Pharma News – 23.01.2023 to 29.01.2023

Mankind Pharma invests in Actimed Therapeutics to support the latter’s development of treatment for cancer cachexia.

On 23 January 2023, Mankind Pharma announced its move to invest in the UK-based clinical-stage specialty pharma company Actimed Therapeutics. Actimed could effectively close its second and final tranche of seed financing through this investment. (Pharma News – 23.01.2023)

Actimed has also revealed that it is developing a lead asset, S-pindolol, for treating cancer cachexia. In context to this molecule, the company carried out the PK/PD[1] study. This study proved that S-pindolol was successfully meeting all the pre-defined objectives. Based on this clinical achievement, Actimed is planning Phase 2b/3 studies in cancer cachexia. The study is anticipated to be conducted in strategic markets.

Mankind’s recent investment is believed to support Actimed’s planned clinical activities entailing the preparation for the Phase 2b/3 program for S-pindolol benzoate.

Mankind Pharma’s spokesperson has revealed that the company takes pride in its move to support the further advancement of Actimed Therapeutic’s pipeline. He further added that the company is inspired by

Actimed’s novel pipeline and recognized the significant potential of S-pindolol benzoate as a new therapeutic option for cancer cachexia. The pharma major also hopes to bring innovative new therapies to cachexia patients by working with Actimed.

Abbreviation: 1. Pharmacokinetic/pharmacodynamic

Aculys Pharma and Four H enter into an exploratory research collaboration to study sleep disorders in Japan.

Aculys Pharma and Four H have announced a research collaboration using wearable devices. This will help patients with narcolepsy and EDS[1] associated with OSAS[2].

Aculys Pharma recently established a new pharmaceutical model, DX (digital transformation), in its clinical trials and medicines. According to this agreement, Four H is responsible for launching the collaborative exploratory study. While Aculys will be responsible for collecting the participants’ subjective assessment of their sleep. Besides this, Aculys will also collate the data of the patient’s sleep, activities, and heart rate acquired from the wearable devices. The patients will wear devices each night during the clinical trial period. In conjunction with the other data obtained by the clinical trials, these data will be analyzed to identify sleep-related digital biomarkers.

Background

Through this collaboration, both companies aim to get an objective understanding of narcolepsy, OSAS, and its characteristics. OSAS, obstructive sleep apnea syndrome, is characterized by repetitive episodes of nocturnal breathing cessation due to upper airway collapse.

Moreover, they plan to analyze using AI[3] and other methods. The subjective and objective assessments of the patient’s data obtained by the wearable device. Additionally, through collation and analysis of these data, they plan to develop appropriate digital biomarkers for future clinical trials and clinical settings. (Pharma News – 23.01.2023)

The critical outcomes anticipated in this study are an objective understanding of the patient’s sleep status, analysis of daytime sleepiness patterns, and extraction of sleep characteristics. Other information to be obtained from this study are daytime activity data through comparison with people without symptoms and detection of predictive signs of the onset of daytime sleepiness.

The pharma companies have asserted that this study will help provide an accurate understanding of each patient’s sleep and lifestyle patterns. They also plan to collectively build a comprehensive sleep ecosystem for patients in the long run. This ecosystem will include several components like digital biomarkers to predict health risks and personalized data to improve quality of life and productivity. Additionally, the companies have emphasized that this will entail a quality disease management program that patients can utilize at home.

Abbreviation:

1. EDS- Excessive daytime sleepiness.

2. OSAS- Obstructive sleep apnea syndrome is characterized by repetitive episodes of nocturnal breathing cessation due to upper airway collapse.

3. Artificial Intelligence.

USFDA issues OAI notice for Torrent Pharma’s Indrad facility in Gujarat.

Torrent Pharma has received the USFDA’s [1] inspection classification OAI[2] for the company’s Indrad facility in Gujarat. The pharma major revealed that this notice was issued after the USFDA inspected the company’s manufacturing facility and issued Form 483 with three observations.

In response to this notice, Torrent Pharma has clarified that it will not impact this facility’s existing supplies or revenues. This manufacturing facility produces formulations and active pharmaceutical ingredients (API) with an annual capacity of 30 million vials. (Pharma News – 23.01.2023)

Per the OAI, regulatory or administrative action is recommended by the FDA. The pharma company often gets the regulatory body’s clearance after implementing these recommendations.

Abbreviation:

1. USFDA- United States Food and Drug Administration.

2. OAI- Official Action Indicated.