in the phase IIb trial of STA363 for the treatment of degenerative disc disease. The interim analysis shows that the injection treatment is safe and that the pain measurements have low dispersion, which is beneficial for the final data reading at the end of the year. BioStock contacted the company's CSO Anders Lehmann to learn more about the progress of the study....The company's goal is to present top-line data in the fourth quarter of 2023....Now 100 patients have completed their six-month visit and Stayble has thus been able to carry out an interim analysis based on blinded data from these patients. On April 5, the company announced that the results show good safety and tolerability and that no serious side effects have been observed."

P2b data • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

Stayble Therapeutics attended the Bio International Convention in Boston [Google translation] (Cision) - "As part of Staybles Therapeutics' ("Stayble") strategy to find a development partner, the company participated last week at the international event Bio International Convention in Boston. During the convention, Stayble presented to a number of actors who may be relevant to take the Company's drug candidate to the market....The purpose of Stayble's participation was to follow up on existing contacts and map out additional interesting partnering companies with the ability to take the drug candidate STA363 through a phase III study and market approval."

Licensing / partnership • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Stayble is done with the 6-month follow-up (Cision) - "At the beginning of the week, the pharmaceutical company Stayble Therapeutics achieved an important milestone in the phase IIb study with STA363 when 100 patients had completed their 6-month visit. This means that Stayble has secured all the necessary data required to evaluate the study’s primary endpoint – to show pain reduction in patients with chronic disc-related back pain. Stayble is now one step closer to presenting top-line data, which is expected to take place during the fourth quarter of 2023."

P2 data • Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

Stayble Therapeutics receives approval to start Phase Ib clinical trial with STA363 for the treatment of herniated discs [Google translation] (Dagens industri) - "Stayble Therapeutics AB...announces today that the Company has received the go-ahead to start the first clinical study with its drug candidate against herniated discs....The Phase 1b study will be conducted in Poland and performed in collaboration with the contract research company Cromsource. The primary goal of the study is to evaluate safety and tolerability. Furthermore, the effect on disc volume, leg pain and disc intensity will be measured as secondary objectives. A total of 24 patients will be randomized to STA363 or placebo (2:1 allocation). After a single injection of STA363, four follow-up sessions are carried out, after one week and one, three and six months. The overall results of the study are expected to be presented and available during the end of H1 2024."

New P1 trial • P1 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Stayble Therapeutics presents the ongoing phase 2b study at the European Congress on Clinical Trials in Pain [Google translation] (Cision) - "Stayble Therapeutics AB...announces that the Company's ongoing phase 2b study has been accepted for poster presentation at the 4th European Congress on Clinical Trials in Pain (SOPATE2022). The congress will be held in Vienna, Austria, on December 7-8, 2022. Stayble announces that the Company will present the ongoing phase 2b study with STA363 at the European Congress on Clinical Trials in Pain in Vienna. The abstract is entitled Safety and Tolerability of STA363 in Patients with Degenerative Disc Disease and will be presented by Anders Lehmann, Chief Scientific Officer (CSO) at Stayble."

P2b data • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

Stayble Therapeutics publishes quarterly report for the third quarter of 2022 [Google translation] (Cision) - "Stayble has had an abstract accepted for a poster presentation at the 4th European Congress on Clinical Trials in Pain (SOPATE2022). The congress will take place on 7-8 December 2022 in Vienna, Austria. We look forward to presenting STA363 and our clinical study to experts in the field."

Clinical data • Back Pain • CNS Disorders • Pain

Stayble Therapeutics reaches important milestone - phase IIb study fully recruited [Google translation] (Cision) - "Stayble Therapeutics AB...announces today that the last patient has been included in the ongoing phase IIb clinical study with STA363 against chronic discretized back pain. The recruitment is thus completed. The patients are followed for 12 months after inclusion. Final results from the study are expected to be available in Q4 2023 after the Company has compiled and analyzed data from all treated patients in the study."

Enrollment closed • P2b data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Stayble Therapeutics has recruited 75% of patients in its ongoing Phase IIb study [Google translation] (Cision) - "Stayble Therapeutics AB...announces today that the Company has recruited 75% of all patients with chronic disc-related back pain to the ongoing clinical phase IIb study with STA363. The company has made several efforts to increase the recruitment of patients for the study at the participating clinics in Russia, the Netherlands and Spain. These activities, together with a reduced impact of the Covid-19 pandemic, have resulted in a sharp increase in recruitment rates and activity at the clinics involved. The recruitment speed is in line with the set schedule and the ultimate goal of recruiting all patients during the year."

Enrollment status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Initiation analysis Stayble Therapeutics: Unique treatment for disc-related back pain [Google translation] (Aktiespararna) - "...Study results from the ongoing phase 2b study are expected in 2023, and with continued successful development, the market can be reached in 2028."

Launch • P2 data • Back Pain • Pain

Stayble Therapeutics presented at Stora Aktiedagen Stockholm 2021 [Google translation] (Cision) - "Stayble Therapeutics' CEO Andreas Gerward gave a presentation on 30 November 2021 at Stora Aktiedagen Stockholm 2021, which is an event arranged by Aktiespararna....CEO Andreas Gerward presented the Company, the development of the injection treatment STA363 for chronic disc-related back pain, as well as positive interim results from the ongoing phase 2b study."

P2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Stayble Therapeutics presents interim data from an ongoing phase 2b study [Google translation] (Cision) - "Stayble Therapeutics AB...is currently conducting a phase 2b study with the drug candidate STA363. The company has analyzed blinded data and the results show continued good safety and tolerability and indicate good opportunities for a conclusive outcome of the study....The Board estimates that the slower patient recruitment means that study results can only be presented in 2023....The aim of the study is to confirm the safety and tolerability of STA363 and to demonstrate a reduction in pain and increased function in patients with chronic disc-related back pain. The study will include approximately 100 patients divided into three different groups, two of whom are treated with STA363 in two different doses and one with placebo..."

P2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Stayble decides to carry out a rights issue in order to ensure the completion of an ongoing phase 2b study [Google translation] (Dagens industri) - "In order to complete the ongoing clinical phase 2b study, the Board has decided to carry out a rights issue of approximately SEK 41.5 million (before issue costs)....Provided that the rights issue is fully subscribed, it is the Board's and management's assessment that the Company's operations will be financed until completion and processing of results from the phase 2b study, while the Company is given the opportunity to initiate discussions with potential partners, who have financial resources to pursue the project. Phase 3 clinical trials pending market approval."

Financing • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain

STA-02: Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain (clinicaltrials.gov) - P2; N=126; Recruiting; Sponsor: Stayble Therapeutics

Clinical • New P2 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Stayble initiates capitalization plan and initiates market exploration in order to ensure the implementation of the ongoing phase 2b study [Google translation] (Dagens industri) - "Stayble Therapeutics AB...announces today that the Company's Board of Directors has decided to initiate preparations to secure capital for the implementation of the ongoing phase 2b study....The rights issue if planned approximately SEK 43 million (before issue costs) is intended to be carried out during the first quarter of 2021...'Since the stock exchange listing this spring, we have achieved significant milestones in the development of our drug candidate STA363 for chronic disc - related back pain...In order to continue the implementation of the ongoing phase 2b study, we now intend to secure the capital requirement through a rights issue.'"

Financing • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Stayble starts clinical phase 2b study in Spain [Google translation] (Dagens industri) - "Stayble Therapeutics announced today that the Company has initiated the first clinic in Spain for its clinical phase 2b study with the drug candidate STA363. Patient recruitment begins immediately. The company has now started up clinics in the three countries the study is planned to be conducted in: the Netherlands, Russia and Spain. STA363 is aimed at patients suffering from chronic disc-related back pain."

Enrollment status • Back Pain • Musculoskeletal Pain • Pain

Stayble's Phase 2b clinical trial has now also started in the Netherlands [Google translation] (Dagens industri) - "Today, July 2, 2020, Stayble can announce that the Company has initiated the first clinic in the Netherlands and can now start recruiting patients there. The company has previously started the first clinics in Russia. STA363 is aimed at patients suffering from chronic disc-related back pain....The company expects to be able to recruit these patients for 12 months. Patients will be treated with a single dose of STA363 and should then be followed up for a maximum of 12 months....We are now looking forward to starting the first clinic in Spain as well as additional clinics in the Netherlands and Russia."

Enrollment status • Trial status • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Stayble's Phase 2b clinical trial has started [Google translation] (Dagens industri) - "Today, June 16, 2020, Stayble can announce that the Company has started its phase 2b study with STA363 by the first clinic in Russia is now initiated and can start recruiting patients. STA363 is aimed at patients suffering from chronic disc-related back pain....The study will include about 100 patients and will be conducted at about 20 clinics in the Netherlands, Russia and Spain."

Trial status • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain